Pfizer
Flu-like symptom reports
Female, 26 - 39 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 26 | 2020-12-31 | throat irritation, dizziness |
Pt states got Covid vaccine today ay 730am, shortly after started feeling dizzy and scratchy throat....
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Pt states got Covid vaccine today ay 730am, shortly after started feeling dizzy and scratchy throat. She was sent to the ED. ED treated as follows: Solu-Medrol, Benadryl and Pepcid given intravenously. Patient was monitored in the emergency department for improvement of symptoms. Her throat fullness and pruritus resolved. She feels well and wishes to be discharged home. Pepcid, Benadryl and prednisone prescribed for treatment of any recurrence of allergic reaction symptoms that might occur when she is discharged. She will return to the hospital should symptoms worsen. She returned to the ED the next day and these are notes from that visit: 26-year-old female, past medical history significant for asthma and irritable bowel syndrome presents to the emergency department with complaint of allergic reaction. Patient states she took the Covid vaccine yesterday and with 8 minutes developed tightening in her throat and rash. She presented to the emergency department yesterday and was treated with Solumedrol, Pepcid and Benadryl which relieved her symptoms. She was discharged home with Pepcid Benadryl and prednisone however she has not taken the prednisone because she does not like how it makes her feel. She states this morning she developed tightness in her throat, nausea and felt as if she were going to pass out. She states when her symptoms began she took Pepcid and Benadryl but did not take any prednisone. Upon arrival she is very anxious, talking in complete sentences, no drooling noted 1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243 1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday. Procedures MDM Return the emergency department new symptoms or concerns worsening of current condition.1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243 1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday.
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| 26 | 2021-01-01 | chills, fever, headache | Fever of 101, chills, severe body aches, mild headache, nausea, pain at injection site |
| 26 | 2021-01-01 | dizziness |
Pale and light headed. Given water, ice pack for neck. Rested and monitored for 30 minutes and left...
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Pale and light headed. Given water, ice pack for neck. Rested and monitored for 30 minutes and left walking and without symptoms.
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| 26 | 2021-01-01 | fatigue, chills, sweating |
Vaccine was administered at 12:15 pm on 12/29/2020. I continued to work the remainder of the day. I ...
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Vaccine was administered at 12:15 pm on 12/29/2020. I continued to work the remainder of the day. I began to feel fatigue around 7 pm that afternoon and fell asleep. When I woke up at midnight on 12/30/20 I noticed numbness beginning in my left foot and spreading into my face over a course of 30 minutes. I never noted any muscle weakness, but felt a tingling sensation on the left side of my body. Then I began to experience chills and sweating. I was able to return to sleep around 2 AM. When I woke up at 5:30 the numbness had resolved.
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| 26 | 2021-01-01 | headache, fever |
fever and headache 5 hours after taking shot. Fever and headache lasted roughly 30 hours. Three days...
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fever and headache 5 hours after taking shot. Fever and headache lasted roughly 30 hours. Three days after taking shot started to itch real bad and have hive like bumps. Currently still have itching bumps 4 days after shot
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| 26 | 2021-01-03 | dizziness |
At 2:56pm, associate complained of nausea, lightheadness. Blood pressure was elevated; 165/102; hea...
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At 2:56pm, associate complained of nausea, lightheadness. Blood pressure was elevated; 165/102; heart rate 98bpm; SPO2 99% on room air; Placed in supine position in observation area. Administered Benedryl 50mg oral at 3:25pm; Blood pressure was rechecked at 3:40pm; 141/91; heart rate 88; associated states she felt improved of all symptoms; associate has been cleared to return home; husband will transport
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| 26 | 2021-01-03 | fever, chills |
By evening, arm around the injection site grew increasingly painful, to the point where it hurt to m...
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By evening, arm around the injection site grew increasingly painful, to the point where it hurt to move or touch (not unbearable but more soreness than any other injection I've ever received). Over night contracted a fever, by the time I was able to get up to measure it (around 3:45 AM) it was 99.5 degrees, and broke by 5 AM. Had fever dreams prior to waking around 3 AM, and had chills for the remainder of the night. Felt achy and a little unsteady for the rest of the day but was fully recovered by 12/31
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| 26 | 2021-01-03 | malaise, migraine | Migraine; Feeling foggy; Malaise; Swollen lymph nodes; Could not lift arm more than a few inches |
| 26 | 2021-01-03 | fever, headache |
Severe headache, fever, and blood pressure drop leading to fainting starting the day after receiving...
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Severe headache, fever, and blood pressure drop leading to fainting starting the day after receiving the Pfizer-BioNTech COVID-19 Vaccine EUA.
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| 26 | 2021-01-04 | chills, fatigue, dizziness |
I had a very sore arm; lightheadedness/dizziness; back ached; felt like I had the flu - body aches; ...
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I had a very sore arm; lightheadedness/dizziness; back ached; felt like I had the flu - body aches; felt like I had the flu - body aches; shivering/chills; nausea; fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 26-year-old female patient received bnt162b2 (lot number: EH9899, brand=Pfizer-BioNTech), via an unspecified route of administration, at arm left, first dose on 16Dec2020 10:00, at single dose for COVID-19 immunization. No relevant medical history. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), spironolactone (SPIRONOLACTONE) both from an unspecified date for unspecified indication. The patient is not pregnant at the time of vaccination. Age at vaccination was 26. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. About 12 hours after the COVID vaccine (also reported as from 16Dec2020 21:00), the patient suddenly felt like had the flu-body aches, shivering, nausea, fatigue, chills, but no fever. She went to bed and woke up the next morning (17Dec2020) feeling fine, except she had a very sore arm and was fatigued. Also had some lightheadedness/dizziness that second day and her back ached. No treatment was received for the adverse event. The events were reported as non-serious. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
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| 26 | 2021-01-04 | fever, chills, headache |
Shot was given around 12:40 pm on 1/4/2021. I woke up with shivers and low grade fever (99.6) at abo...
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Shot was given around 12:40 pm on 1/4/2021. I woke up with shivers and low grade fever (99.6) at about 11:30pm. Took a Tylenol at that time. Low grade fever still persists (and rose to 100 degrees at the highest), mild body aches at 6am and headache.
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| 26 | 2021-01-04 | fever, runny nose, headache | headache, low grade fever,runny nose, loss taste and smell, feels flushed |
| 26 | 2021-01-04 | headache, fever |
headache; fever; severe swelling in her lips; This is a spontaneous report from a contactable other ...
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headache; fever; severe swelling in her lips; This is a spontaneous report from a contactable other healthcare professional. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration from 23Dec2020 16:30 at single dose for COVID-19 immunization. The patient's medical history included Crohn's disease. Concomitant medications included paroxetine hydrochloride (PAXIL) and spironolactone. The patient previously took morphine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient was injected with hyaluronic acid lip filler 10 days prior to her vaccine. The patient developed severe swelling in her lips a few hours after she received the vaccine on 23Dec2020. The following day after her vaccine she developed headache and fever too (24Dec2020). The patient went to the Emergency room/department or urgent care and was treated with Benadryl. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. Information about lot/batch number has been requested.
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| 26 | 2021-01-04 | headache |
mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; m...
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mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; This is a spontaneous report from a contactable healthcare professional. A 26-year-old female patient started received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), intramuscular on the left arm on 23Dec2020 09:45 at a single dose for COVID-19 immunisation. Medical history included autoimmune thyroiditis. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 11:00, the patient experienced mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with ibuprofen. Clinical outcome of the events was recovered on an unspecified date in Dec2020. No follow-up attempts are possible. No further information is expected.
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| 26 | 2021-01-05 | fatigue, headache |
-Injection site pain 12 hrs later, pain severe 7/10, arm painful to light touch 18 hrs later: -Flu...
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-Injection site pain 12 hrs later, pain severe 7/10, arm painful to light touch 18 hrs later: -Flushing/hot flashes throughout the day -Persistent headache lasting 24hrs -General fatigue All symptoms subsided after 48 hrs
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| 26 | 2021-01-05 | fever, chills, headache | Fever of 100.3, headache, chills, body aches |
| 26 | 2021-01-05 | chills |
I had nausea all day, heart rate over 120, pelvic & back pain, chills, normal temp of 98.6. Through...
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I had nausea all day, heart rate over 120, pelvic & back pain, chills, normal temp of 98.6. Throughout the day my heart rate was at 125 even at sitting . My blood sugars were completely normal.
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| 26 | 2021-01-05 | shortness of breath |
Patient began having flushing and hives, chest tightness, shortness of breath, voice changes - began...
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Patient began having flushing and hives, chest tightness, shortness of breath, voice changes - began ~20 minutes after occurrence. Given IV benadryl 50 mg immediately - noted some improvement of symptoms. Symptoms persisted, arrived in ER, given IM epi 0.3 mg, PO prednisone 50 mg, and PO pepcid 20 mg approximately 1 hour after administration
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| 26 | 2021-01-05 | dizziness |
Pt states feeling flushed, lightheaded, tingling in hands, chest and feet, and heart racing/palpitat...
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Pt states feeling flushed, lightheaded, tingling in hands, chest and feet, and heart racing/palpitations.
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| 26 | 2021-01-05 | headache, shortness of breath, nasal congestion |
Shortness of breath; chest pain; body aches; joint pain; headache; nausea; congestion; This is a spo...
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Shortness of breath; chest pain; body aches; joint pain; headache; nausea; congestion; This is a spontaneous report received from a non-contactable nurse (who is also the patient). A 26-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El0140), intramuscular in right arm, on 29Dec2020 17:30, at single dose, for COVID-19 immunization. Medical history included spontaneous pneumothorax x2 on the right with VATS surgery on an unspecified date and multiple food allergies. The patient is not pregnant. Concomitant medication included montelukast sodium (SINGULAIR) and loratadine (CLARITIN). The patient experienced shortness of breath, chest pain, body aches, joint pain, headache, nausea and congestion, all on 30Dec2020 at 05:00. The patient did not receive treatment for the events. The patent did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The reporter assessed the case as non-serious. No follow-up attempts are possible. No further information is expected.
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| 26 | 2021-01-05 | headache |
Went to the ER on the 31st, my face swelled and chest was covered in hives. Lips swelled. I would ge...
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Went to the ER on the 31st, my face swelled and chest was covered in hives. Lips swelled. I would get nauseated and I felt like there was acid in my stomach. I also had a headache. I have been taking Zyrtec, Benadryl as needed.
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| 26 | 2021-01-05 | fever, fatigue, headache, somnolence |
Woke up at 0400hrs with a temperature of 99.7, body wide pain, exhaustion, and a headache. Fever rea...
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Woke up at 0400hrs with a temperature of 99.7, body wide pain, exhaustion, and a headache. Fever reached 100.00 by 0530hrs. Fever subsided by 1200hrs. Slept majority of the day. Symptoms went away around 1730hrs.
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| 26 | 2021-01-05 | fever, shortness of breath |
fever 101.8 (resolved within 24 hours) lymphadenopathy (ongoing - submandibular, anterior/posterior/...
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fever 101.8 (resolved within 24 hours) lymphadenopathy (ongoing - submandibular, anterior/posterior/deep cervical) edema of soft tissues i throat on right side making it difficult to swallow SOB n/v/d
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| 26 | 2021-01-05 | fatigue, headache |
on/off mild headache; extreme fatigue; swollen, very tender pea size lymph node by collarbone neares...
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on/off mild headache; extreme fatigue; swollen, very tender pea size lymph node by collarbone nearest to the injection site; This is a spontaneous report from a contactable nurse (patient herself). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) via an unspecified route of administration (arm left), on 18Dec2020 at 10:45, at a single dose, for COVID-19 immunization. Patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included attention deficit hyperactivity disorder (ADHD), anxiety, chronic back pain, and allergies to penicillin. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), baclofen, oxymetazoline hydrochloride (CLARITIN ALLERGIC), and sertraline hydrochloride (ZOLOFT). On 19Dec2020, 24hrs post vaccination, the patient had a swollen, very tender pea size lymph node by collarbone nearest to the injection site, and an on/off mild headache. 48hrs post vaccination, patient had extreme fatigue and on/off headache, still had swollen lymph nodes. The patient did not receive treatment for the events. Outcome of the event swollen lymph nodes was not recovered, while for the other events was unknown. Since the vaccination, has the patient has not been tested for COVID-19.
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| 26 | 2021-01-06 | runny nose, fatigue, headache |
12/23/20- mild arm soreness 12/24-12/25- (worse) very tender arm at injection site 12/24-12/25- ext...
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12/23/20- mild arm soreness 12/24-12/25- (worse) very tender arm at injection site 12/24-12/25- extreme fatigue (literally no energy) 12/24- for a couple to several days- restless sleep/insomnia 12/24- (off an on for a few days) headache and runny nose All symptoms resolved within a week. Only took Tylenol or ibuprofen for headache/arm soreness. Massaged arm to help soreness and applied a cold compress.
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| 26 | 2021-01-06 | chills, fatigue |
I experienced side effects from the COVID vaccine, including notable fatigue, chills/shaking, body a...
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I experienced side effects from the COVID vaccine, including notable fatigue, chills/shaking, body aches for approximately 2 days. The third day I woke up without any symptoms.
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| 26 | 2021-01-06 | shortness of breath, headache, fever, malaise | Skin hurting Restlessness Fever Headache Shortness of breath Seeing flashes Malaise Muscle aches |
| 26 | 2021-01-06 | shortness of breath | Sob that was better after taking off mask- EMT on sight see documents scanned into chart |
| 26 | 2021-01-06 | body temperature increased, headache |
Temporal thermometer reading got up to 105 F, brought down to 102.9 with Tylenol(1,000 mg taken) alo...
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Temporal thermometer reading got up to 105 F, brought down to 102.9 with Tylenol(1,000 mg taken) along with tepid bath and pushing cool oral fluids, headache lasting throughout day making sensitivity to light and noise without being dizzy. ibuprofen taking q6 to help with headache.
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| 26 | 2021-01-06 | fever | fever 101.4 and muscle aches and elevated heart rate all responded to acetaminophen |
| 26 | 2021-01-06 | sweating |
patient received vaccine 0818, in observation area 08:30 reported that she felt cold, sweaty palms ...
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patient received vaccine 0818, in observation area 08:30 reported that she felt cold, sweaty palms and decreased sensation in hands, ate yogurt 2 hours prior to vaccine 08:32 bp: 124/85, o2sat 99%, hr 94, drinking pepsi, ate peanut butter crackers and granola bar 08:40 patient reports palms less sweaty, bp 141/63, hr 90, 1 glucose tablets administered 08:50 glucometer 130, bp 130/65, hr 83 9:10 T 98.0 oral, bp 125/78, hr 83, patient reports hands no longer cold, palms not sweaty, sensation normal in hands 9:22 patient left to go home, states she felt normal
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| 26 | 2021-01-07 | shortness of breath |
1123 Patient received vaccine 1132 Patient complained of shortness of breath and throat closing, 0.3...
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1123 Patient received vaccine 1132 Patient complained of shortness of breath and throat closing, 0.3 MG Epinephrine administered and MOVE/SWAT notified, Vital Signs taken and within normal limits 1135 50 MG IM Benadryl given, SWAT arrived and report given. Patient reports feeling better 1140 Patient transferred to ER by wheelchair
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| 26 | 2021-01-07 | weakness, nasopharyngitis, influenza like illness, dizziness |
24 hours after vaccine, I had typical mild cold/flu symptoms. After 48 hours I had a lot of pain in ...
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24 hours after vaccine, I had typical mild cold/flu symptoms. After 48 hours I had a lot of pain in my injection arm and my armpit lymph nodes were swollen. I treated the pain with Advil and a heating pad. 72 hours after the vaccine I felt faint, dizzy, and nauseous. I began to vomit and have diarrhea that entire night and next morning. I felt very weak and was unable to keep any foods or liquids down. I was unable to walk around. I took Zofran 8mg which helped with the severe nausea and weakness. These symptoms are ongoing.
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| 26 | 2021-01-07 | fever, chills | 24 hours later a 100.8 fever, chills, and muscle aches. |
| 26 | 2021-01-07 | headache, chills, dizziness, weakness, fever, malaise |
About ten hours after the injection, started having severe chills, N/V, severe headache, dizziness, ...
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About ten hours after the injection, started having severe chills, N/V, severe headache, dizziness, fever, severe muscle soreness, active loss of smell and taste. General malaise and weakness.
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| 26 | 2021-01-07 | headache, chills, fever |
Arm pain at injection site; fever of 101; chills; severe body aches; mild headache; nausea; This is ...
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Arm pain at injection site; fever of 101; chills; severe body aches; mild headache; nausea; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot numbe: EK5730), via an unspecified route of administration on the left arm on 31Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included anxiety, and covid prior vaccination: Yes. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. The patient experienced arm pain at injection site, fever of 101, chills, severe body aches, mild headache, nausea on 01Jan2021. The patient received no treatment. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 26 | 2021-01-07 | chills, fever, fatigue | Fever 100.4, chills, joint pain, fatigue, Diarrhea |
| 26 | 2021-01-07 | headache, chills, fever | Fever, chills, body ache, headache |
| 26 | 2021-01-07 | headache, fatigue |
Headache Body ache Fatigue Painful soreness at the injection site Swollen lymph nodes on arm of inje...
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Headache Body ache Fatigue Painful soreness at the injection site Swollen lymph nodes on arm of injection site - painful sore ness Chest pain
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| 26 | 2021-01-07 | throat irritation | ITCHING OF TONGUE AND THROAT; REDNESS OF SKIN ON NECK AND SHOULDERS |
| 26 | 2021-01-07 | dizziness, chills, fatigue, sweating, headache |
Lightheadedness, pounding headache, overall body soreness, feeling hot and/cold, sweating when hot, ...
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Lightheadedness, pounding headache, overall body soreness, feeling hot and/cold, sweating when hot, chills when cold, extreme fatigue and weariness. As of the writing of this form, I am still experiencing some lightheadedness, and this morning, I felt very warm, but I overall feel much better.
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| 26 | 2021-01-07 | fever, headache, chills | Rigors, fever, headache and arm soreness |
| 26 | 2021-01-07 | headache, chills, fever |
Started with headache around 3pm the day after the vaccine administration. Took Advil around 4pm, wi...
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Started with headache around 3pm the day after the vaccine administration. Took Advil around 4pm, with no relief. Nausea started shorty after eating dinner at 6pm. Around 7pm, went to bed and started getting chills and felt feverish (did not have thermometer to record temp). Napped for 3 hours and felt better after. Next morning, feeling milder headache.
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| 26 | 2021-01-07 | headache, migraine, cough |
Vaccinated in left arm 12/29 ? initial soreness Wed 12/30 -Headache onset; pain 5 (out of 10) Thursd...
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Vaccinated in left arm 12/29 ? initial soreness Wed 12/30 -Headache onset; pain 5 (out of 10) Thursday 12/31- some pain/soreness in arms and legs; no HA Friday 1/1- pain worse (7 out of 10); temp 99.8; Sat 1/2 cough in the morning, soreness; in the evening pain worse; cough resolved; Sunday 1/3 extreme pain 10 out of 10; presented to the ED; prescribed Toradol and excedrin Numbness and pain in upper and lower extremities, particularly in R arm; 10 out of 10 pain; 101.0 temperature Monday 1/4 temperature down to 99.5 this am (has been taking Tylenol); still experience significant pain Headache that she describes as migraine worsens with standing up, walking, talking Pain in legs, if stands for more than 10 seconds she experiences extreme pain Denies SOB, wheezing, coughing The ED advised her to take Toradol for 48 hours and contact a PCP for follow up.
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| 26 | 2021-01-07 | fatigue, chills, cough, throat pain, fever |
a slight sore throat and cough with a slight fatigue; a slight sore throat and cough with a slight f...
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a slight sore throat and cough with a slight fatigue; a slight sore throat and cough with a slight fatigue; body aches; chills; fatigue; mild fever; diarrhea; nausea; This a spontaneous report from a contactable nurse (patient). A 26-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EJI685, unspecified route of administration on 30Dec2020 15:45 (at the age of 26-years-old) as 1 single dose in the right arm for COVID-19 immunization. Medical history included Polycystic ovarian syndrome (PCOS) and anxiety. Concomitant medication included ascorbic acid (VITAMIN C) colecalciferol (VITAMIN D), zinc and birth control. The patient was allergic to sulfamethoxazole and trimethoprim (BACTRIM) antibiotics. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The next morning after receiving the vaccine the patient had full body aches, chills, fatigue, mild fever, diarrhea, and nausea. These all resolved within 24 hours as the next day (2nd day after vaccination). The patient felt much better, and only had a slight sore throat and cough with very slight fatigue.The full body aches, chills, fatigue, mild fever, diarrhea, nausea, a slight sore throat and cough with a slight fatigue did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events full body aches, chills, fatigue, mild fever, diarrhea, nausea, a slight sore throat and cough with a slight fatigue. Outcome of the events full body aches, chills, fatigue, mild fever, diarrhea, and nausea was recovered. Outcome of the events a slight sore throat and cough with a slight fatigue was recovering. Since the vaccination, the patient has not been tested for COVID-19.
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| 26 | 2021-01-07 | headache, fever |
drop in blood pressure resulting in fainting; drop in blood pressure resulting in fainting; Severe h...
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drop in blood pressure resulting in fainting; drop in blood pressure resulting in fainting; Severe headache; fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unspecified route of administration on 03Jan2021 at single dose at left arm for immunization. Medical history included allergies to Penicillins. The patient's concomitant medications within 2 weeks of vaccination included birth control pill, prenatal vitamin. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient experienced severe headache, fever, and drop in blood pressure resulting in fainting the morning following receiving the vaccine on 04Jan2021 with outcome of recovering. Patient didn't receive treatment for events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. This report is considered non-serious. No follow-up attempts are possible. Information about Batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the event fainting with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 26 | 2021-01-07 | headache, chills |
headache; Chills; This is a spontaneous report from a non-contactable healthcare professional (patie...
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headache; Chills; This is a spontaneous report from a non-contactable healthcare professional (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular on 31Dec2020 08:45 in arm (reported as left and right) at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, norgestimate (NORGESTIMATE AND ETHINYL ESTRADIOL). It was reported that on 31Dec2020, the patient had chills and headache that started around 11:00 pm on the day the patient received the vaccine. The patient took 400mg of ibuprofen the next morning and had no recurrent symptoms. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on unspecified date. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 26 | 2021-01-07 | influenza like illness, headache |
mild flu-like symptoms; Diffuse myalgias, more severe on both right and left arm; Numbness in lower ...
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mild flu-like symptoms; Diffuse myalgias, more severe on both right and left arm; Numbness in lower legs evening of vaccine; Felt mild headache; foggy feeling this night; This is a spontaneous report from a contactable healthcare professional, reporting for a patient. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EK9231), intramuscular in the right arm on 30Dec2020 at 09:45 (at the age of 26-years-old) as a single dose for Covid-19 vaccination. Medical history included Covid-19 prior to the vaccination on an unknown date. The patient was not pregnant at the time of vaccination. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. On 30Dec2020 at 19:30, the patient experienced diffuse myalgias, more severe on both right and left arm and numbness in lower legs the evening of the vaccine; felt mild headache and foggy feeling that night as well. The second day on 31Dec2020, the patient experienced mild flu-like symptoms such as weakness, fatigue, and myalgias. Therapeutic measures were taken for the myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness which included Tylenol. The clinical outcome of the events myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness was recovered on an unknown date.
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| 26 | 2021-01-07 | headache, body temperature increased, chills |
temperature of 101 °F; body aches; headache; nausea; chills; This is a spontaneous report from a co...
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temperature of 101 °F; body aches; headache; nausea; chills; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old female patient started to receive BNT162B2 (Batch/lot number: EK9231) at right deltoid via an unspecified route of administration on 03Jan2021 12:20 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient experienced temperature of 101 °F, chills, body aches, headache and nausea on 04Jan2021 02:00. Patient stated for the second one, she was hoping for the best, but she got the vaccine yesterday (03Jan2021), at 12:20, and today (04Jan2021), at 2 AM, she had a temperature of 101, and chills, body aches, headaches, and nausea. She was out of it today, she was not feeling good, and was told to do this. Caller got the vaccine at Employee Health. After 4 hours of Tylenol (expiry is May2021, lot is P115252), her temperature went right back up. It was about 99 when she had Tylenol. Chills started late this morning (04Jan2021) and were ongoing when she was not on Tylenol, but her body aches were ongoing. 9AM was when her headache started, and she was intermittently on Tylenol, but if past the 4 hour mark, they were as bad as they were this morning, but with Tylenol they were better. Nausea was mostly this morning, and had gotten better. Patient stated that due to her current symptoms her employer had required her to be tested for COVID-19. She had not yet received the results of that test. Seriousness for events temperature of 101 °F, chills, body aches, headache and nausea was Medically significant. Lab data included COVID test on 23Dec2020 was negative. The outcome of temperature of 101 °F, headache and nausea was recovering; of body aches was not recovered; of chills was unknown. Primary Source Reporter (Method of assessment was Global Introspection) considered the events were related to BNT162B2.; Sender's Comments: There is a reasonable possibility that the events reported were related to BNT162b2 based on known drug safety profile and close temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 26 | 2021-01-08 | throat pain, headache, dizziness |
Allergic reaction to covid shot on 11/8 Around 11:20am I got the shot by 11:25am i was dizzy my thro...
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Allergic reaction to covid shot on 11/8 Around 11:20am I got the shot by 11:25am i was dizzy my throat started to hurt, and my chest started to hurt. I was a shot of EpiPen and benadryl before I was wheeled down to the ED and was given dexAMETHasone at 1:02pm and ibuprofen at 2:36pm cause my head started to hurt more . Arm is till hurting at the injection site
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| 26 | 2021-01-08 | fatigue |
Around 2 am the following day the side effects I was experiencing were fatigue and body/muscle aches...
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Around 2 am the following day the side effects I was experiencing were fatigue and body/muscle aches (severe aches in my lower back and hips). This lasted the entire day until I went to bed around 10 o'clock. I had to use a heating pad for my back to reduce the pain.
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| 26 | 2021-01-08 | fatigue, headache | Body ache, headache, fatigue. |
| 26 | 2021-01-08 | fatigue | Fatigue, body aches for 48 hours. |
| 26 | 2021-01-08 | fatigue |
I had post nasal drip before I got the injection. because of the drip had a wet cough, then later d...
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I had post nasal drip before I got the injection. because of the drip had a wet cough, then later day i started feeling tired. On Christmas eve i went to doctors care and they did a Covid test which was positive. Two weeks later i got an anti-body test.
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| 26 | 2021-01-08 | chills |
Muscle and joint aches, nausea, chills. Worked 6am-1pm (went home early). Slept for 3 hours, no impr...
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Muscle and joint aches, nausea, chills. Worked 6am-1pm (went home early). Slept for 3 hours, no improvements. Hydrated, ate small dinner, went to bed. Woke up 4:45am for work and symptoms were gone.
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| 26 | 2021-01-08 | fever, chills | Myalgia, Fever, Chills Narrative: Took OTC ibuprofen |
| 26 | 2021-01-08 | fever | Myalgia, Fever, F(101.5) Narrative: |
| 26 | 2021-01-08 | fever, headache, chills |
On 01/07/2021 I woke up at 0300am with chills, headache, body aches, joint pain, fever of 101.2 and...
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On 01/07/2021 I woke up at 0300am with chills, headache, body aches, joint pain, fever of 101.2 and swollen left axillary lymph nodes. I took Tylenol and Benadryl and it relieved the fever/headache/body aches/joint pain, however the lymph nodes in my left axillary remained swollen. I continue to take Tylenol for the fever/body aches/pains without relief for the swollen and painful axillary lymph nodes. Warm compresses do help to relieve the pain temporarily but they remain painfully swollen. On 01/08/21 I called my doctors office to ask if it was normal to experience such painfully swollen axillary lymph nodes to which they stated ?we don?t know, it is too soon for us to tell what?s normal and what isn?t normal right now.? They did not offer any suggestions to relieve the pain or swelling. The morning of 01/09/2021 , I called Employee Health at my hospital (my place of work and also where I received the vaccine) and they also stated they didn?t know if this was a normal reaction due to the newness of the vaccine. A couple hours later, employee health emailed me a link to the VAERS reporting website and asked me to file a report.
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| 26 | 2021-01-08 | fatigue, headache, dizziness | Severe headache Dizziness Fatigue |
| 26 | 2021-01-09 | shortness of breath |
About 30 minutes after vaccination, patient notiched itchiness which progressed to hives on her bila...
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About 30 minutes after vaccination, patient notiched itchiness which progressed to hives on her bilateral arms and face. Around two hours after the vaccination while on the phone with our covid vaccine team, she developed tachycardia and shortness of breath. She called EMS and was evaluated at home at which time her symptoms were improving. They advised that she was not having anaphylaxis and could stay at home. She went to urgent care and received PO Benadryl.
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| 26 | 2021-01-09 | chills, throat pain, headache, runny nose, fever, cough |
FEVER 101, BODY aches, chills- 2 days took tylenol, dry cough, sore throat, runny nose, headache- 3 ...
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FEVER 101, BODY aches, chills- 2 days took tylenol, dry cough, sore throat, runny nose, headache- 3 days took tylenol
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| 26 | 2021-01-09 | fatigue, headache |
Headache and fatigue 2-3 post injection, arm soreness approximately 8 hours post injection. Poor sle...
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Headache and fatigue 2-3 post injection, arm soreness approximately 8 hours post injection. Poor sleep night of injection, woke up at 0630 with significant muscle aching, allodynia, and headache
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| 26 | 2021-01-09 | chills | Muscle aches and chills X1 day |
| 26 | 2021-01-09 | chills |
Myalgias, joint aches, nausea, severe rigors and chills starting about 12 hours after administration...
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Myalgias, joint aches, nausea, severe rigors and chills starting about 12 hours after administration of vaccine
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| 26 | 2021-01-09 | throat irritation, throat swelling |
Patient received vaccine at 7:31 am. At 7:37 am patient reported burning at injection site/right arm...
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Patient received vaccine at 7:31 am. At 7:37 am patient reported burning at injection site/right arm. Minutes later started complaining of burning in her throat. Bloor pressure 138/80 Pulse 142 Oxygen 100 Temperature 98.2. Lungs sounded clear. No wheezes. At 7:47, patient reports tightness in throat has subsided but feels swollen, tightness in chest. Is still able to drink water. Blood pressure 140/90 HR 120 Oxygen 100. Called 911. Patient had many questions about receiving Epi Pen. Denies heart conditions, reports has a history increased heart rate. At 7:49 am Epi pen given left lateral thigh. BP 142/78.100% Oxygen, Pulse 129. EMS arrived few minutes after. Blood noted on left lateral thigh at Epi injection site. 2x2 applied with pressure. Report off to EMS.
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| 26 | 2021-01-09 | shortness of breath, sweating, fatigue | Worsening tachycardia, shortness of breath on exertion, diaphoresis, fatigue |
| 26 | 2021-01-09 | skin warm | tennis ball size lump, raised, red, hot to touch, painful |
| 26 | 2021-01-10 | fatigue, fever, headache |
4 hours after administration (1/8/21) I had nausea. The following day (1/9/21) I had a mild fever, b...
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4 hours after administration (1/8/21) I had nausea. The following day (1/9/21) I had a mild fever, body aches, headache, and was fatigued. These symptoms lasted until about 7pm until I took Tylenol. Once I took Tylenol I felt almost immediately better.
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| 26 | 2021-01-10 | shortness of breath, weakness |
Approximately 15 min after vaccination began to experience tingling sensation under tongue. It was n...
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Approximately 15 min after vaccination began to experience tingling sensation under tongue. It was not bothersome so I proceeded to go home. At 2:04 pm, approximately 40 minutes after vaccination was driving home and began to experience an elevated HR, shortness of breath/difficulty breathing and throat tightness. Proceeded to pull over to a gas station and felt extremely weak when trying to walk and a tingling sensation all over. Took 25 mg of Benadryl tablets and symptoms began to subside within about 10 minutes or so. Proceeded to continue driving home and had another episode at 2:49 pm, experienced significant shortness of breath and tingling sensation in mouth spread to back of tongue and it felt swollen. I bought liquid Benadryl instead and took ~20 mL. This episode resolved within 10-20 minutes as well and was okay for the rest of the evening.
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| 26 | 2021-01-10 | chills, influenza like illness, headache |
Approximately four hours after receiving the COVID-19 vaccine I felt injection site pain. During the...
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Approximately four hours after receiving the COVID-19 vaccine I felt injection site pain. During the night I began experiencing muscle aches, chills, headache, and just an overall feeling of pain/flu like symptoms. This lasted for approximately 24 hours.
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| 26 | 2021-01-10 | chills, nasal congestion, fever |
Body aches at 9:00am Chills at 9:00 am Headaches at 9:35 am Stuffy nose 11:00 am Fever of 100.5 at ...
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Body aches at 9:00am Chills at 9:00 am Headaches at 9:35 am Stuffy nose 11:00 am Fever of 100.5 at 1:00pm Last from 12/22/2020 - 12/24/2020
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| 26 | 2021-01-10 | fever, chills | CHILLS, LOW GRADE FEVER AND BODY ACHES. SYMPTOMS LASTED 8 HOURS AND SUBSIDED RELATIVELY QUICKLY. |
| 26 | 2021-01-10 | fatigue, chills |
Extreme body aches, chills, joint pain, fatigue. 800mg ibuprofen taken which somewhat relieved symp...
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Extreme body aches, chills, joint pain, fatigue. 800mg ibuprofen taken which somewhat relieved symptoms, but not completely.
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| 26 | 2021-01-10 | fatigue, headache, malaise |
Extreme soreness in arm that night but especially next day Headache/ borderline migraine next day an...
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Extreme soreness in arm that night but especially next day Headache/ borderline migraine next day and continuing for about a week and a half (so far) Mild body aches/ malaise the day after Fatigue next day and for next week and a half (so far) afterwards
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| 26 | 2021-01-10 | headache, fatigue, shortness of breath, chills, weakness |
Had me wait for 15 minutes after vaccine and started having a redness in neck and was really itchy; ...
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Had me wait for 15 minutes after vaccine and started having a redness in neck and was really itchy; whole body big time itchy. My chest - shortness of breath. Gave me a shot of benydryl - 25 mg in my right arm and I went home and itching still didn't go away and I took pill of benydryl. Chills next day; super cold; headache; tired - and I couldn't think straight. Nothing was registering in my head with training at work - felt slow. Went home from took more benydryl. Next morning - pins and needles in back of my head. Went to urgent care (Riverside Urgent Care) and they gave me gave me Vexamethasone - shot it up in my butt and every symptom went away after that shot and I was okay after that.Itching went away after that. Felt weak for about a week afterwards. Went and had second shot yesterday 1/10/2021. They gave me medication with vaccine so I wouldn't get reaction this time. Gave me liquid 25 benydryl beforehand and had me wait 15 mintues and after 15 min they gave me the second dose of vaccine after the injection and they had me wait for 30 minutes. Right away I started getting itchy and they gave me pill form( 2 pills) of Vexamethsone and itching slowly stopped and they sent me home after an hour. Itching slowly went away - later that day. And today I'm okay.
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| 26 | 2021-01-10 | fatigue, fever, chills |
I am currently 20 weeks pregnant. y left arm was really sore after the injection. I had pain under m...
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I am currently 20 weeks pregnant. y left arm was really sore after the injection. I had pain under my left armpit with fever and chills and felt fatigued. My symptoms lasted two days. I slept a lot during the day and day after the injection . I did not get care from a hospital or doctor.
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| 26 | 2021-01-10 | shortness of breath, fatigue, throat pain, throat swelling |
Patient experienced shortness of breath, sensation of throat swelling, fatigue, body aches, and sore...
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Patient experienced shortness of breath, sensation of throat swelling, fatigue, body aches, and sore throat about 1 hour after vaccine was administered at a hospital setting and was seen about 6 hours later a different medical office. These symptoms gradually became worse throughout the day. Patient was given Benadryl 25 mg oral syrup one time and emergency medical services were called to the clinic. Patient was transported to the emergency room by paramedics. Patient was called today by provider for a wellness check and notes shortness of breath and sensation of throat swelling resolved after being treated by paramedics and emergency room providers. Patient states she is overall feeling much better.
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| 26 | 2021-01-10 | shortness of breath |
Patient reported perioral numbness which progressed over 24 hours to include difficulty breathing. P...
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Patient reported perioral numbness which progressed over 24 hours to include difficulty breathing. Patient was transported to the nearest Emergency room for further evaluation/monitoring. Patient was given Benadryl 25mg by mouth x1 dose
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| 26 | 2021-01-10 | respiratory tract congestion, fatigue, headache |
Severe headache, body aches, fatigue, congestion starting approx. 12 hours after vaccination. Sympto...
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Severe headache, body aches, fatigue, congestion starting approx. 12 hours after vaccination. Symptoms subsided within 48 hours.
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| 26 | 2021-01-10 | chills, shortness of breath, headache, fever, fatigue, dizziness |
Within seconds increased heart rate shortness of breath light headedness and dizziness but thought i...
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Within seconds increased heart rate shortness of breath light headedness and dizziness but thought it could have been anxiety. Did not say anything and sat there for the 15 minutes with continued shortness of breath and high rate think it was anxiety. When the time was up I continued to stay at the hospital for an hour due to fear of bad reaction. Started to become extremely nauseous within 30 minutes and loss of appetite. Went to bed and woke up with a terrible headache, body aches, extreme fatigue and a 100.3 degree fever. Slept for 8 hours during the day waking up due to the pain in my body and chills but the symptoms went away by 5 pm the following day of the shot.
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| 26 | 2021-01-10 | headache, throat pain, fever |
Woke up at 1000 with severe body aches, sore neck, sore throat, mild headache, and nausea. Running a...
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Woke up at 1000 with severe body aches, sore neck, sore throat, mild headache, and nausea. Running a mild fever of 99.3F (baseline usually around 96.5-97.0). I took some Tylenol to elevate symptoms.
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| 26 | 2021-01-10 | fever, headache, fatigue | fever, headache, nausea, body aches, fatigue-symptoms resolved |
| 26 | 2021-01-10 | fever | fever, muscle ache, nausea. called in sick to work. |
| 26 | 2021-01-11 | headache, headache | Developed a headache 48-72 hours post vaccine |
| 26 | 2021-01-11 | fever, chills, headache, night sweats | Fevers of 102, chills, night sweats, body aches, headaches, nausea. |
| 26 | 2021-01-11 | shortness of breath | HR 160, shortness of breath. Wheelchaired to ED for further monitoring. |
| 26 | 2021-01-11 | chills, fever | Muscle/joint aches, low grade fever, chills happens every 4 hours. |
| 26 | 2021-01-11 | dizziness, headache | Nausea, Dizzy, Headache |
| 26 | 2021-01-11 | fever | Sore arm low grad fever week later, lymph node on arm pit was swollen and tender |
| 26 | 2021-01-11 | headache, fever, chills, fatigue |
Sore arm low grade fever chills body aches fatigue headache lymph node tenderness on the right side ...
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Sore arm low grade fever chills body aches fatigue headache lymph node tenderness on the right side arm pit
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| 26 | 2021-01-11 | fever | Sore arm low grade fever week later, lymph node on arm pit was swollen and tender |
| 26 | 2021-01-11 | chills, fatigue |
chills, hot flashes, swollen injection site, painful injection site/entire Left arm, body aches, fat...
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chills, hot flashes, swollen injection site, painful injection site/entire Left arm, body aches, fatigue
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| 26 | 2021-01-11 | chills, dizziness, throat pain, headache |
headaches, nausea, body aches, chills, sore throat, fatigue, light headedness approximately 12 hour...
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headaches, nausea, body aches, chills, sore throat, fatigue, light headedness approximately 12 hours after administration which continued for a few days after. Medicated with Ibuprofen to manage pain.
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| 26 | 2021-01-12 | shortness of breath, dizziness |
?Pfizer-BioNTech COVID-19 Vaccine EUA? Symptoms experienced: Lightheaded, Shortness of breath with h...
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?Pfizer-BioNTech COVID-19 Vaccine EUA? Symptoms experienced: Lightheaded, Shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Pt also received diphenhydramine and famotidine in ER
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| 26 | 2021-01-12 | fatigue, sweating |
Became Faint, hypotensive and Diaphoretic. Right arm injection site clear. no redness or swelling. I...
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Became Faint, hypotensive and Diaphoretic. Right arm injection site clear. no redness or swelling. Initial BP 82/53 Pulse rate 147. Ate a granola bar and water. BP take again 124/80 Pulse rate 120. Patient became fatigued. Mom or dad picking up
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| 26 | 2021-01-12 | chills, fever | Fevers, chills, body aches experienced at 0200 on 1/12. Vaccine was received at 1100 on 1/11. |
| 26 | 2021-01-12 | fatigue |
Low grade temperature; myalgias; fatigue; neck pain; injection site tenderness; This is a spontaneou...
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Low grade temperature; myalgias; fatigue; neck pain; injection site tenderness; This is a spontaneous report from a contactable physician (patient herself). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (right arm), on 05Jan2021 at 16:00, at a single dose, for COVID-19 immunization. The patient has no relevant medical history and has no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular (left arm), on 17Dec2020, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 05Jan2021 at 21:00, the patient experienced low-grade temperature, myalgias, fatigue, neck pain, and injection site tenderness. The patient did not receive treatment for the events. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 26 | 2021-01-12 | dizziness, sweating |
Patient presented to clinic RN in observation room 5 minutes post COVID-19 vaccination. Patient visi...
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Patient presented to clinic RN in observation room 5 minutes post COVID-19 vaccination. Patient visibly diaphoretic while sitting in chair and reporting dizziness/feeling like she "is going to faint." Patient walked with 2 RNs to stretcher. Patient was alert, then laid down on stretcher and given water. Emergency response team called and team arrived on unit within 10 minutes. Vitals taken and follow: BP: 94/50 HR: 49, spO2: 100%. Patientt reports low BP and HR at baseline. Vitals recheck: BP: 100/59, HR: 67, spO2: 100%. Patient reporting feeling "back to normal" after a total time of 25 minutes. Denies pain, itching, SOB, difficulty breathing, or dizziness. BG: 109. Emergency rsponse physician cleared patient. Patient walked around clinic with RN prior to exiting. Denied any distress. Independently exited clinic.
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| 26 | 2021-01-12 | sweating, dizziness |
Patient presented to clinic RN in observation room 5 minutes post COVID-19 vaccination. Was visibly ...
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Patient presented to clinic RN in observation room 5 minutes post COVID-19 vaccination. Was visibly diaphoretic while sitting in chair and reporting dizziness/feeling like she "is going to faint." Patient walked with 2 RNs to stretcher. Patient was alert, then laid down on stretcher and given water. Emergency response team was called and team arrived on unit within 10 minutes. Vitals on arrival include BP: 94/50 HR: 49, spO2: 100%. Patient reports low BP and HR at baseline. Vitals recheck: BP: 100/59, HR: 67, spO2: 100%. Patient reporting feeling "back to normal" after total time of 25 minutes. Denies pain, itching, SOB, difficulty breathing, or dizziness. BG: 109. Emergency response physician cleared patient. Patient walked with around with clinic RN prior to leaving. Denies any distress. Independently exited clinic.
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| 26 | 2021-01-12 | dizziness, shortness of breath |
Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms experienced: Lightheaded, shortness of breath with hyp...
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Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms experienced: Lightheaded, shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Patient also received diphenhydramine and famotidine in ER.
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| 26 | 2021-01-12 | dizziness, shortness of breath |
Pfizer-BioNTech COVID-19 Vaccine Symptoms experienced: Lightheaded, shortness of breath with hyperve...
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Pfizer-BioNTech COVID-19 Vaccine Symptoms experienced: Lightheaded, shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Diphenhydramine and famotidine given in ER
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| 26 | 2021-01-12 | chills, headache | Post nasal drip, headaches, chills, hot flashes, and red raised bumps that are raised |
| 26 | 2021-01-12 | migraine | Rash, body aches, migraine |
| 26 | 2021-01-12 | fatigue, headache, dizziness, respiratory tract congestion, sweating, cough |
Vaccine Dose 1 12/17/2020: I received the vaccine and within 5 minutes I experienced dizziness, swea...
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Vaccine Dose 1 12/17/2020: I received the vaccine and within 5 minutes I experienced dizziness, sweating and was flushed. After 15 minutes the dizziness did not go away and my vitals were checked. My BP was elevated 136/106 and HR 105, I was taken to the ED after repeated BP readings continued to show increased diastolic pressure. I was observed in ED for a period of almost 6 hours. Within an 1.5 hours after receiving vaccine, I had right neck stiffness, headache, and some weakness to the right side as well along with the dizziness and high BP. I received a 1L bolus of NS, 2 doses of antivert, Toradol, Zofran and Lidocaine patches. 24 hours after receiving vaccines, I was having pain at the insertion site, headache, neck stiffness and occasional dizziness. After 36 hours my symptoms subsided and I felt back to baseline. Vaccine Dose 2 01/07/2020: I received my second dose of the COVID vaccine and within the first 15 minutes I experienced dizziness, nausea, flashing spots in vision, right sided weakness, increased BP & HR, redness and sweating. After 30 minutes the symptoms did not subsided and I was taken to the ED. An hour after receiving the vaccine, I had right sided weakness to arm and legs with no numbness, dizziness, R. sided neck stiffness, right sided headache, nausea and flashing spots. I received Ativan, Reglan, Tylenol, Toradol and Benadryl in the ED. I was in ED for 3.5 hours after vaccines was administered and was able to ambulate to the car independently. 16 hours after receiving vaccine, I had muscle weakness to bilateral lower extremities and was unable to ambulate independently along with dizziness, headache, arm soreness, cough, congestion, neck stiffness and fatigue. 36 hours after vaccine I regained movement to bilateral lower extremities however still was experiencing fatigue, occasional dizziness, intermittent neck stiffness and headache, body aches and some shakiness to lower extremities. 55 hours after receiving vaccine I was still fatigued and experiencing intermittent headache and neck stiffness. 72 hours after vaccine I was still fatigued and having occasional headaches but feeling much much better from initial reaction. 96 hours after receiving vaccine I experienced occasional headache, woke up with neck stiffness and was finally able to drive a car without any dizziness or nausea. 144 hours after vaccine I am not completely back to baseline still fatigued with occasional neck stiffness and headache but able to go back to work.
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| 26 | 2021-01-12 | body temperature increased, cough |
Within fifteen minutes of the vaccine became itchy all over and pharmacy administered Benadryl. Thi...
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Within fifteen minutes of the vaccine became itchy all over and pharmacy administered Benadryl. This morning she developed a temp of 99.4, shaking all over, chest hurts, cough and aching
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| 26 | 2021-01-12 | respiratory tract congestion, fever | congestion, loss of taste smell and low grade temp, COVID positive |
| 26 | 2021-01-12 | fever | fever, body aches. called in sick to work. |
| 26 | 2021-01-12 | fever, chills, shortness of breath | fever, chill, sob, chest pressure, tachycardia |
| 26 | 2021-01-12 | nerve pain |
first dose on 18Dec2020/second dose on 05Jan2021; injection arm is hurting a lot.; It feels like ner...
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first dose on 18Dec2020/second dose on 05Jan2021; injection arm is hurting a lot.; It feels like nerve pain from my armpit to my fingers (left arm).; my lymph node in my left armpit is swollen because it feels like theres a golf ball pushing; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: el1284), intramuscular on 05Jan2021 at 15:30 at single dose in left arm for covid-19 immunization. Medical history included tachycardia, IBS (Irritable bowel syndrome), and allergies: Sulfa drugs. Concomitant medication included nortriptyline, buspirone, lubiprostone (AMITIZA), probiotics, diltiazem. The patient previously received the first dose bnt162b2 (batch/lot number: eh9899) in left arm on 18Dec2020 for covid-19 immunization. The patient reported that her injection arm was hurting a lot. It felt like nerve pain from her armpit to her fingers (left arm). She believed her lymph node in her left armpit was swollen because it felt like there's a golf ball pushing into her armpit. These events happened on 06Jan2021 at 01:00. These events were reported as non-serious by reporter. The patient did not receive treatment for these events. The outcome of these events was not resolved. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination.
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| 26 | 2021-01-12 | fever, headache, chills | headache, fever, chills and pain in arm |
| 26 | 2021-01-13 | dizziness | 10 ' after vaccine, developed roof mouth tingling , dizziness , tachycardia and Left arm tingling . |
| 26 | 2021-01-13 | fever, chills, headache |
About 16 hours after second dose of the Pfizer COVID-19 vaccination: - Fever of 101-102F - Chills - ...
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About 16 hours after second dose of the Pfizer COVID-19 vaccination: - Fever of 101-102F - Chills - Body aches - Joint aches - Headache About 40 hours after time of vaccine: - Fainting spells x2 (shakiness, blurry vision, ringing in ears, loss of balance)
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| 26 | 2021-01-13 | fever | Body aches and Fever |
| 26 | 2021-01-13 | fever | Fever (101.2), significant body aches, nausea |
| 26 | 2021-01-13 | fever | Fever and Body Aches |
| 26 | 2021-01-13 | fever |
Fever up to 102 onset 24 hours after vaccine, continued currently now approaching 48h since vaccine....
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Fever up to 102 onset 24 hours after vaccine, continued currently now approaching 48h since vaccine. Treated with acetaminophen and ibuprofen with relief, but still remain febrile.
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| 26 | 2021-01-13 | headache, chills, fever | Fever, Chills, Nausea w/o vomiting, Muscle Aches, Headache, and elevated blood sugars. |
| 26 | 2021-01-13 | headache, fever, chills | Fever, chills, body aches, nausea, headache |
| 26 | 2021-01-13 | fatigue, headache, chills |
I did okay with the first dose only experienced site pain and fatigue. This second dose has not been...
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I did okay with the first dose only experienced site pain and fatigue. This second dose has not been pleasant: I am experiencing injection site pain, headaches, body aches, chills, and back pain.
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| 26 | 2021-01-13 | fatigue | I was just overly fatigued. I slept for 24 hours. I didn't feel achy or anything else. |
| 26 | 2021-01-13 | dizziness |
Patient reported feeling like her heart was racing approximately 5 minutes after receiving the injec...
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Patient reported feeling like her heart was racing approximately 5 minutes after receiving the injection and feeling dizzy as well. Heart rate and blood pressure were elevated with normal pulse ox. After approximately an hour pulse ox remained normal, but heart rate and blood pressure remained elevated. Patient was referred to emergency department for further evaluation.
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| 26 | 2021-01-13 | cough, shortness of breath |
Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observa...
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Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observation area at this time. At 1530, EE returned to vaccination room to alert staff of her reaction. Upon hearing her new onset cough, an assessment was performed immediately. Reported tingling and swelling of her lips, cough, minor difficulty breathing with mask on, facial flushing and feeling hot, and severe pruritus, especially on the scalp. 50 mg IM Benadryl administered and was taken to ED via wheelchair which is 7 minutes away. Epi Pen administered in ED and admitted overnight for observation d/t irregular HR and ST depression on monitor.
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| 26 | 2021-01-13 | fever, fatigue |
Starting the day after the vaccine she had fatigue, fever, and a swollen and painful axillary lymph ...
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Starting the day after the vaccine she had fatigue, fever, and a swollen and painful axillary lymph node on her left underam.
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| 26 | 2021-01-13 | shortness of breath | Systemic: Nausea, Systemic: shortness of breath |
| 26 | 2021-01-13 | weakness | Systemic: shaky, weak, tachycardic, gave O2, pt has heart issues already |
| 26 | 2021-01-14 | sweating, nasopharyngitis, body temperature increased, chills |
12 hours after administration, woken up from sleep by tingling, throbbing in lower legs. Described a...
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12 hours after administration, woken up from sleep by tingling, throbbing in lower legs. Described as a nerve and muscle ache/throb, or "growing pains"/RLS symptoms. Put on compression socks which helped, but still too uncomfortable to sleep. Was able to sleep after taking ibuprofen 800mg and drinking water. 6 hours after the ibuprofen was administered, pain returned in lower legs as well as neck/ears with body temperature swings (cold, teeth chattering to sweating uncontrollably in a few minutes). After 1 hour of trying to sleep but failing, put compression socks back on. Temperature rose to 100-100.2 F, chills causing whole body to shake under multiple blankets. Tingling/muscle pains extremely uncomfortable and unable to rest, took another ibuprofen 800mg and water and was able to sleep. Tingling and muscle pains have continued as soon as ibuprofen wears off and come back more intense each time, most notably in the lower legs and near ears/neck and elbow of arm administered in (similar to "tennis elbow," assumed to be provoked by inflammation, happened with first dose).
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| 26 | 2021-01-14 | chills, fatigue, fever, headache |
2 episodes of vomiting; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swe...
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2 episodes of vomiting; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Fever of 100.0; Chills; Extreme fatigue; Headache; Muscle aches; Nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received 1st dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm on 18Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included covid-19 from Oct2020 to an unknown date. No known allergies. The patient was not pregnant. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). No other vaccine received in four weeks. The patient experienced fever of 100.0, chills, extreme fatigue, headache, muscle aches , nausea and pain/redness/tenderness/swelling injection site on 19Dec2020 13:00, 2 episodes of vomiting on 19Dec2020 23:45. Patient received tylenol as treatment. No COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 100.0 on 19Dec2020, Covid test: positive in Oct2020. The outcome of fever of 100.0, chills, headache, muscle aches was recovered on 20Dec2020, nausea was recovered on 21Dec2020, extreme fatigue and pain/redness/tenderness/swelling injection site was recovered on 22Dec2020, 2 episodes of vomiting was recovered on an unspecified date. This case was reported as non-serious.
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| 26 | 2021-01-14 | dizziness |
24hrs after shot felt fine I til about 30hrs then felt lightheaded, dizzy, and nauseous. Vomited on...
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24hrs after shot felt fine I til about 30hrs then felt lightheaded, dizzy, and nauseous. Vomited once. The next day (~42hrs after shot) spiked fever 101.2 and continued to feel dizzy but less nauseous. Took 800mg Motrin at 5am on 1/15/21
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| 26 | 2021-01-14 | fever, chills |
Injection site redness; rash on arm near injection site; fever in arm; chills; nausea; This is a spo...
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Injection site redness; rash on arm near injection site; fever in arm; chills; nausea; This is a spontaneous report from a contactable other health care professional. A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EJ1686), intramuscular on 31Dec2020 07:30 at single dose at arm left for COVID-19 immunization. Medical history included GERD, ovarian cysts, obesity, and anxiety. Concomitant medications included fluoxetine, omeprazole, and folic acid. On 11Jan2021 07:00, the patient experienced Injection site redness, rash on arm near injection site, fever in arm, chills, nausea. The patient did not receive treatment for the events. The outcome of the events was recovering.
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| 26 | 2021-01-14 | fatigue |
Patient developed angioedema of her eyelids after COVID-19 vaccination. She received her Covid vacc...
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Patient developed angioedema of her eyelids after COVID-19 vaccination. She received her Covid vaccine on 1/10/2021 at 11:30 AM. She received the Pfizer vaccine. She works at a nursing home. She had some fatigue and tiredness during the day but woke up on the second day without any symptoms. On 1/30/2021, she developed bilateral eyelid swelling. The swelling is mild to moderate intensity involving the upper and lower eyelids bilaterally with a prickly burning sensation associated with pruritus. The reaction lasted less than a day and resolved without any skin desquamation, scarring or bruising. She denies any hives anywhere else. She does not have a large local reaction at the injection site. She denies respiratory complaints, GI symptoms, lightheadedness, loss of consciousness, wheezing, swelling of her throat or other symptoms consistent with anaphylaxis. She used Benadryl with significant improvement. She had a significant reaction after influenza vaccination consisting of swelling of her face and her eyelids with development of dry patches bilaterally within 2 days, resolving with skin desquamation. The reaction lasted for 1 week. She received her influenza vaccination in October 20, 2020. She was seen in our office in 2012 for bilateral eyelid angioedema with associated urticaria shortly after swimming in the pool. She was given oral antihistamines ?Zyrtec once daily? with significant improvement as well as prevention of this reaction. She has not had this reaction for more than 6 years.
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| 26 | 2021-01-14 | fever, headache, fatigue, dizziness, chills |
Severe headache lasting 2-3 days; fever; chills; light-headedness; Fatigue; This is a spontaneous re...
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Severe headache lasting 2-3 days; fever; chills; light-headedness; Fatigue; This is a spontaneous report from a contactable health care professional, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730), intramuscular in the left arm on 23Dec2020 at 08:00 AM (at the age of 26-year-old) as a single dose for COVID-19 immunization. Medical history was none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 17:00 PM, the patient experienced severe headache lasting 2-3 days, fever, chills, light-headedness, and fatigue. The patient did not receive any treatment for the severe headache lasting 2-3 days, fever, chills, light-headedness, and fatigue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache lasting 2-3 days, fever, chills, light-headedness, and fatigue was recovered.
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| 26 | 2021-01-14 | fever, chills, dizziness, headache |
Symptoms starts 9am with headache. For 3 times panadol q 4 hours 500mg. At 8pm start fever (40.2 C)...
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Symptoms starts 9am with headache. For 3 times panadol q 4 hours 500mg. At 8pm start fever (40.2 C), nauseas, dizzines, shaking chills and lost smell. Vomiting starts at 9:25 pm end 2:00 am. 01/08/2021 at 2:26 am visit Emergency Room, in clinic fainted and present high blood pressure 155/99. In hospital medication administred: Zofran, pepcid, .45 NSS and Phenergan IM at 01-08-2021.
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| 26 | 2021-01-14 | fever | fever, vomiting. called in sick to work. |
| 26 | 2021-01-14 | headache, fever, fatigue |
low grade fever, 99 degrees Fahrenheit starting the day following injection, lasting 1 day; Fatigue,...
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low grade fever, 99 degrees Fahrenheit starting the day following injection, lasting 1 day; Fatigue, moderate, lasting 1 day; Headache, moderate, lasting 1 day; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown) at the hospital, via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 28Dec2020, the patient experienced fatigue, moderate, lasting 1 day, headache, moderate, lasting 1 day, and low grade fever, 99 degrees Fahrenheit starting the day following injection, lasting 1 day. The events were considered as non-serious. No treatment was received for the events. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. It was also unknown if patient has been tested for COVID-19 since the vaccination. The events recovered on 29Dec2020. Information about batch/lot number has been requested.
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| 26 | 2021-01-15 | chills, fatigue, fever, throat pain, headache |
1/13 AT 2AM AWOKE WITH CHILLS, FEVERISH (t99) HEADACHE FROM TOP OF HEAD DOWN TO POSTERIOR NECK, SORE...
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1/13 AT 2AM AWOKE WITH CHILLS, FEVERISH (t99) HEADACHE FROM TOP OF HEAD DOWN TO POSTERIOR NECK, SORE THROAT, FATIGUE, MYALGIA AND ARTHRALGIA Did not work on 1/14/21- by 1/14/21 afternoon improved
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| 26 | 2021-01-15 | fever, fatigue |
Diarrhea, nausea, body aches, stiff neck, low grade fever , fatigue . Happened 6 hours after injecti...
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Diarrhea, nausea, body aches, stiff neck, low grade fever , fatigue . Happened 6 hours after injection ( this happened when I got my first one too)
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| 26 | 2021-01-15 | dizziness, fatigue | Fatigue, dizziness, confusion, tremors, brain fog, irregular menstrual period |
| 26 | 2021-01-16 | chills, fever |
I received the vaccine at 11:56AM on 1/15/2021. L arm injection site pain/tenderness which increased...
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I received the vaccine at 11:56AM on 1/15/2021. L arm injection site pain/tenderness which increased over the course of two days. At approximately 12:30AM on 1/16/2021, extreme nausea, vomiting, fever, chills, and muscle aches began. During the day on 1/16/2021 severe joint pain (specifically bilateral knees and hips, and spine) occurred, somewhat relieved by Tylenol. On 1/17/2021 at 1:15AM, intense nausea, vomiting, and fever occurred again. As of 9:15AM on 1/17/2021, body aches and joint pain are returning and nausea is persistent.
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| 26 | 2021-01-16 | headache, fever, chills | Low grade fever, chills, body aches, headache, arm soreness |
| 26 | 2021-01-17 | skin warm |
8 days after her first Covid vaccination, pt developed arm redness and tenderness at the injection s...
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8 days after her first Covid vaccination, pt developed arm redness and tenderness at the injection site. Exam notable for 7cm region of erythema, with central induration. region is warm, mildly tender to palpation. no severe swelling. also tender Left axillary adenopathy. no fever, chills. no systemic systems. Pt very well appearing. presentation concerning for cellulitis.
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| 26 | 2021-01-17 | dizziness, shortness of breath | Dizzy, Shortness of breath, Tachycardia. |
| 26 | 2021-01-17 | somnolence, fever, fatigue |
I got the shot around 4:30PM on Friday and woke up in the middle of the night that night with a feve...
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I got the shot around 4:30PM on Friday and woke up in the middle of the night that night with a fever (100.5) and aches. I had both symptoms all through Saturday as well. I was also very tired and slept most of the day Saturday. When I woke up on Sunday I felt totally fine again.
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| 26 | 2021-01-17 | migraine, chills, headache, fever |
Tachycardia up to 150 resting; Nausea; Vomiting; Diarrhea; Headache; Migraine; Body aches; Chills; F...
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Tachycardia up to 150 resting; Nausea; Vomiting; Diarrhea; Headache; Migraine; Body aches; Chills; Fever up to 102; This is a spontaneous report from a contactable nurse (patient). This 26-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248), intramuscular on 08Jan2021 at 07:45 AM at single dose on right arm for COVID-19 immunisation. Medical history included anxiety and depression. No known allergies. Concomitant medication included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), diphenhydramine hydrochloride (ZZZQUIL). No other-vaccine-in-four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730), intramuscular on 22Dec2020 at 08:00 PM on right arm for COVID-19 immunisation. The patient experienced tachycardia up to 150 resting, nausea, vomiting, diarrhea, headache, migraine, body aches, chills and fever up to 102. Symptom onset around 7PM on 08Jan2021 and stopped around 12PM 09Jan2021 except for headache which was still persisting as of 9PM 09Jan2021. No treatment was received for the events. The outcome of headache was not recovered. The outcome of other events was recovered on 09Jan2021 at 12PM. The patient did not have COVID-prior-vaccination. The patient did not have COVID tested post vaccination.; Sender's Comments: The reported tachycardia was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 26 | 2021-01-19 | headache, chills, fever |
At 1 AM on 1/19/21, I awoke with chills, a fever of 101, neck pain, muscle pain, joint pain, and a s...
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At 1 AM on 1/19/21, I awoke with chills, a fever of 101, neck pain, muscle pain, joint pain, and a severe headache. This persisted throughout the night and I did not sleep. Took 1000 mg of Acetaminophen at 5:30 and slept until 7 AM. By 8 AM, my temperature was back down to 98 F. Took 500 mg of Acetaminophen at 10 AM with food. Headache, muscle pain, and joint pain persisted. Moderate to severe chest pain began 15 mins after eating at 4 PM. Waited 30 mins to see if it resolved; it did not. Went to the urgent care. Chest x-ray and EKG was performed, no issues found. Was diagnosed with costochondritis and was given a steroid shot and ibuprofen, which reduced the pain significantly within 30 mins later.
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| 26 | 2021-01-19 | fever, dizziness, chills | Dizziness, vomiting, fever, chills |
| 26 | 2021-01-19 | fatigue, chills | Fatigue, body aches, injection site pain, chills |
| 26 | 2021-01-19 | chills, fever | Fever (100.4), chills, nausea and severe joint and body aches |
| 26 | 2021-01-19 | headache, fatigue | Headache, fatigue, body ache, injection sore soreness |
| 26 | 2021-01-19 | headache, fever, fatigue |
Headache; Fever up to 100.5; Extreme fatigue; Muscle aches; Nausea; Lack of appetite; Immediate arm ...
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Headache; Fever up to 100.5; Extreme fatigue; Muscle aches; Nausea; Lack of appetite; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; This is a spontaneous report from a contactable Nurse. A 26-year-old female patient patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246) intramuscular, on 08Jan2021 at 16:00 on left arm at single dose for COVID-19 immunization. Relevant medical history included that patient had a Covid diagnosis on early October. Vaccination history included first dose of BNT162B2 (lot number: EK5730) on 18Dec2020 at 10:00 AM, Intramuscular on Left arm .Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). The patient was not pregnant. On 08Jan2021 at 16:00 the patient experienced Immediate arm pain - swelling, tender to touch. On the same day at 22:00 the patient experienced Fever up to 100.5, extreme fatigue, muscle aches, nausea and lack of appetite. Treatment received included Tylenol. The patient recovered from Immediate arm pain - swelling, tender to touch on an unspecified date, from other reported events, recovered on 10Jan2021.
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| 26 | 2021-01-19 | skin warm |
Hives noted the following morning that were described as red, hot and itchy. Located on chest, head...
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Hives noted the following morning that were described as red, hot and itchy. Located on chest, head, hands and arms, side of right hip. Used Claritin and ice packs with some relief. Also experienced numbness on her left shoulder and left chest to navel which subsided by mid day. No breathing issues or any additional signs or symptoms.
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| 26 | 2021-01-19 | headache, chills |
I experienced chest pain or discomfort intermittently mid-day and afternoon. It subsided after this ...
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I experienced chest pain or discomfort intermittently mid-day and afternoon. It subsided after this point. The night of 1/13/21, I fell asleep but awoke multiple times cold. I experienced the chills through about midnight. The next morning, 1/14/21, I woke up with a headache at about 5:30am. I took a dose of Aleve and the symptoms had subsided by about 6:30am
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| 26 | 2021-01-19 | chills, fatigue, throat pain, fever |
Jan 11th- by 11PM felt fatigue, muscle aches, febrile, nauseous, and chills. Jan 12th- Fatigue, sor...
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Jan 11th- by 11PM felt fatigue, muscle aches, febrile, nauseous, and chills. Jan 12th- Fatigue, soreness at injection site, and chills. Jan 13th- chills and fatigue. Jan 16th- febrile, body aches, and chills Jan 17th- febrile, fatigue, body aches and chills. Jan 18th- febrile, fatigue, body aches and chills Jan 19th- febrile, fatigue, body aches, chills, sore throat, left ear pain and nausea. Jan 20th- sore throat, body aches, fatigue, hives
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| 26 | 2021-01-19 | headache, cough, dizziness, fatigue |
My hip feels sore and achy, but I only feel slight spasms when I put weight on it.; With the second ...
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My hip feels sore and achy, but I only feel slight spasms when I put weight on it.; With the second dose I woke up the next morning feeling very fatigued; dry cough; dizziness/slight dizziness; an aching headache that felt heavy (4/10 pain)/slight headache (2/10 pain); muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; This is a spontaneous report from a contactable healthcare professional (patient). This 26-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284) on 08Jan2021 at 16:45, in left arm, for COVID-19 immunization. Medical history included GERD, IBS, gastritis, asthma, anxiety/depression. The patient had known allergies to penicillin, cefalexin monohydrate (KEFLEX), lactose. The first dose of BNT162B2 vaccine (lot EH 9899) was given on 18Dec2020 at 16:00, in left arm and the patient experienced a sore throat for 3 hours, mild difficulty breathing, mild fever (99.1), fatigue and throbbing headache (6/10 pain). No other vaccine was given in 4 weeks. Concomitant medications included albuterol, pantoprazole, fluoxetine, cholestyramine. After the second dose of vaccine, the patient woke up on 09Jan2021 at 06:30 feeling very fatigued with a dry cough, dizziness, an aching headache that felt heavy (4/10 pain). Later in the day she started having muscle spasms in her hips, knees, shoulders and jaw (7/10 pain). These spasms felt like someone was stabbing her with an electric knife. Over the day the spasms settled into her right hip and knee. Paracetamol (TYLENOL) helped managing the pain and sleep helped the pain getting better. On 10Jan2021 the patient woke up with a slight headache (2/10 pain) and slight dizziness. Her hip felt sore and achy, but she only felt slight spasms when she put weight on it. The events were resolving at the time of report.
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| 26 | 2021-01-19 | headache, fatigue | Nausea, joint pain, headache, fatigue |
| 26 | 2021-01-19 | sweating, dizziness |
Pt received the vaccine dose 2 and was sitting in the observation area when she stated that she was ...
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Pt received the vaccine dose 2 and was sitting in the observation area when she stated that she was feeling lightheaded and felt like she was going to pass out. This reaction occurred within 15 minutes of receiving the vaccine. Pt was pale, sweaty, diaphoretic, hypotensive and had bradycardia. Pt's systolic BP was in the 60s and her diastolic was in the 30s. Pt was offered food but refused. Pt was immediately brought to the ER where her care was transferred to an ER nurse.
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| 26 | 2021-01-19 | dizziness |
Started with nausea, racing heart, and dizziness. Within a few minutes scratchy throat and Epi was ...
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Started with nausea, racing heart, and dizziness. Within a few minutes scratchy throat and Epi was administered along with O2 at that time. Sent to ER.
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| 26 | 2021-01-19 | chills, headache, fatigue |
Symptoms within first 6-24 hours of receiving 2nd dose: moderate pain at injection site, body/muscle...
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Symptoms within first 6-24 hours of receiving 2nd dose: moderate pain at injection site, body/muscle aches, chills, intermittent headache and fatigue
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| 26 | 2021-01-19 | dizziness, sweating |
pt started feeling light headed and sweaty within 5 min of vaccination. pt didn't report symptoms un...
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pt started feeling light headed and sweaty within 5 min of vaccination. pt didn't report symptoms until 2 hours later, when she was given 25 mg of diphenhydramine. then she was being monitored every 60 min for changes
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| 26 | 2021-01-20 | sweating, influenza like illness, fever, headache, fatigue, chills |
headache; sweating; severe chills; fatigue/more fatigue; fever 100.6 F/fever peaked at 102 F/fever d...
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headache; sweating; severe chills; fatigue/more fatigue; fever 100.6 F/fever peaked at 102 F/fever down to 100.4; felt like had the flu.; This is a spontaneous report from a contactable pharmacist (patient). A 26-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= EK4176), via an unspecified route of administration at left arm on 08Jan2021 07:45 AM at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient's medical history included Deep vein thrombosis (DVT) from 2017. Concomitant medication included naproxen, doxycycline and women's multivitamin. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK5730) via an unspecified route of administration at left arm on 18Dec2020 09:15 PM at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 14 hours after second dose, the patient experienced severe chills and fatigue, fever 100.6 F, felt like had the flu. 16 hours fever peaked at 102 F, 26 hours, chills gone, fever down to 100.4, new onset headache and sweating, more fatigue. Onset date of events chills, fatigue, fever and felt like flu was provided on 08Jan2021 at time of 08:00 PM. Onset date of events headache and sweating was provided 09Jan2021 09:45 AM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered in Jan2021.
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| 26 | 2021-01-20 | headache, fatigue, fever, throat pain, shortness of breath |
sore throat; mild difficulty breathing; mild fever (99.1); fatigue; throbbing headache(6/10 pain); T...
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sore throat; mild difficulty breathing; mild fever (99.1); fatigue; throbbing headache(6/10 pain); This is a spontaneous report from a contactable healthcare professional. A non-pregnant 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH 9899), via an unspecified route of administration in the left arm on 18Dec2020 16:00 at a single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), irritable bowel syndrome (IBS), gastritis, asthma, anxiety/depression, allergies: penicillin. Concomitant medication included salbutamol (ALBUTEROL HFA), pantoprazole (MANUFACTURER UNKNOWN), fluoxetine (MANUFACTURER UNKNOWN), cholestyramine (MANUFACTURER UNKNOWN). The patient previously took cefalexin monohydrate (KEFLEX) and lactose (MANUFACTURER UNKNOWN) and experienced allergies. On 18Dec2020, the patient experienced a sore throat, mild difficulty breathing, mild fever (99.1), fatigue and throbbing headache (6/10 pain). Clinical details were reported as follows: On 18Dec2020, the patient had a sore throat and mild difficulty breathing. The patient took albuterol, which helped a little. The patient had a mild fever (99.1) for two days after the shot, as well as fatigue, and a throbbing headache (6/10 pain) for a week and a half. Acetaminophen (TYLENOL) helped manage the pain, and sleep helped the pain get better. The patient underwent lab tests and procedures on 18Dec2020 which included pain: 6/10 and body temperature: 99.1. The clinical outcome of the events was recovering.
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| 26 | 2021-01-21 | dizziness, headache, fatigue, cold sweat, chills |
3 hours following vaccine: nausea, dizziness, and irritability 6 hours following vaccine: previous s...
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3 hours following vaccine: nausea, dizziness, and irritability 6 hours following vaccine: previous symptoms + headache (5 out of 10) and cold sweats 8 hours following vaccine: previous symptoms + widespread body aches (6 out of 10) Restless sleep punctuated by waking up with cold sweats or overheating. 24 hours following vaccine: previous symptoms persist. Headache and body aches have worsened in severity. Unable to work for the morning but was able to go in the afternoon for a short time period. Lower body aches are particularly severe. Fatigue is noticeable. Mental health conditions have worsened but that may be due to lack of sleep. 30 hours following the vaccine: chills, nausea, and dizziness have dissipated completely. They were slowly improving throughout the day. Body aches and headache still severe but lessened with marijuana use. 48 hours following the vaccine: all symptom seemed to have subsided during the night. Sleep was much better quality. Only remaining symptom is an ache on the right side of my chest towards my ribs.
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| 26 | 2021-01-21 | fatigue, fever | Fever of 102, myalgia, extreme fatigue lasting 36 hours |
| 26 | 2021-01-21 | nasal congestion, headache, shortness of breath, chills, fever |
Fever, chills, cough, shortness of breath, HA, nasal congestion. Started about 2 days after immuniza...
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Fever, chills, cough, shortness of breath, HA, nasal congestion. Started about 2 days after immunization and lasted about one week.
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| 26 | 2021-01-21 | influenza like illness, fatigue, chills, fever |
First, flu-like symptoms (body aches, chills, fever, fatigue), then progressive tingling associated ...
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First, flu-like symptoms (body aches, chills, fever, fatigue), then progressive tingling associated with numbness and weakness of the Left Arm, Left Leg, Left side of the face.
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| 26 | 2021-01-24 | headache, fatigue, sweating, chills, dehydration |
Dose Number:1/ Date of start of drug:22Dec2020 / Dose Number:2/ Date of start of drug: 08Jan2021; Se...
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Dose Number:1/ Date of start of drug:22Dec2020 / Dose Number:2/ Date of start of drug: 08Jan2021; Serious chills to the point of physical shaking; serious chills to the point of physical shaking; Nausea; Vomiting; Dry heaving; Significant body aches, especially pronounced in lower back region occurred; Significant body aches, especially pronounced in lower back region occurred; Headache; Having sweats; Possible fever (didn't have thermometer to accurately verify this though); My average HR is usually 70's. For about 36 hours, it ran 100-130's; Dehydration; Feeling fatigued/Excessive fatigue; Had some general arm soreness; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EJ 1686, unknown expiration), intramuscular in right arm on 08Jan2021 at 13:30 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ 1685, unknown expiration) via intramuscular in right arm on 22Dec2020 at 12:30 PM for COVID-19 immunization in a hospital. Concomitant medications included ibuprofen (MOTRIN) as needed and unspecified birth control. The patient has no known allergies. The patient started feeling fatigued about 1900 hours (07:00 PM) on 08Jan2021 and only had some general arm soreness. She woke up on 09Jan2021, with serious chills to the point of physical shaking; nausea started soon after and around 0300, began vomiting and dry heaving. The patient also experienced significant body aches, especially pronounced in lower back region occurred. Headache also present at this time (09Jan2021). She began having sweats and possible fever (didn't have thermometer to accurately verify this though). The patient's average HR is usually 70s. For about 36 hours (09Jan2021), it ran 100-130s. Vomiting episodes continued and for all of 09Jan2021, the patient did absolutely nothing. The patient described her body ached like it had been beaten by a baseball bat. On 10Jan2021, her HR at rest back in 70s, but with minimal exertion, will go to 110-120s. She had to call out of work from 11Jan2021 and 12Jan2021 due to continued nausea, dehydration and excessive fatigue. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient's symptoms still persisting at the time she is reporting this event. The patient did not receive treatment for the events. The outcome of the event "having sweats" was unknown, while the patient is recovering for the remaining events.; Sender's Comments: The reported serious chill was likely related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship and known safety profile of this product.
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| 26 | 2021-01-24 | night sweats, fever, headache, fatigue, chills |
Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Feve...
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Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; This is a spontaneous report from a contactable physician (patient). A 26-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), intramuscular (vaccine location: Left arm) on 11Jan2021 09:30 for COVID-19 immunization. Facility type vaccine: Hospital. The patient had no medical history. The patient was not pregnant. The patient had no known allergies. The patient's had no concomitant medications. There had been no other vaccine in four weeks. There were no other medications in two weeks. The patient had no prior covid vaccination. The patient experienced fever, chills, night sweats, fatigue, and headache on 11Jan2021 22:00. The patient has not been tested for covid post vaccination. No treatment was provided. The outcome of the events was not recovered. Information on the Batch/Lot number has been requested.
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| 26 | 2021-01-24 | nerve pain |
Nerve pain from right upper arm to fingers; This is a spontaneous report from a contactable nurse (p...
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Nerve pain from right upper arm to fingers; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at 11:00AM 12Jan2021 at right arm for COVID-19 immunisation. The first dose was received on 23Dec2020 10:30 AM at right arm. The patient had no medical history, no known allergies and had no Covid-19 before vaccination. The patient had not received other medications in two weeks and no vaccine received in four weeks. At 11:15 AM after the second dose, the patient experienced nerve pain from right upper arm to fingers. Pain was with usage of hand and fingers. Patient had not received treatment for the event. The patient had not tested after vaccination. The event was resolving at the time of reporting. The reporter considered that the event was non-serious. No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
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| 26 | 2021-01-24 | skin warm, migraine, weakness, headache |
Within 24 hours of getting my 2nd COVID vaccine, I began to feel weak and achy. My neck and face got...
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Within 24 hours of getting my 2nd COVID vaccine, I began to feel weak and achy. My neck and face got really hot while the rest of my body stayed cold. A small headache began to turn into a migraine. During the night, my body began to hurt beyond achy causing me to toss and turn. When I woke up in the morning, I couldn't stand even the littlest of pressure placed on my body. For example, my cat jumped on my leg and it felt like someone wacked me with a baseball bat because of how sensitive my body was. The only treatment used for myself during this time was Tylenol. It helped with the head aches. Overall, it took me about three nights to actually feel ok again.
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| 26 | 2021-01-25 | chills |
Approximately 12 hours after the administration of the second COVID19 Pfizer vaccine, I experienced ...
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Approximately 12 hours after the administration of the second COVID19 Pfizer vaccine, I experienced chills and myalgia through the night. I did not improve when I woke up on 01/25. The chills and myalgia worsened and were complicated by vomiting without blood. I called off sick from work and took 3 Aleve tablets. I went back to sleep with improvement in symptoms approximately 6 hours later, with only mild myalgias and a very sore L. arm. Symptoms completely resolved by the morning of 01/26.
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| 26 | 2021-01-25 | fever, chills |
Chills; Body aches; Fevers; This is a spontaneous report from a contactable pharmacist. A 26-year-ol...
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Chills; Body aches; Fevers; This is a spontaneous report from a contactable pharmacist. A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported), intramuscularly on the left arm on 11Jan2021 (10:45) at a single dose for COVID-19 immunization at the hospital. Medical history included hypothyroidism and allergy to sulfa drugs. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported), intramuscularly on the left arm on 21Dec2020 (when the patient was 26 years old) for COVID-19 immunization. On 12Jan2021 (02:00), the patient had fevers, chills and body aches. The patient had received an unspecified over-the-counter (OTC) pain reliever and an unspecified ointment as treatment for the reported events. The outcome of the events, 'fevers', 'chills' and 'body aches', was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.
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| 26 | 2021-01-25 | headache, fever |
Fever of 101.5; headache; body aches; maternal exposure 5 week gestation period; maternal exposure 5...
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Fever of 101.5; headache; body aches; maternal exposure 5 week gestation period; maternal exposure 5 week gestation period; maternal exposure 5 week gestation period; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular at left arm on 06Jan2021 at 12:45 at single dose for COVID-19 immunization. The patient medical history included known allergies to sulfa medications from an unknown date and unknown if ongoing. The patient's concomitant medication included cholecalciferol (D3), cyanocobalamin (B12-VITAMIN), ascorbic acid, beta-carotene, calcium sulfate, cholecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. The patient reported she was pregnant at the time of vaccination. She was at 5 weeks gestational period; last menstrual date was 01Dec2020 and will be due to deliver on 06Sep2021. On 07Jan2020 at 6.00, the patient experienced fever of 101.5 F, headache and body aches. The patient outcome of the events was recovered.
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| 26 | 2021-01-25 | fever, headache, chills |
Fever; cold chills; Hot flashes; Nausea; Headache; increase body pain; This is a spontaneous report ...
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Fever; cold chills; Hot flashes; Nausea; Headache; increase body pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), intramuscularly on the left arm on 04Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included liver failure, mononucleosis, gallbladder disease, mitral regurgitation of the heart and fibromyalgia; patient had no known allergies. Concomitant medications were not reported. Patient did not have COVID prior vaccination, no other vaccine was given in four weeks prior and patient did not receive other medications within two weeks of the vaccine. The vaccine was given at a nursing home/senior living facility. On 04Jan2021, the patient experienced fever, cold chills, hot flashes, nausea, headache and increased body pain. Moderate side effects were also reported from 05Jan2021 to 09Jan2021. No treatment was given for the events. The patient underwent lab tests and procedures which included nasal swab COVID test: negative on 04Jan2021 and saliva swab test for COVID: pending result on 11Jan2021. Outcome of the events was recovering. Information on the lot/ batch number has been requested.
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| 26 | 2021-01-25 | headache, throat pain, fatigue |
Sore throat; Headache; Fatigue; Muscle and Joint pain; Muscle and Joint pain; This is a spontaneous ...
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Sore throat; Headache; Fatigue; Muscle and Joint pain; Muscle and Joint pain; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302; expiry date: unknown) intramuscular, in the left arm, on 11Jan2021 at 09:15, at a single dose, for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), and seasonal allergies. Concomitant medications included minerals NOS, vitamins NOS (PRENATAL VITAMINS), calcium, fexofenadine hydrochloride (ALLEGRA), and esomeprazole magnesium (NEXIUM). The patient previously received ibuprofen and drospirenone and experienced allergies; and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284) intramuscular in the left arm, on 21Dec2020, for COVID-19 immunization. On 11Jan2021, at 22:30, the patient experienced headache, fatigue, muscle and joint pain, and sore throat. The patient received naproxen and Tylenol as treatment for the events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 26 | 2021-01-26 | fever, throat pain |
25th Jan 2021-low grade fever, went to work anyway 26th Jan 2021-100.1-feels crappy-no work 27th Jan...
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25th Jan 2021-low grade fever, went to work anyway 26th Jan 2021-100.1-feels crappy-no work 27th Jan 2021-fever. Sore throat Her husband has a 99.8 fever
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| 26 | 2021-01-26 | throat pain, sweating, headache, chills, fever, fatigue |
Fatigue/severe body aches Fever of 100-101 degrees Chills/sweating Headaches Intermittent sore throa...
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Fatigue/severe body aches Fever of 100-101 degrees Chills/sweating Headaches Intermittent sore throat Intermittent nausea Elevated HR Has lasted two days after vaccination and caused me to miss work
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| 26 | 2021-01-26 | chills, headache, fever | Headache, body ache, chills, feel feverish |
| 26 | 2021-01-26 | migraine, fatigue |
I had a very sore arm which is normal, however the day after I received the vaccine I was extremely ...
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I had a very sore arm which is normal, however the day after I received the vaccine I was extremely nauseous and I threw up 5x at 7:30 AM. I had a migraine the rest of the day and was extremely tired, sleeping a total of 19 hours.
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| 26 | 2021-01-26 | dizziness | Vertigo/dizziness; getting better at 1/27 11AM but still experiencing spells of dizziness |
| 26 | 2021-01-26 | chills, fatigue, headache |
fatigue; Chills; headache; body aches; This is a spontaneous report from a non-contactable Other HCP...
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fatigue; Chills; headache; body aches; This is a spontaneous report from a non-contactable Other HCP. A 26-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), intramuscular on the left arm on 12Jan2021 08:30 at single dose for COVID-19 immunization. The patient medical history included allergies. Concomitant medication included unspecified medication. The patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) on 22Dec2020, intramuscular on the left arm. The patient experienced fatigue, chills, headache and body aches on 13Jan2021 06:00. The patient was recovering from the events. No treatment was received in response to the events. No follow-up attempts are possible. Information on lot/batch cannot be obtained.
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| 26 | 2021-01-26 | fatigue, dizziness, weakness, fever |
syncope; Fever; Joint pain; Weakness; Dizziness; Tachycardia; Fatigue; This is a spontaneous report ...
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syncope; Fever; Joint pain; Weakness; Dizziness; Tachycardia; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EL3302 via an unspecified route of administration in left arm, on 12Jan2021 17:00 at single dose for covid-19 immunisation. Previously the patient received the first dose of BNT162B2 on 22Dec2020 at 17:00, lot number EJ1685, in left arm, for covid-19 immunisation. The vaccine was administered at Hospital Facility. No other vaccine was administered in four weeks. No COVID prior vaccination. COVID was not tested post vaccination. No known allergies. Medical history included asthma and postural orthostatic tachycardia syndrome, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 12Jan2021 the patient experienced syncope, fever, joint pain, weakness, dizziness, tachycardia, fatigue. The events required Physician Office visit. The patient was not treated for the events. The outcome of the events was resolving.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 26 | 2021-01-27 | weakness, chills, headache, malaise, fever |
chills; body aches; fever up to 103.8; headache; weakness; malaise; This is a spontaneous report fro...
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chills; body aches; fever up to 103.8; headache; weakness; malaise; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246) on her left arm, via an unspecified route of administration on 13Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included Asthma and GERD. Concomitant medication included baclofen, buspirone hydrochloride (BUSPAR), paracetamol (TYLENOL). The patient previously took protonix, reglan and ambien; experienced allergies with all. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Dec2020 (first dose). The patient experienced chills, body aches, fever up to 103.8, headache, weakness and malaise; all on 13Jan2021 23:00. No treatment has been received for the events. The outcome of the events was not recovered.
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| 26 | 2021-01-27 | body temperature increased, chills, fatigue, lethargy |
severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib...
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severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; Nausea; body aches; Cold and hot flashes with rigors; Cold and hot flashes with rigors; Cold and hot flashes with rigors; significantly warm to touch; Fatigue; lethargy; site of pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 04Jan2021 19:45 at a single dose for covid-19 immunization. Medical history included asthma and sulfa drug allergies. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included albuterol [salbutamol] (ALBUTEROL), montelukast sodium (SINGULAIR) and vitamins nos (MULTIVITAMIN). The patient has not had other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 06:30 AM at a single dose for covid-19 immunization which had no reaction other than slight tenderness at injection site. The patient received her vaccine in a hospital. The patient reported that within approximately 12 hours of second dose, she had severe pain in left arm/neck/rib. The pain was spasm-like and tight. She mentioned that the nausea was related to periods of pain. The patient had cold and hot flashes with rigors. The patient mentioned that she did not have access to thermometer, but significantly warm to touch. The patient added that she has fatigue /lethargy and body aches. It was reported that the systemic symptoms resolved within 24 hours while the site pain. Interventions done by the patient included acetaminophen, ibuprofen and ice pack to site of pain. The patient has been tested post vaccination, a nasal swab which was negative on 06Jan2021. The outcome of the events was recovered on Jan2021.
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| 26 | 2021-01-28 | headache, discomfort, chills |
Body aches, upset stomach, mild chills: lasted ~8hrs Headache: lasted ~12hrs Sore arm (injection si...
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Body aches, upset stomach, mild chills: lasted ~8hrs Headache: lasted ~12hrs Sore arm (injection site): ~42+hrs (still mild discomfort at this time)
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| 26 | 2021-01-28 | fever, fatigue, chills |
Chills; Fever; Hot flashes; Body aches; Fatigue; This is a spontaneous report from a contactable nur...
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Chills; Fever; Hot flashes; Body aches; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiration: 30Apr2021), via injection in left upper arm on 13Jan2021 at 15:00 at a single dose for vaccination. Medical history and concomitant medication reported as none. No family medical history. The patient received her first dose of COVID-19 vaccine via injection to left upper arm on 23Dec2020 at around 1:00pm-2:00pm (Lot: EK5730, Expiry: 31Mar2021, NDC: 59267-1000-2). The patient received her second dose of COVID-19 vaccine on 13Jan2021 in a public health department. She called to report the side effects she experienced since about 06:30 AM on 14Jan2021 which includes chills, fever, hot flashes, body aches, and having a lot of fatigue. She was sent home from work on 14Jan2021 related to the reported adverse events. Chills continued through most of the night from 14Jan2021 to 15Jan2021. On 14Jan2021, she had fever of 102 degrees Fahrenheit that was ongoing throughout most of days. The patient is now feeling fine, all events have improved. She used ice packs for the adverse events and had taken Tylenol 2 rounds of 500mg strength products for total of about 2000mg throughout 14Jan2021 to 15Jan2021. The patient confirmed that there were no concomitant products or other medical conditions to report and has no existing medical condition. She verified that she has had no testing/investigations/lab work/imaging/diagnostic work done relative to the report. No additional vaccines administered on same date of the vaccine. The patient did not require emergency room/physician's office visit. The patient has no prior vaccinations within 4 weeks. The patient did not have adverse event prior vaccinations. No relevant test done. The patient was recovering from the events. The events chills, fever, hot flashes, body aches, fatigue were assessed as related by primary source reporter.
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| 26 | 2021-01-28 | fever | Feeling cold in the afternoon 1/28/2021. 101 fever on 1/29/2021. |
| 26 | 2021-01-28 | sweating, headache, chills |
Headache; chills; sweating; nausea; tonsil stones; muscle aches; This is a spontaneous report from a...
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Headache; chills; sweating; nausea; tonsil stones; muscle aches; This is a spontaneous report from a contactable other healthcare professional (reported for herself). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular (left arm) on 12Jan2021 (12:15 PM) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) intramuscular (left arm) on 23Dec2020 (03:00 PM) for Covid-19 immunization. The patient's medical history included migraines and anemia; no known allergies. Concomitant medications included spironolactone, frovatriptan succinate, ethinylestradiol, norgestimate (TRI-SPRINTEC), and ferrous sulfate. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache, chills, sweating, nausea, tonsil stones, and muscle aches on 13Jan2021 (07:00 AM). There was no treatment received for the adverse event. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
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| 26 | 2021-01-28 | body temperature increased, fatigue, headache |
Severe headache, nausea, all-over muscle pain, joint stiffness, fatigue, temp went up but not enough...
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Severe headache, nausea, all-over muscle pain, joint stiffness, fatigue, temp went up but not enough for a fever. I took Bayer for the muscle pain and slept. Developed soreness of injection site approximately an hour after injection. Muscle stiffness and joint pain began that night. Other symptomst started Thursday morning and ended Friday morning.
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| 26 | 2021-01-28 | fatigue | Tachycardia first 10 minutes, soreness in arm for 3 days and fatigue following day. |
| 26 | 2021-01-28 | headache, fever | Woke up the following morning with a headache, fever, body aches, stomach ache |
| 26 | 2021-01-28 | fatigue | fatigue, body aches, back pain, pain at injection site |
| 26 | 2021-02-01 | shortness of breath, sweating, headache, chills |
Blisters around hips, thighs, and elbows.; Intermittent chest pain and tightness; Intermittent chest...
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Blisters around hips, thighs, and elbows.; Intermittent chest pain and tightness; Intermittent chest pain and tightness; shortness of breath; Swollen lymph nodes under bilateral arms that have not decreased; Chills; sweating; Headache; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= ELO140), via an unspecified route of administration at left arm on 14Jan2021 12:00 at single dose for covid-19 immunization. Medical history included known allergies: cephalosporins, coconut. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 05:00 AM, the patient experienced blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine and continuing into day 4 DOST vaccine, swollen lymph nodes under bilateral arms that had not decreased, chills and sweating, headache. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures post vaccination which included COVID nasal swab test and COVID PCR test, both were negative on 14Jan2021. The outcome of events was not recovered.; Sender's Comments: The reported blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 26 | 2021-02-01 | headache, chills |
Itchy neck, head, back and knees. Was released to go home and take Benadryl. Headache later that nig...
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Itchy neck, head, back and knees. Was released to go home and take Benadryl. Headache later that night into Sunday and Monday. Chills and muscle aches
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| 26 | 2021-02-02 | fever, weakness, chills, headache |
Sore arm after injection. I could bearly move it. Fever chills, weakness headache and body pains for...
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Sore arm after injection. I could bearly move it. Fever chills, weakness headache and body pains for 24 hours. I did not seek treatment but I will be letting my OBGYN know at the next appointment.
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| 26 | 2021-02-03 | headache, throat pain, fever, fatigue |
tired; head feels fuzzy; throat and neck pain; throat and neck pain; hurts to swallow; Low grade fev...
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tired; head feels fuzzy; throat and neck pain; throat and neck pain; hurts to swallow; Low grade fever/low grade temp of 99.4; Headache; body aches; This is a spontaneous report from a contactable Nurse (patient). A 26-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left deltoid on 20Jan2021 11:00 at 0.3 mL, single for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient received her first dose yesterday at 11:00am. She was talking to someone and all of a sudden she got throat to neck pain that was intense that lasted two minutes on 21Jan2021. It has been about 10-15minutes since and if she hold her neck straight she is fine, but if she looks up it hurts. She can breathe fine. It hurts to swallow all of a sudden on 21Jan2021. Asking if it is normal to experience this. She had a low grade fever/low grade temp of 99.4, body aches, and a headache that started today 21Jan2021. She received Tylenol as treatment. States she is a nurse and she is tired. Her head feels fuzzy, she has not taken her temperature recently and it still hurts to swallow. The events did not require a visit to emergency room or physician office. Relatedness of drug to events from reporter for throat and neck pain, hurts to swallow, low grade fever, headache, body aches was reported as related. Reporter seriousness for throat and neck pain and hurts to swallow was medically significant. Event outcome of throat and neck pain was recovered, of hurts to swallow was not recovered, of others was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: The reported events were likely causally related to the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. However, it is worth noting that the reporter/user of the vaccine was nurse, and her tiredness from job could have confounded with the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 26 | 2021-02-07 | head discomfort, fever | 35 weeks pregnant, fever of 102 chills, body aches and head pressure |
| 26 | 2021-02-07 | migraine |
mental confusion; inability to speak/tried to say things and it was a jumbled, meaningless string of...
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mental confusion; inability to speak/tried to say things and it was a jumbled, meaningless string of words; felt very cold; tingling around the mouth; aura like a bad migraine; bright spotty vision in the peripheral right field; bright spotty vision in the peripheral right field; thought she was having a stroke; EKG showed peaked T waves, common with dehydration and high potassium; EKG showed peaked T waves, common with dehydration and high potassium; EKG showed peaked T waves, common with dehydration and high potassium; likely a severe migraine; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231, expiration date was unknown), intramuscularly on the left arm on 30Dec2020 at 14:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic. Relevant medical history included COVID-19, which was diagnosed prior to vaccination and migraines (before). The patient had no allergies to medications, food, or other products. Concomitant medication included melatonin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 at 15:45 or 1 hour after the vaccine injection, the patient had an aura like a bad migraine and she had bright spotty vision in the peripheral right field for 15-20 minutes; the patient has had migraines before, but they're not common for her. Two hours after the vaccine, on 30Dec2020 at 16:45, the patient had mental confusion and an inability to speak; she tried to say things to her husband and it was a jumbled, meaningless string of words. She also felt very cold and she had tingling around the mouth. Her husband thought she was having a stroke and called 911 on 30Dec2020. All her vitals were stable, and within 10 minutes she could speak again. On 30Dec2020, the patient's electrocardiogram (EKG) showed peaked T waves, common with dehydration and high potassium. She was encouraged to go to the emergency room (ER). Instead of taking the ambulance, she drove herself several hours later. The patient wanted someone to tell her it wasn't a stroke. After a brief neurological exam on 30Dec2020, the doctor said it was likely a severe migraine and wrote the reason for her visit as a vaccine reaction. This took place in the late evening to early morning, and she missed one day of work. The events did result in an emergency room/department or urgent care visit. The reporter assessed the events as non-serious. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered from all the events on 31Dec2020.; Sender's Comments: Based on the close temporal relationship, the association between the event stroke with BNt162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 26 | 2021-02-17 | dizziness |
Spike in blood pressure - BP 178/120; Spike in pulse 120; Dizziness; slight chest pains; Arm tinglin...
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Spike in blood pressure - BP 178/120; Spike in pulse 120; Dizziness; slight chest pains; Arm tingling, turned into full arm pins/needles/Tingling spread through my left underarm and across left side of chest; This is a spontaneous report from a contactable pharmacist (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration into the left arm on 02Feb2021 14:15 at a single dose for covid-19 immunisation. Medical history included allergies to penicillin and mushrooms. Patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (APRI) for birth control. The patient previously took azithromycin and experienced drug allergy. On 02Feb2021 14:15, patient experienced spike in blood pressure (BP) 178/120 (unit unspecified), spike in pulse 120 (unit unspecified), dizziness, slight chest pains and arm tingling, turned into full arm pins/needles then tingling spread through her left underarm and across the left side of chest. The patient was treated with potassium tablets in the emergency room. Outcome of events was recovered on an unspecified date.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event blood pressure increased cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 26 | 2021-02-21 | fatigue, shortness of breath |
Patient had received vaccine on 2/20 and started to have extreme fatigue the night of the 20th. pati...
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Patient had received vaccine on 2/20 and started to have extreme fatigue the night of the 20th. patient states on Sunday 2/21 she was very short of breath and had some chest heaviness. Was taken to the ER where she was diagnosed with a vaccine reaction.
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| 26 | 2021-02-22 | shortness of breath |
Anaphylaxis - tachycardia, palpitations, shortness of breath, skin itching. Received epi pen and ER ...
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Anaphylaxis - tachycardia, palpitations, shortness of breath, skin itching. Received epi pen and ER transport. Now undergoing allergy testing.
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| 26 | 2021-02-22 | headache |
Developed red hives around neck and chest at 4 minutes post vaccination. Gave 25 mg tablet Benadry...
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Developed red hives around neck and chest at 4 minutes post vaccination. Gave 25 mg tablet Benadryl PO. At 7 minutes post vaccination had c/o feeling warm and having a headache. Vitals taken, vitals repeated 5 minutes later, still had c/o headache and feeling warm, chest hives redness was decreasing however, she was starting to itch on her back. At 11:15 an additional 25 mg tablet of Benadryl PO was given.
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| 26 | 2021-02-23 | fever | Severe muscle and joint pain, fever, and vomiting |
| 26 | 2021-02-25 | shortness of breath |
trouble breathing; This is a spontaneous report from a Pfizer sponsored program. A contactable consu...
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trouble breathing; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that she is a 26-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization at a hospital. Patient has a history of breathing problems (unspecified). On 06Feb2021, patient went into hospital due to trouble breathing. Treatment included antibiotics (unspecified) and prednisone 125 mg intravenous (IV) in the hospital and then took oral prednisone 40 mg for 4 days after being discharged on 10Feb2021. Patient further stated that she was in emergency for 4 days, and was given 125 mgs of prednisone, and that she was there in the emergency, but didn't want to stay, and was sent with prednisone and antibiotics, she was off the antibiotics not the prednisone after discharge. As of 11Feb2021, patient was off of prednisone. The patient had an unspecified blood work in the hospital and was reported to be everything was fine in Feb2021 had blood work. Outcome of the event was unknown. The patient does not feel like her breathing problems were related to the COVID-19 vaccine since she has a history of breathing problems that were aggravated in cold weather. The patient was to receive the second dose on 18Feb2021 and has inquired if she can take the shot given her problem. Information on batch/lot number has been requested.
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| 26 | 2021-02-28 | sweating, headache, fever, chills |
decreased appetite; Sweats; Chills; fever (101.3); headache; Body aches; This is a spontaneous repor...
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decreased appetite; Sweats; Chills; fever (101.3); headache; Body aches; This is a spontaneous report from a contactable Other-HCP (patient) and another other-HCP. This 26-year-old female received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL0142, intramuscular in left arm on 11Jan2021 at 07:00 as single dose (at the age of 26 years) for Covid-19 Immunization. Relevant medical history was reported as none and concomitant medication was not reported. The patient had historical vaccine on 21Dec2020 at the age of 26 years of BNT162B2 for Covid-19 immunization and experienced Onset of body aches 12 hours after vaccination and lasted for 24 hours. (Lot Number/Expiry Date: EH9899, Route: intramuscular). The patient experienced Body aches, headache, fever, chills, sweats on 11Jan2021 18:00 and recovered on 13Jan2021. Patient received Tylenol extra strength 100mg on 11Jan2021 for symptoms. Patient experienced decrease appetite on unspecified date with outcome of unknown. The other HCP consider the Pfizer product had a causal effect to the adverse event.
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| 26 | 2021-02-28 | fatigue, headache, fever, chills |
fever; chills; headache; overall fatigue; pain and tenderness at injection site as well as in the ar...
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fever; chills; headache; overall fatigue; pain and tenderness at injection site as well as in the armpit underneath the injection site; pain and tenderness at injection site as well as in the armpit underneath the injection site; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 26Jan2021 12:15 at a single dose for covid-19 immunization. Medical history included autoimmune thyroiditis (not yet clear if Hashimoto's or Graves), appendicectomy and pyelonephritis. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included methimazole, atenolol, valaciclovir hydrochloride (VALACYCLOVIR HCL), ethinylestradiol, norgestimate (NORGESTIMATE & ETHINYL ESTRADIOL) and magnesium. The patient did not receive other vaccine in four weeks. The patient previously took azithromycin but drug allergy. The patient received the first dose of of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 05Jan2021 02:15 PM at a single dose for covid-19 immunization but had pain and tenderness at the injection site. It was reported that the patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine in a hospital on 26Jan2021 12:15. On 27Jan2021 12:00 AM, the patient had fever, chills, headache, overall fatigue, pain and tenderness at injection site as well as in the armpit underneath the injection site. The events required treatment which included acetaminophen. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 26 | 2021-03-02 | migraine, fever, lethargy, shortness of breath |
Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; S...
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Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; Shortness of Breath; Severe joint pain; Migraine; Muscle pain; This is a spontaneous report from a contactable other healthcare professional (HCP reporting for self). A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 11:30 at a single dose in the right arm for COVID-19 immunization. Other medical history and known allergies were reported as none. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the report and vaccination. Concomitant medications included zinc, ascorbic acid (VIT C), ergocalciferol (VIT D) and an unspecified birth control medication. The first dose of BNT162B2 (brand: Pfizer as reported) was received on 06Jan2021 12:00 PM in the left arm for COVID-19 immunization. The patient had no other vaccine in the four weeks prior to second dose vaccination. On 27Jan2021 23:00, the patient experienced nose bleed, fever of 102, severe injection site swelling (grapefruit size), lethargy, tachycardia, shortness of breath, severe joint pain, migraine and muscle pain. The patient did not receive treatments for the reported adverse events. Patient had COVID test post vaccination specified as nasal swab on 27Jan2021 with test result as negative. The events were reported as recovered with lasting effects. Information on the Lot/Batch number has been requested.; Sender's Comments: Considering the close drug-event temporal association and the location, the reasonable possibility that the reported severe injection site swelling is related to BNT162B2 seems likely.
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| 26 | 2021-03-02 | fatigue, headache |
Soreness and swelling at injection site (right arm); Soreness and swelling at injection site (right ...
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Soreness and swelling at injection site (right arm); Soreness and swelling at injection site (right arm); Fatigue; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient). This 26-year-old non-pregnant female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via unspecified route of administration in the right arm on 27Jan2021 at 11:00 (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not have COVID-19 prior to vaccination, and did not receive any other vaccines in the 4 weeks prior to vaccination. Concomitant medications included paracetamol (TYLENOL) from an unknown date for an unknown indication; ibuprofen (ADVIL) from an unknown date for an unknown indication; and ethinylestradiol, etonogestrel (NUVARING) from an unknown date for an unknown indication. On 27Jan2021 at 21:00 the patient experienced soreness and swelling at injection site (right arm), fatigue, nausea, and headache, all lasting 24 hours after inoculation. No treatment was received for the events. The clinical outcomes of soreness and swelling at injection site (right arm), fatigue, nausea, headache, were recovered on 28Jan2021 at 21:00. It was also reported the patient did not test for COVID-19 post vaccination.
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| 26 | 2021-03-02 | dizziness |
vertigo; light headedness; nausea; This is a spontaneous report received from a contactable other he...
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vertigo; light headedness; nausea; This is a spontaneous report received from a contactable other health professional (patient herself). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on left arm on 19Jan2021 12:15 at single dose for COVID-19 immunisation at hospital. Medical history included depression and anxiety. The patient had no allergies to medications, food, or other products. Concomitant medication included trazodone at 100 mg and sertraline at 150 mg; both are received within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, two weeks after vaccine (on 01Feb2021 22:00) the patient had onset of vertigo, light headedness, and nausea. Patient still experiencing vertigo 12 hours later. Did not imbibe alcohol or substances. Did not do strenuous activity. The adverse events result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events were assessed as non-serious by the reporter. The outcome of the events was reported as recovering. Information on the lot/batch number has been requested.
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| 26 | 2021-03-03 | fatigue, shortness of breath, dizziness, chills |
High blood pressure of 150/100; Arm swelling; Arm swelling/The swelling has gone down, but it is sti...
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High blood pressure of 150/100; Arm swelling; Arm swelling/The swelling has gone down, but it is still swollen. It is still hurting.; Tenderness; Feeling faint/Felt dizzy; Some trouble breathing; disoriented; Fatigue; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN5318), via an unspecified route of administration at left arm on 28Jan2021 at 16:55 (reported as 4:55 PM) at SINGLE DOSE for COVID-19 immunisation. It was given at a vaccination clinic. The patient had no prior vaccination within 4 weeks and had no adverse events following prior vaccinations and that was why she thought she would be fine. The patient had no additional vaccines administered on same date of bnt162b2. Medical history included anxiety, peanut allergy, tree nut allergy, and has had anaphylactic reaction in the past. Family history included her dad has heart disease and her half sister has heart disease. There were no concomitant medications. Historical vaccine included flu vaccine on an unspecified date for immunization. The patient stated, "You kind of feel yucky after the flu vaccine, but she has never had this with a flu shot." The patient stated that she hasn't had a flu shot in years. The patient asked if arm swelling was a normal occurrence after vaccination and if side effects can last for 4 days. The patient reported that she received the first dose of the COVID vaccine on 28Jan and afterwards experienced, arm swelling, and tenderness that has last for 4 days. She also reported experiencing feeling faint, high blood pressure of 150/100 and some trouble breathing on an unspecified date and nausea. The patient further reported that she was calling because she got her first dose of Pfizer's vaccine and she was curious if this was normal and if she needs to go see her doctor and she wants to report the symptoms. After she got the injection she felt super faint and got really high blood pressure on an unspecified date. She was not sure if it was because she had anxiety, but she had trouble breathing on an unspecified date. She got nauseated afterwards. Her arm swelled up really big and the swelling has stayed there for four days. Her arm was still swollen on an unspecified date. She has allergies and has had anaphylactic reaction in the past. She was still nauseated and feels super tired. The patient asked how long do the symptoms last. The patient's weight was reported between 122 to 123 pounds. The patient clarified that the nausea started 15 minutes after she got the shot on 28Jan2021. The nausea has lasted through this. She got chills the next day (29Jan2021) after the shot. She has felt super fatigue. The swelling has gone down, but it was still swollen. It was still hurting. She has no idea if that was normal. She also felt dizzy and disoriented after getting the shot. She was not sure if it was because her blood pressure was so high. It was high for her because her blood pressure was normally low. She thinks her blood pressure 150/100 after she got the vaccine. The outcome of all the events was unknown.
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| 26 | 2021-03-03 | chills, fatigue, headache |
nausea; vomiting; chills; joint and muscle pain; joint and muscle pain; headache; fatigue; This is a...
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nausea; vomiting; chills; joint and muscle pain; joint and muscle pain; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 26-year-old, on an unspecified date, at SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on an unspecified date, single dose for COVID-19 immunization. On an unspecified date, following administration of second COVID-19 vaccine, the patient experienced nausea and vomiting, chills, joint and muscle pain, headache, and fatigue. Onset of symptoms occurred approximately 5 hours after administration of medication and became progressively worse over the next 20-24 hours following administration of dose. Symptoms began to resolve around 26 hours post administration of medication. Outcome of the events was recovering at the time of the report. No follow-up attempts are possible. Information about batch number cannot be obtained.
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| 26 | 2021-03-08 | fever, headache |
Received both doses of Pfizer covid vaccine (1st dose on 1/21/2021, 2nd dose on 2/11/21. Then prese...
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Received both doses of Pfizer covid vaccine (1st dose on 1/21/2021, 2nd dose on 2/11/21. Then presented to ER on 3/08 with fevers, severe HAs and Back pain. Clean CXR, normal u/a, negative covid test. Evaluated by ID who feels meningitis is most likely diagnosis. unclear if there would be a relationship to the COVID vaccine or not.
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| 26 | 2021-03-10 | dizziness, shortness of breath, sweating |
Pt. has a history of dizziness/nausea after vaccination. 15 minutes after this vaccination, she had ...
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Pt. has a history of dizziness/nausea after vaccination. 15 minutes after this vaccination, she had a short 'seizure-like' episode accompanied with slight shortness of breath. Pt. was also very dizzy and nauseous. Sweating came shortly after. EMS was called immediately when first symptoms began. She was responsive the entire time and reported gradually feeling better after about 5-10 minutes. EMS did a prompt check-up and revealed no unusual findings.
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| 26 | 2021-03-14 | chills, fever |
chills; body aches; presumed fever; This is an initial spontaneous report from a contactable consume...
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chills; body aches; presumed fever; This is an initial spontaneous report from a contactable consumer. A 26-year-old female patient received second dose of BNT162B2 (Solution for injection, Batch/Lot: unknown), via an unspecified route of administration on 13Jan2021 at single dose for an Covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine of BNT162B2 as first dose on 22Dec2020 for Covid-19 immunisation. The patient stated eleven hours after dose, person woke up with chills, body aches, and presumed fever (temp not taken at that time). Continued throughout the day. Next morning, temp taken by person and was 99. Still slightly chilled at the time. Estimating adverse event start date as not sure if it was on 13 or 14Jan. Only that adverse events started 11 hours after dose. The patient underwent lab tests and procedures which included body temperature: 99 on. The outcome of the events for chills and presumed fever was not recovered and for body aches was recovered on an unspecified date of 2021. Information about Lot/Batch has been requested.
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| 26 | 2021-03-18 | fatigue, shortness of breath | Loss of taste and smell, Parosmia, Fatigue, Pain breathing |
| 27 | 2020-12-31 | fatigue |
I woke up with significant right-sided facial and eye swelling currently still present although impr...
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I woke up with significant right-sided facial and eye swelling currently still present although improved in severity. Other symptoms included pain/heat at injection site, myalgias, fatigue.
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| 27 | 2020-12-31 | headache |
Pfizer-BioNTech COVID-19 Vaccine EUA Extremely sore arm Ipsilateral neck stifness/soreness for great...
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Pfizer-BioNTech COVID-19 Vaccine EUA Extremely sore arm Ipsilateral neck stifness/soreness for greater than 72 hours Headache for 72 hours
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| 27 | 2020-12-31 | fever, chills |
Started to have soreness in the left arm the day after with body aches the next day (12/30). Then de...
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Started to have soreness in the left arm the day after with body aches the next day (12/30). Then developed low grade fever up to 99.9F, chills, and body aches on 1/1/21.
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| 27 | 2020-12-31 | skin warm |
shoulder redness/itching/warmth starting 7 days after injection. Advised to use warm compress/Tylen...
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shoulder redness/itching/warmth starting 7 days after injection. Advised to use warm compress/Tylenol/Benadryl. Advised f/u in UC or ED for any new/worsening symptoms of any kind
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| 27 | 2021-01-01 | dizziness |
Patient began to feel light headed immediately after vaccine was given. She noted ringing ears and d...
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Patient began to feel light headed immediately after vaccine was given. She noted ringing ears and dizziness. She No epinephrine was given and she was able to walk out after ten minutes of sitting with head held forward.
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| 27 | 2021-01-02 | dizziness |
Pt reports she has had an increased heart rate in the 110-120s for the past three days after receivi...
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Pt reports she has had an increased heart rate in the 110-120s for the past three days after receiving the COVID19 vaccination. Pt reports increased dizziness today, nausea, and in the past hour some chest tightness. Pt also reported recent travel to and from out of town, about 14 hours travel time in the past week and half. Pt given fluids, ruled out for illness and PE. Pt improved with fluids.
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| 27 | 2021-01-03 | dizziness, discomfort |
After the shot I was very light headed , and was taken to the side. Ate some candy , and felt better...
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After the shot I was very light headed , and was taken to the side. Ate some candy , and felt better after. About 6 days later is when I woke up with really puffy eyes. Then next day I noticed swelling on the bottom of my mouth , on both sides. Also , my whole right side of my face is swollen with a lot of pressure in it.
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| 27 | 2021-01-03 | headache, headache, chills, chills |
Delayed Moderate. Myalgias several hours later, worsened myalgias in the Evening, Shivering, "burni...
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Delayed Moderate. Myalgias several hours later, worsened myalgias in the Evening, Shivering, "burning up" no fever, headache, back pain, palpitations, left axillary lymph node (peach pit size) bilateral inguinal pain next day. Symptoms improved
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| 27 | 2021-01-03 | fever, chills | Fever, Chills, body aches for 96 hours after receving vaccine |
| 27 | 2021-01-03 | fatigue, dizziness |
Pfizer-BioNTech COVID-19 Vaccine EUA - Patient witnessed another patient with syncope prior to her i...
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Pfizer-BioNTech COVID-19 Vaccine EUA - Patient witnessed another patient with syncope prior to her injection. She was already anxious about receiving vaccination and this increased her anxiety, though she proceeded with immunization. Patient was in 15 min observation window in a chair and began to feel light-headed like she may pass out. A SWAT was called. With RN assistance, patient was lowered to the floor, with no loss of consciousness. Patient was pale and reported anxiety, racing /pounding heart, and felt hot with facial flushing. Patient was transferred to ED and was noted to be tachycardic (120s), but dropped to 80s. She noted that this episode felt different than her prior syncopal episodes associated with anemia. Patient was observed for 5 hours and discharged to home. Patient returned to ED roughly 2.5 hours later complaining of continued dizziness and unsteady gate. Patient was pale and anxious. Patient reported had not eaten/drank enough during her shift and received vaccine immediately post a stressful shift. Additionally, patient witnessed another patient have syncopal episode prior to her receiving her vaccine which made her anxious. Patient was given IV fluids and had electrolytes replacement. Patient additionally received diazepam. Patient was discharged at 2358 on 12/23. Patient returned to ED on 12/24 at 0239 complaining of near syncope and lightheadedness. Patient had tachycardia and self-reported palpitations. Received IV fluids and observation on telemetry with no rhythm disturbance. Patient discharged 1428 on 12/24. On 12/29, patient returned to ED at 0326 for continued dizziness, fatigue and near syncope. Was admitted for cardiac evaluation. Noted to have unprovoked tachycardia and was discharged with a Halter Monitor to evaluate cardiac symptoms. patient was discharged 12/31 at 1619
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| 27 | 2021-01-03 | skin warm | dime size reddish bump, warm to touch |
| 27 | 2021-01-03 | sweating, dizziness |
lightheaded, dizzy, tunnel vision, sweaty, felt like passing out within minutes of receiving vaccine...
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lightheaded, dizzy, tunnel vision, sweaty, felt like passing out within minutes of receiving vaccine.
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| 27 | 2021-01-03 | headache, headache, skin warm, skin warm |
received covid vaccine 12/30 then had rash on r side of face little shooting headache muscle weakene...
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received covid vaccine 12/30 then had rash on r side of face little shooting headache muscle weakeness on 12/31 11:00 am notices pins needles on left side of face. Resolved then at 5 pm it came back again for a few hours then went away. Then 1/1/21 left forhead tingling above eyebrow. Today feels a little stiffness on the side of my face. Also reported left ear hot and painful 12/31 at 11:00
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| 27 | 2021-01-04 | weakness, sweating, dizziness |
12/18/20- reports suddenly got sweaty, hands felt cold, then got nauseous. Reports vomitted x 1. Rep...
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12/18/20- reports suddenly got sweaty, hands felt cold, then got nauseous. Reports vomitted x 1. Reports the rest of the day felt tachycardiac for a few hours (HR 120-140) and dizzy. Started getting muscle aches/joint aches. Denies any recent COVID exposure. Tested positive for COVID In 8/2020. Reports hips/knees are throbbing today; Heart rate WNL. /// Presenting today due to intermittent presyncope and palpitations. Also notes generalized weakness. Patient evaluate 2 L of fluid given her Mirena IUD D-dimer was sent which was negative patient with no pleuritic symptoms or dyspnea to suggest pulmonary embolism. Otherwise hemodynamically stable on exam ambulates with no difficulty no focal neurologic deficits. Patient did describe on her initial presentation that she noted some weakness of her bilateral legs. Given her possible viral reaction and description of weakness it is possible the patient is developing an early autoimmune reaction however she has no evidence of GuillainBarré or transverse myelitis on my exam. We will plan to discharge with neurology follow-up as outpatient.
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| 27 | 2021-01-04 | fever |
Experienced muscle aches and redness at site of injection, body aches overall, and fever. I was test...
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Experienced muscle aches and redness at site of injection, body aches overall, and fever. I was tested for covid-19, flu, and a urinalysis was performed. All tests gave negative results. Ibuprofen was recommended for symptom management.
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| 27 | 2021-01-04 | headache, chills, fever |
Fever, chills, body aches, headache and abdominal pain. Took second dose yesterday, I was feeling fi...
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Fever, chills, body aches, headache and abdominal pain. Took second dose yesterday, I was feeling fine and it all came back.
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| 27 | 2021-01-04 | malaise, chills, headache, fever |
Got second shot in the morning: Last night 11:00pm started having fever 101, chill, bad headache. T...
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Got second shot in the morning: Last night 11:00pm started having fever 101, chill, bad headache. Took Tylenol. Today has a little headache, no fever, chills are better. Don't feel well enough to go to work.
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| 27 | 2021-01-04 | fatigue, chills, headache |
I remainder of the day I rested. The next day I rested all day as well and was fatigued, had a mild...
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I remainder of the day I rested. The next day I rested all day as well and was fatigued, had a mild headache, muscle aches and felt the cold shivering feeling but had no fever.
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| 27 | 2021-01-04 | chills, dizziness, weakness, headache |
Saturday night headache took Tylenol, Sunday body aches chills headache dizzy nauseous weak, Monday ...
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Saturday night headache took Tylenol, Sunday body aches chills headache dizzy nauseous weak, Monday vomiting headache dizzy heart palpitations body aches, Tuesday continued headache body aches
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| 27 | 2021-01-05 | fever |
12/31 Fever and Boday Aches 1/1 Itchy rash, both arms Treatment Tylenol, Benadryl, Hydrocortisone cr...
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12/31 Fever and Boday Aches 1/1 Itchy rash, both arms Treatment Tylenol, Benadryl, Hydrocortisone creme Outcome as of 1/4, fever gone, rash continues.
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| 27 | 2021-01-05 | sweating |
Approx 3 min after vaccine administration hives and redness began to develop on chest and quickly as...
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Approx 3 min after vaccine administration hives and redness began to develop on chest and quickly ascend upwards to face. Had swollen/"thickening"/tightness feeling in neck. HR 115-120, sweaty and shaking slightly. 50mg PO Benadryl administered immediately. Taken to Emergency Department where IV SoluMedrol and Pepcid were given with improvement of symptoms. Vital signs and symptoms improved by discharge from Emergency Department.
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| 27 | 2021-01-05 | chills, dizziness |
Cervical lymphadenopathy; Chills; Nausea; Feeling lightheaded; This is a spontaneous report from a c...
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Cervical lymphadenopathy; Chills; Nausea; Feeling lightheaded; This is a spontaneous report from a contactable physician (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/4130421), via an unspecified route of administration on 29Dec2020 10:00 in left arm at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included linaclotide (LINZESS) and a combination birth control pill both received within 2 weeks of vaccination. On 29Dec2020 at 10:00 PM (22:00), the patient experienced chills, nausea, feeling lightheaded and cervical lymphadenopathy. The symptoms were severe enough that the patient needed to leave work in the middle of her shift (primarily due to the lightheadedness). The patient tried drinking juice, water, etc but it kept getting worse so after a few hours the patient decided she needed to leave work. The patient did not received treatment for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 27 | 2021-01-05 | migraine |
Diarrhea; throwing up; very bad migraines; This is a spontaneous report from a contactable consumer ...
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Diarrhea; throwing up; very bad migraines; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration on 27Dec2020 at single dose shot left arm once for COVID-19 immunization in hospital. The patient's medical history and concomitant medications reported as no. Patient stated that she got her Covid vaccine on Sunday (27Dec2020) and had experienced very bad migraines on 27Dec2020, diarrhea and throwing up as well on 29Dec2020. Stated that the diarrhea was not as common as the migraines. Stated that she had not thrown up but did last night (30Dec2020) at 2 AM. Investigation Assessment reported as no. No treatment was received for the events. The outcome of event migraines was unknown, outcome of the other events was recovering.
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| 27 | 2021-01-05 | chills, fever |
EE report symptoms of left arm pain, fever of 101 , chills, and mild body aches. Treatment include T...
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EE report symptoms of left arm pain, fever of 101 , chills, and mild body aches. Treatment include Tylenol with symptom improving.
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| 27 | 2021-01-05 | chills, fever, headache |
High fever between 102 and 106.1, chills, nausea and vomiting, headaches, and body aches. Treated wi...
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High fever between 102 and 106.1, chills, nausea and vomiting, headaches, and body aches. Treated with Tylenol and ibuprofen, fluids, and cool rags. Symptoms began 1/4/21 around 8pm with a fever of 102 that increased through the night to 104 after vomiting.
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| 27 | 2021-01-05 | headache |
I experienced swelling in my face and lips, my chest became covered in hives. I was nauseated and ...
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I experienced swelling in my face and lips, my chest became covered in hives. I was nauseated and felt like their was acid in my stomach (burning sensation). I had a headache. Was in the ED 12/31/20. Symptoms continue to happen at random.
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| 27 | 2021-01-05 | headache |
I experienced swelling in my face and lips. Hives on my chest and neck. I went to the ED 12/31. I fe...
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I experienced swelling in my face and lips. Hives on my chest and neck. I went to the ED 12/31. I felt nauseated and there was a burning in my stomach. I had a headache. I have been experiencing these symptoms at random since the vaccine.
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| 27 | 2021-01-05 | dizziness, weakness |
Sudden onset shakiness and became light headed with tunnel vision. Almost passed out. Episode lasted...
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Sudden onset shakiness and became light headed with tunnel vision. Almost passed out. Episode lasted about 5 minutes but generalized weakness lasted for about an hour.
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| 27 | 2021-01-05 | weakness |
Unspecified general vertigo, general weakness, and occasional nausea starting from morning after vac...
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Unspecified general vertigo, general weakness, and occasional nausea starting from morning after vaccination that has been steadily improving day by day. Have tried meclizine OTC to no effect. Vertigo is mild and not impairing. Able to keep balance fine.
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| 27 | 2021-01-05 | dizziness, weakness, discomfort | WEAKNESS, HEAVY FEELING , FEELING LIKE GOING TO PASS OUT, CHEST HEAVINESS |
| 27 | 2021-01-05 | fever, chills, headache, fatigue |
sore injection site the next day, next day at 10am began experiencing aches in my joints and achey m...
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sore injection site the next day, next day at 10am began experiencing aches in my joints and achey muscles all over, mild headache, fatigue. At around 1pm experienced chills and fever. Experienced 3 episodes of diarrhea that started about 5 hours after the vaccine.
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| 27 | 2021-01-06 | dizziness |
15 minutes after administration: began experiencing light headedness, nausea, and tightness in chest...
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15 minutes after administration: began experiencing light headedness, nausea, and tightness in chest 1 hour after administration: began experiencing tightness in throat, irregular heart beat, and hypertension, anxiety/feeling of impending doom
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| 27 | 2021-01-06 | chills |
After I got the vaccine I started exp chills and body ache on 12/22.I went to employee health to ge...
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After I got the vaccine I started exp chills and body ache on 12/22.I went to employee health to get tested. Since then I returned to work on 1/4 still can't smell/taste .I have to wait 90 days until I receive my 2nd dose Covid vaccine.
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| 27 | 2021-01-06 | fatigue, headache, chills, fever | Day 6 post shot: low grade fever, Body Aches, Chills, Tiredness, Headache and nausea |
| 27 | 2021-01-06 | dizziness | Dizziness, blurred vision, nausea. Taken to ED from vax site. Given IVF, Zofran inj. |
| 27 | 2021-01-06 | fatigue, headache | Fatigue, Headache, Body aches for 1 day, helped with 1 gm of tylenol |
| 27 | 2021-01-06 | chills, sweating, headache | Headache, Temperature, Body Aches, Chills, Sweaty |
| 27 | 2021-01-06 | headache, chills, fatigue | Myalgias, chills, fatigue, headache |
| 27 | 2021-01-06 | fever | Nausea/vomiting, fevers, painful supraclavicular lymphadenopathy, body aches |
| 27 | 2021-01-06 | headache |
Persistent throbbing headache started around midnight on 12/21/20. The headache did not subside with...
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Persistent throbbing headache started around midnight on 12/21/20. The headache did not subside with Tylenol, rest, nutrients, or hydration. The headache worsened with any head movements and made completing activities difficult. The headaches stopped by the morning of 12/23/20.
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| 27 | 2021-01-06 | headache | Pt experienced vertigo, spinning and headaches after vaccine administration |
| 27 | 2021-01-06 | chills |
Roughly 10 hours after receiving 2nd dose of the vaccine, woke with chills and severe body aches. To...
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Roughly 10 hours after receiving 2nd dose of the vaccine, woke with chills and severe body aches. Took 400 mg ibuprofen and put on additional layers and was eventually able to sleep for a couple more hours. Chills improved during mid-day, but body aches remained. Approaching 22-24 hours post vaccine, chills and body aches worsened. Took oral temperature in the evening which read 100.5 F. Took additional 400 mg ibuprofen and fluctuated between hot and cold for the rest of the evening. Awoke the next day(~36 hours post dose) and fever was gone but mild chills and body aches remained. Symptoms virtually gone by early afternoon (slightly before 48 hours after dose).
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| 27 | 2021-01-06 | headache |
Soreness from site of shot that radiated to most of my muscles and joints including shoulders, back,...
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Soreness from site of shot that radiated to most of my muscles and joints including shoulders, back, wrists, hips, and thighs. I also experienced nausea and a slight headache. I was unable to sleep because of my symptoms for at least 5 hours. I still am having some symptoms or aching as of 11:30am on 01/07/2021
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| 27 | 2021-01-06 | headache, fever, chills | chills, nausea, body aches, headache, fever |
| 27 | 2021-01-06 | headache, chills, sweating, fatigue | chills/sweats, head ache, body ache, joint pain, fatigue |
| 27 | 2021-01-07 | fatigue, dizziness, chills, body temperature increased |
12/22 vaccination. Within a few minutes, after sitting down, I started to get really dizzy, lighthea...
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12/22 vaccination. Within a few minutes, after sitting down, I started to get really dizzy, lightheaded. Intermittent chills. Symptoms lasted 20 minutes. 12/23 24 hour post vaccine, symptoms returned. myalgia. Temp was higher then normal baseline; 99.4. 12/24 still had dizziness. called employee health; mild / moderate reaction to vaccine. Tylenol. Dizziness resolved. 12/25 symptoms resolved. Following Monday, afternoon, felt extremely fatigued. Touched base with COVID committee; UPMC/advised to get titers checked.
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| 27 | 2021-01-07 | chills, dizziness, fatigue |
Approximately 24 hours after receiving dose 1 of the Pfizer vaccine, I began having chills and vomit...
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Approximately 24 hours after receiving dose 1 of the Pfizer vaccine, I began having chills and vomited. My fatigue became more severe as well. Later that evening my fatigue persisted and I noticed a rapid heart rate via my Watch. My resting heart rate which usually is about 80 BPM was at 100 while laying down and not engaged in any physical activity. When I stood I was dizzy and had poor balance. While my entire arm no longer hurt, the injection site showed a bump as well. When I awoke the next day my heart rate appeared normal again, and I wasn't especially fatigued compared to before I got the vaccine. I did experience another minor gastro-intestinal episode later that afternoon, but otherwise my symptoms appeared to have passed aside from the fatigue. By the end of my work day I was very tired again, although it is uncertain if this is due to the vaccine or from my continued recovery from Covid and adjusting to the physical demands of going back to my job in-person. Because I received my vaccine on the same day as my first day back to work, I have no experience working post-covid before having the vaccine to compare my current state of fatigue to. On the evening of 01/07 I noted that fatigue was slightly less pronounced. I do not currently have a primary care doctor but will be calling to try to gain an appointment so that my second dose can be monitored.
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| 27 | 2021-01-07 | chills, fatigue | Body Aches, Chills, Vomiting, Extreme tiredness, Swelling at the injection site. |
| 27 | 2021-01-07 | shortness of breath |
Day off: Arm sore One day after: Lump, arm sore, body aches, trouble breathing 2nd day to current: i...
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Day off: Arm sore One day after: Lump, arm sore, body aches, trouble breathing 2nd day to current: injection site lump is sore and itches, trouble breathing, body aches
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| 27 | 2021-01-07 | headache, dizziness |
Dizziness elevated heart rate HA . Dizziness and elevated HR resolved later per the patient nad did ...
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Dizziness elevated heart rate HA . Dizziness and elevated HR resolved later per the patient nad did not feel like her MS
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| 27 | 2021-01-07 | fatigue, chills |
Fatigue; achy; chills; This is a spontaneous report from a contactable other hcp (patient). A 27-yea...
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Fatigue; achy; chills; This is a spontaneous report from a contactable other hcp (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 04Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included known allergies to shellfish. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. The patient experienced fatigue, achy, chills, all on 05Jan2021 01:15. No treatment received for the adverse events. This a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.
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| 27 | 2021-01-07 | fever, headache |
Fever started on 1/7 at around 7:00am, highest was 100.2, Took tylenol Nausea, headache, body aches ...
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Fever started on 1/7 at around 7:00am, highest was 100.2, Took tylenol Nausea, headache, body aches as well
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| 27 | 2021-01-07 | dizziness, chills, fever |
Fever, chills, severe dizziness. Unable to even sit at the side of the bed without baseline out. (I ...
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Fever, chills, severe dizziness. Unable to even sit at the side of the bed without baseline out. (I do have pots but have been fully function without any currently symptoms of that)
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| 27 | 2021-01-07 | headache, shortness of breath |
Got 1st shot at 1430 1/4/21. Was sent back to my unit (OR). At 1455 got full body flush followed by ...
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Got 1st shot at 1430 1/4/21. Was sent back to my unit (OR). At 1455 got full body flush followed by tingling lips, tight throat, trouble swallowing and SOB. No obvious signs of swelling of the lips. Used inhaler for SOB which helped marginally. After 1.5 hrs tingling in lips and flushed skin went away. Throat tightness and SOB still remained but weren't progressing so went home after my shift. Later that night around 2100 took 1 25mg Benadryl. Tightness in throat and SOB improved. The next morning 1/5/21, I reported to work for my shift. Tightness and SOB was manageable at this point. At 0800 the tightness in my throat, trouble swallowing and SOB got significantly worse. I was scrubbed into a surgery and had to call for a replacement so I could take Benadryl. I took 1 25mg tablet and 2 puffs of my inhaler and went back to my case. After the Benadryl and inhaler, the tightness in my throat and SOB became slightly more manageable. At 1240 the symptoms came back and I took another Benadryl and 2 puffs of my inhaler with slight relief of symptoms. Stayed the rest of my shift continuing my inhaler as needed and a Benadryl every 4 hrs. At 1600 I developed a headache at the front of my head above my eyes like a weight was sitting there. The next day when I woke up 1/6/21, the tightness in my throat, SOB and headache were worse so I had to call into work. The headache that morning had progressed to 7 out of 10 pain and the pain then included my neck where it attaches to the skull. At 0830 I called employee health and they advised my to go to an urgent care. I was checked over by a PA and was prescribed prednisone 40 mg for 5 days along with Benadryl every 4 hrs and inhaler as needed. I was also nasal swabbed for Covid. After taking the steroid, the headache and neck pain, tightness in throat went away. The SOB also improved. Currently taking the steroid, Benadryl (every 4 hrs) and inhaler 2 puffs as needed. Symptoms are mostly controlled. 1/7/21 tried to cut back the Benadryl to every 6 hrs. Noticed a huge difference in my breathing and had an increase in SOB so went back to every 4 hrs. 1/8/21 still taking steroid and Benadryl every 4 hrs and inhaler. SOB is worse today even with taking Benadryl. Have an appointment with my PCP to talk about getting the 2nd shot.
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| 27 | 2021-01-07 | headache | Head Ache, body aches, up all night |
| 27 | 2021-01-07 | headache | Headache, body aches, up all night. |
| 27 | 2021-01-07 | fever |
I received high temperature of a 100.1; Muscle aches; muscle pain; Body aches; nausea; I was develop...
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I received high temperature of a 100.1; Muscle aches; muscle pain; Body aches; nausea; I was developing soreness at the injection site of the arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration, on 31Dec2020 at 12:20, at a single dose, as preventive measure for COVID. The patient has no relevant medical history. There were no concomitant medications. The patient received the vaccine on 31Dec2020 about 12:20. On the same day, midafternoon, patient developed soreness at the injection site of the arm. The following day (01Jan2021), in the morning, she had a high temperature of a 100.1 along with some muscle aches/ muscle pain, body aches, and nausea. Outcome of the events was unknown.
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| 27 | 2021-01-07 | headache, fever, fatigue |
Myalgia & Fever Narrative: Pfizer covid 19 mRNA given 1/4/2021 left arm vaccination site (IM) at 1:1...
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Myalgia & Fever Narrative: Pfizer covid 19 mRNA given 1/4/2021 left arm vaccination site (IM) at 1:17 pm complained of muscle soreness Left arm 09:00 pm 1/4/2021. The next day - morning felt tired, muscle soreness, Headache esp bifrontal and retrobulbar. T 99.7 taken this morning and took Ibuprofen 600mg one tablet this morning. She still reported for work today but complained about these symptoms to Supervisor who consulted EOH providers Denied cough nor colds nor any upper respiratory symptoms A/P: Vaccine related side effects within 24 hours after vaccination Reported to facility admin Can return to work if she feels better tomorrow but without taking analgesics (ibuprofen) nor antipyretics (Tylenol) Informed Supervisor
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| 27 | 2021-01-07 | fever, chills, fatigue |
Severe body aches and chills. High grade temperature. Fatigue, extremely tired, joint pain. Symptoms...
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Severe body aches and chills. High grade temperature. Fatigue, extremely tired, joint pain. Symptoms particularly reduced with ibuprofen 600 mg
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| 27 | 2021-01-07 | fatigue, chills, headache, malaise |
Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and f...
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Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 27-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), via intramuscular route of administration in the right arm on 30Dec2020 at 12:30 PM (at the age of 27 years-old) as a single dose for COVID-19 vaccination. There was no relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced tiredness, headache, chills, nausea, and feeling unwell. The report was reported as non-serious. The patient was not treated for tiredness, headache, chills, nausea, and feeling unwell. The clinical outcome of tiredness, headache, chills, nausea, and feeling unwell was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are Possible; Information about batch number cannot be obtained. No further information is expected
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| 27 | 2021-01-07 | fever, chills | fever, chills, myalgias - took 4 ibuprofens - lasted less than 24 hr |
| 27 | 2021-01-07 | fatigue |
injection site was swollen and hot and doubled in size also reports fatigue and slight discoloration...
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injection site was swollen and hot and doubled in size also reports fatigue and slight discoloration.
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| 27 | 2021-01-07 | chills, malaise, fever, weakness |
lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, pai...
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lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; fever that reach 101.5F; injection site pain; myalgia in the entire left arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 30Dec2020 18:00 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). Patient was diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not pregnant at the time for vaccination. Concomitant medication included metformin, ergocalciferol (VIT D), and tretinoin cream. Right after injection, the patient had injection site pain and myalgia in the entire left arm on 30Dec2020. The second day, 31Dec2020, about 19 hours after receiving the vaccine, patient started feeling unwell. The injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches on 30Dec2020. Patient developed a fever that reach 101.5F on 30Dec2020. She also experienced chills, tachycardia, and weakness about 24hours after injection on 31Dec2020. Patient experienced lymphadenopathy during the 3rd (01Jan2021) and 4th day (02Jan2021). Patient recovered with lasting effects (recovered with sequel). TYLENOL was received as treatment for the events except for lymphadenopathy. The reporter considered the events non-serious. Information on the Lot/Batch Number has been requested.
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| 27 | 2021-01-07 | nasal congestion, runny nose | swollen left eye, hives on arms and legs, stuffy/runny nose |
| 27 | 2021-01-08 | fever, chills, malaise |
Fever and chills began about 1 hours after vaccine, about 18 hours after vaccine I was getting up t...
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Fever and chills began about 1 hours after vaccine, about 18 hours after vaccine I was getting up to take more Tylenol and did not feel well, I had a syncope episode in the bathroom (no issues as I sat on the floor before hand). I was unconscious for about 1-2 minutes. My blood pressure several minutes later was low (about 90/50 but I took it myself so may not be exactly accurate)
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| 27 | 2021-01-08 | headache, fever |
Headache, nausea, diarrhea, hot flashes, mild fever, loss of concentration/focus, fatigue, muscle ac...
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Headache, nausea, diarrhea, hot flashes, mild fever, loss of concentration/focus, fatigue, muscle aches. 12/23-1/9 (present) 2 virtual dr visits, recommended Tylenol and rest
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| 27 | 2021-01-08 | nasopharyngitis, chills |
Mild body aches with moderate to severe body chills from 9pm until 5am the evening of the shot. Pati...
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Mild body aches with moderate to severe body chills from 9pm until 5am the evening of the shot. Patient was ?freezing? despite multiple thick layers of clothing and bed linens. Unclear if there was a fever involved - temperature was never taken at home during the event.
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| 27 | 2021-01-08 | malaise, headache, fatigue, chills | Moderate Headache and fatigue throughout day. Chills, generalized feeling of being unwell. |
| 27 | 2021-01-08 | shortness of breath, chills, dizziness, headache, fever |
Nausea, vomiting, diarrhea, fever, chills, dizziness, headache, muscle and joint aches, pain at the ...
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Nausea, vomiting, diarrhea, fever, chills, dizziness, headache, muscle and joint aches, pain at the injection site, dry mouth, shortness of breath. Took ibuprofen and Tylenol.
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| 27 | 2021-01-08 | dizziness, fever | NauseaVomiting Aggravation of POTS, dizziness, fever, nausea, muscle aches and pain Narrative: |
| 27 | 2021-01-08 | sweating, chills, fever |
Symptoms that began at 10pm the night I reviewed the vaccine included chills, fever, body aches. Thi...
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Symptoms that began at 10pm the night I reviewed the vaccine included chills, fever, body aches. This lasted till about 2am. Finally fell asleep and woke up at 8am very sore but much better. Around 3:30pm I started again with the same severe chills, fever, body aches and now nausea. Woke up in the middle of the night drenched in sweat. The following morning I woke up around 8am again with horrible mid/lower bilateral back pain. This lasted till about 1pm. It?s not 9pm and all symptoms have subsided. I feel hopeful, thanks for all you do!
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| 27 | 2021-01-08 | headache, sweating, weakness, somnolence, chills |
chills, muscle pain, join aches, elevated heart rate, weakness, headache @ 12 hours after injection ...
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chills, muscle pain, join aches, elevated heart rate, weakness, headache @ 12 hours after injection took 650mg tylenol, able to fall asleep awoke again with sweats (did not take temperature) able to fall asleep, slept a total of 18 hours still with headache, weakness, fatigue on wakening, took 325 mg tylenol and 200 mg advil symptoms resolved approximately 25 hours after injection
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| 27 | 2021-01-08 | fever, chills |
side effects lasted 24 hours. 12 hours after second dose, chills occurred. this was followed by feve...
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side effects lasted 24 hours. 12 hours after second dose, chills occurred. this was followed by fever and muscle aches. Highest fever was 101.7 F. side effects were bad enough to affect ability to do ADLs and to be able to go to work. Swollen lymph node in left clavicle since first dose got bigger and firmer. since symptoms have resolved swollen lymph node still there.
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| 27 | 2021-01-09 | fatigue |
24 hours after the 2nd vaccine on 1/7/21, I began experiencing joint pain in bilateral hands, finger...
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24 hours after the 2nd vaccine on 1/7/21, I began experiencing joint pain in bilateral hands, fingers, thumbs. Worsened over the next few days. Created difficulties with grip. Took ibuprofen, and applied heat/ice. General fatigue as well. Still recovering as of today 1/10/21.
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| 27 | 2021-01-09 | headache, night sweats, chills | Chills, headache, night sweats 2 days post shot and enlarged lymph node 4 days post vaccine. |
| 27 | 2021-01-09 | chills |
Chills, moderate body aches that made it difficult to work, joint pain. Improved with ibuprofen/napr...
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Chills, moderate body aches that made it difficult to work, joint pain. Improved with ibuprofen/naproxen
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| 27 | 2021-01-09 | chills, headache, fatigue | Diffuse myalgia and Arthralgia, fatigue, headache, chills |
| 27 | 2021-01-10 | headache |
14 minutes post injection, patient laid head on table and started shaking. Complained of severe head...
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14 minutes post injection, patient laid head on table and started shaking. Complained of severe headache, h ands, arms and legs numb. No resp problems. 7:50am given 12.5mg of Benadryl IM. 0800 shaking slowing down, but headache, tinglig in arms, legs still numb. 8:04another 12.5 mg of Benadryl IM given. 8:15 shaking stopped but headache continues. Legs remain "heavy" but arms normal. Patient complains of copper taste in mouth. 8:20 legs mostly back to normal. 8:30 able to walk with no symptoms at this time except for headache. Husband arrives to take patient home.
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| 27 | 2021-01-10 | chills, fatigue, fever |
24 hours of low grade fever ranging 99.6 -100.8, chills, body aches, fatigue. Symptoms lasted about ...
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24 hours of low grade fever ranging 99.6 -100.8, chills, body aches, fatigue. Symptoms lasted about 24 hours. Treated with Tylenol and ibuprofen. Fine 48 hours after vaccine.
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| 27 | 2021-01-10 | headache, fatigue |
Experienced fatigue and headaches beginning approximately 24 hours after vaccine injection. The fati...
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Experienced fatigue and headaches beginning approximately 24 hours after vaccine injection. The fatigue and headaches were most severe on the between 24-33 hours after injection then gradually subsided until adverse events were eliminated on Day 3, approximately 57 hours post injection. No treatment was taken to lessen side effects, simply rest.
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| 27 | 2021-01-10 | fatigue | Fatigue, body aches, diarrhea |
| 27 | 2021-01-10 | chills, headache, fever, weakness, fatigue, cough |
Fine for ~6-9 hours post injection. But then immediate fever (103F), body ache, extreme joint pain a...
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Fine for ~6-9 hours post injection. But then immediate fever (103F), body ache, extreme joint pain and a feeling of something eating away in my bones, chills, bruised/swollen/pain in left arm (injection spot), fever, fatigue, headache, light cough for 5 straight days. Not able to do normal activities. Took Tylenol and ice pack to alleviate fever. The day after injection, body fell so weak that my body acquired another viral infection (very unusual). No shortness of breath. Eating/drinking/appetite fine. No loss of taste/smell. I am exactly 1 week from the injection. No fever, just light headache. Able to resume normal activities but gets fatigued fairly quickly (after 3 hours). I am very active and work out 2 hours every day, but may not be able to do strenuous activity/exercise for some time... I was symptomatic covid last year in April 2019. This was very similar experience but an extremely debilitating, more intense version of the covid that I had. ***I am unsure if I should proceed with the second dose due to a very severe reaction to the first dose***
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| 27 | 2021-01-10 | chills, weakness |
I woke up in the middle of the night with chills, body aches, nausea, and over all weakness. I ended...
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I woke up in the middle of the night with chills, body aches, nausea, and over all weakness. I ended up throwing up. I only got 4 hours of sleep.
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| 27 | 2021-01-10 | chills, migraine | Migraine, body aches, chills, nausea beginning at 0300 the next day after receiving vaccine |
| 27 | 2021-01-10 | fatigue | Nausea, fatigue, left arm pain that sometimes shoots up my shoulder |
| 27 | 2021-01-10 | throat swelling |
Tachycardia and palpitations within 5 minutes of administration. Lasted for about 5 minutes then re...
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Tachycardia and palpitations within 5 minutes of administration. Lasted for about 5 minutes then resolved. Approximately 20 mins after administration of vaccine minor swelling of the throat and limited rash on the throat present. 50 mg oral Benadryl taken an hour after vaccination.
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| 27 | 2021-01-10 | weakness, shortness of breath |
Vaccine: 12/30/2020 0900 AM Symptoms started: 12/30/2020 0925 AM Symptoms: tachycardia 150s, weaknes...
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Vaccine: 12/30/2020 0900 AM Symptoms started: 12/30/2020 0925 AM Symptoms: tachycardia 150s, weakness, feeling extremely hot, lip and facial numbness, tightness on throat, difficulty swallowing, shortness of breath Duration: 1 hour Frequency post vaccination: QDAY but less severe ED Visit: 12/31/2020 prescribed Zyrtec and Pepcid Symptoms still occurring going on week two post vaccination
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| 27 | 2021-01-10 | fever, headache, chills | fever, chills, muscle ache, headache. called in sick to work. |
| 27 | 2021-01-10 | chills, headache, malaise |
she left a message that she had a second vaccine on Jan. 7 and on 1/8 was very sick with chills, hea...
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she left a message that she had a second vaccine on Jan. 7 and on 1/8 was very sick with chills, headache, shaky, and vomiting. She reports 1/9 that it is now gone (lasted about 24 hours).
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| 27 | 2021-01-10 | malaise, malaise | swelling redness at injection site, itching, muscle pain, not feeling well-all resolved |
| 27 | 2021-01-11 | dizziness |
At 2am that next morning January 8th (almost 12 hours post vaccine) I woke up out of my sleep deliri...
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At 2am that next morning January 8th (almost 12 hours post vaccine) I woke up out of my sleep delirious, light headed, heart was racing, diarrhea, and felt like I was falling in and out of almost passing out, hot flashes, couldn't think straight. It wasa very scary experience for me. This lasted about 15 or 20 minutes I'm guessing (hard to say for sure because I was too worked up to watch the clock) but I ended up making myself fall back asleep. The next day January 8th I had diarrhea multiple times in theafternoon and felt strange, somewhat lightheaded and some what felt like anxiety.
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| 27 | 2021-01-11 | fever | Body aches, Fever 102 |
| 27 | 2021-01-11 | headache, fever | Body aches, headache, low grade fever |
| 27 | 2021-01-11 | chills, headache | Chills, Headache, Nausea |
| 27 | 2021-01-11 | throat swelling | Dry and swollen mouth and back of throat about 25 min after shot |
| 27 | 2021-01-11 | chills, headache, fever |
Myalgias, arthalgias, and headache starting at 12 hours after vaccine. These lasted 24 hours. Fever,...
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Myalgias, arthalgias, and headache starting at 12 hours after vaccine. These lasted 24 hours. Fever, chills, and nausea starting at 22 hours after vaccine and lasted for 14 hours. L axilla lymphadenopathy starting 38 hours after vaccine. Treatment was tylenol and ibuprofen prn.
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| 27 | 2021-01-11 | throat irritation |
Patient complained of itching dermatitis throughout torso and face with visible hives. Patient compl...
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Patient complained of itching dermatitis throughout torso and face with visible hives. Patient complained of throat "feeling funny". Patient immediately transported by wheelchair 300 ft to ED.
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| 27 | 2021-01-11 | headache, fatigue, fever |
Pfizer-BioNTech COVID-19 Vaccine EUA: 1. Injection site tenderness x 2-3 days, no treatment 2. Fatig...
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Pfizer-BioNTech COVID-19 Vaccine EUA: 1. Injection site tenderness x 2-3 days, no treatment 2. Fatigue, severe headache, muscle pain, fever x 8-10 hours (started about 10 hours after getting the vaccine), Tylenol
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| 27 | 2021-01-11 | headache, chills, cough, fatigue, night sweats, malaise |
Poor sleep, dry cough and wheeze, flushing of cheeks, hot flashes, night sweats, chills, muscle pain...
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Poor sleep, dry cough and wheeze, flushing of cheeks, hot flashes, night sweats, chills, muscle pain like cramps and pins and needles if skin rubbed, joint pain, sharp brief headache that comes and goes in random spots of head, fatigue, malaise, mental fog
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| 27 | 2021-01-11 | headache |
The day after vaccine administration, pt was still experiencing vertigo, spinning and headache.; The...
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The day after vaccine administration, pt was still experiencing vertigo, spinning and headache.; The day after vaccine administration, pt was still experiencing vertigo, spinning and headache.; This is a spontaneous report from a non-contactable other healthcare professional (hcp). A 27-year-old female patient receive first dose of bnt162b2 (Pfizer BioNTech COVID vaccine, lot number: EL0140), intramuscularly on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. There is unknown if any other vaccine received in four weeks. The patient experienced the day after vaccine administration, patient was still experiencing vertigo, spinning and headache, all on 31Dec2020 the day after vaccine administration. The outcome of events was unknown. This is a non-serious report. It's unknown if patient was diagnosed with COVID-19 or tested for COVID-19 since the vaccination. The adverse did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
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| 27 | 2021-01-11 | chills, fever, headache |
body aches; headache; fever; body chills; wasn't able to sleep; pain throughout her arm/injection si...
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body aches; headache; fever; body chills; wasn't able to sleep; pain throughout her arm/injection site was extremely sore; This is a spontaneous report from a contactable healthcare professional. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ek9231/expiration date unknown), dose number 1, via an unspecified route of administration on 03Jan2021 14:15 at a single dose on the left arm for COVID-19 immunization. Medical history included migraines. Concomitant medications were not reported. The patient was fine the day she got the vaccine, but when it came to the night of 03Jan2021, she wasn't able to sleep due to the pain throughout her arm. On 04Jan2021 04:00, she woke up with a headache that was intense, fever, and body chills. The injection site was extremely sore to the point where she took some Tylenol and slept it off. On 05Jan2021, she felt a lot better, but still with mild body aches. The patient was not diagnosed with COVID-19 prior to vaccination. She was not tested for COVID-19 since the vaccination. The vaccine was received in a hospital. No other vaccines were given in four weeks. The outcome of the events was not recovered for body aches, and recovering for the other events.
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| 27 | 2021-01-11 | chills, fever |
developed hives on arm along with fever, chills and muscle aches. Self treated and symptoms resolve...
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developed hives on arm along with fever, chills and muscle aches. Self treated and symptoms resolved
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| 27 | 2021-01-11 | dizziness |
immediate after this vaccination for COVID-19 prevention, pt. developed lightheaded and dizziness sh...
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immediate after this vaccination for COVID-19 prevention, pt. developed lightheaded and dizziness she says. on questioning if BP was checked, she said BP was not checked. Denies ever getting lightheaded or dizziness with other types of vaccinations or immunizations so probable not vasovagal. Headaches she also reported arm aching at this vaccination site. initially said in 1/2 hour later she says 2 hours. She looked at the vaccination site on her arm for first time 8 hours after this vaccination. Found redness and blisters first time treated with diphenhydramine 5 mg. barely move arm next day. swelling arm lasted 2 days. photos of arm vaccination site she sent were reviewed. had video visit with Family Medicine Physician and later with video visit with Allergy Physician
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| 27 | 2021-01-11 | fever, throat pain, chills, headache |
patient states that she received vaccine on 11/11/21 at 10 am and symptoms started on n11/11/21 at 1...
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patient states that she received vaccine on 11/11/21 at 10 am and symptoms started on n11/11/21 at 11 pm and included: fever of 100.4 degrees Fahrenheit-relieved with tylenol, headache, body/muscle aches, chills, sore throat
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| 27 | 2021-01-12 | chills, headache, fever |
1/11 10:30pm-severe headache and jaw ache/stiff jaw 1/12 AM-headache and jaw ache continues, nausea ...
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1/11 10:30pm-severe headache and jaw ache/stiff jaw 1/12 AM-headache and jaw ache continues, nausea 1/12 afternoon-headache and jaw ache continues, nausea, low grade fever (99.9) and chills 1/12 night-headache and jaw ache 1/13 AM and afternoon-headache and jaw ache
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| 27 | 2021-01-12 | throat irritation |
About an hour after receiving the vaccine my throat became itchy and my soft palate had minor swelli...
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About an hour after receiving the vaccine my throat became itchy and my soft palate had minor swelling with bumps; About an hour after receiving the vaccine my throat became itchy and my soft palate had minor swelling with bumps; About an hour after receiving the vaccine my throat became itchy and my soft palate had minor swelling with bumps; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on the right arm 21Dec2020 08:00 at SINGLE DOSE for COVID-19 immunization at the hospital. It was reported that the patient had allergies with algae in lakes and had reaction (throat became itchy and soft palate had minor swelling with bumps). Concomitant medication included melatonin (MELATONIN). Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. On 21Dec2020 09:00 (about an hour after receiving the vaccine), the patient throat became itchy and her soft palate had minor swelling with bumps. The patient mentioned that algae in lakes gives me a similar reaction. The patient did not receive any treatment for the events. The patient recovered from the events on an unknown date.
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| 27 | 2021-01-12 | headache, fever | Fever of 100.2, body aches, headache |
| 27 | 2021-01-12 | chills, headache, fever | Fever, chills, body aches, headache, nausea |
| 27 | 2021-01-12 | chills, fever, headache |
Fever, chills, headache, body aches 12hrs after vaccine administration. Diarrhea 18hrs after admini...
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Fever, chills, headache, body aches 12hrs after vaccine administration. Diarrhea 18hrs after administration. Symptoms lasted 24hrs.
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| 27 | 2021-01-12 | headache, chills, fever, dizziness |
Fever; body aches; joint pain; headache; diarrhea; dizzy spells; uncontrollable shakes; chills; This...
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Fever; body aches; joint pain; headache; diarrhea; dizzy spells; uncontrollable shakes; chills; This is a spontaneous report from a Non-contactable Other Health Professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06Jan2021 13:45 at single dose for COVID-19 immunization. Medical history reported as none. Known allergies: NO (Allergies to medications, food, or other products: No). The patient's concomitant medications were not reported. List of any other medications the patient received within 2 weeks of vaccination: No. The patient experienced Fever, body aches, joint pain, headache, diarrhea, dizzy spells, uncontrollable shakes, chills, all on 06Jan2021 21:00 with outcome of recovering. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. No treatment received for the adverse event. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. Covid test post vaccination: Nasal Swab on 07Dec2021 with result negative. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
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| 27 | 2021-01-12 | fever, headache, chills | HEADACHE, FEVER, BODY ACHES, CHILLS. |
| 27 | 2021-01-12 | fatigue, headache | Headache, fatigue, swollen lymph node on the right side of neck |
| 27 | 2021-01-12 | fatigue, dizziness, fever |
Immediately after I got it I started feeling flush and hot in my face, I got dizzy and lightheaded, ...
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Immediately after I got it I started feeling flush and hot in my face, I got dizzy and lightheaded, my HR went to 180, my legs felt weak, I was having chest palpitations and chest pain. I felt really dizzy and nauseated, I felt like I could not walk. I felt like I hit by a bus. The next day I had heavy flu symptoms, high fever, continuous chest pain and high HR, at the ER they gave me a high dose of Benadryl, steroids and fluids. I took Benadryl for about 7 days and I still felt light headed palpitations and fever for almost 2 weeks. I also was tested for COVID and it was negative. I was advised to not take the second vaccine. I still have a really bad fatigue. It is the symptom that is still on and off.
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| 27 | 2021-01-12 | fatigue, headache, dizziness, fever |
Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headach...
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Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; This is a spontaneous report from a contactable health care professional. A 27-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number= EH9899, intramuscular, in left arm on 15Dec2020 at 18:45 (at the age of 27 years-old), as a single dose for COVID-19 immunization. The patient received the vaccination at a hospital. There was no medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was not reported if the patient took any other medications in the 2 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Dec2020, the patient experienced an instant headache, dizziness 2 hours after the injection, nausea/vomiting/diarrhea (N/V/D), fatigue, and a fever of 100.6. The patient was not hospitalized for the reported events and no treatment was given. The clinical outcome of the events of instant headache, dizziness 2 hours after the injection, nausea/vomiting/diarrhea, fatigue, and a fever of 100.6 was recovered on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19.
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| 27 | 2021-01-12 | fever, fatigue, headache |
Low grade fever (99.9), body aches, headache, fatigue. Took Tylenol. Symptoms lasted around 8 hour...
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Low grade fever (99.9), body aches, headache, fatigue. Took Tylenol. Symptoms lasted around 8 hours. Headache persisted all day.
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| 27 | 2021-01-12 | malaise, chills |
Malaise, chills, flushed, temperature of 99.1 with concurrent antipyretics (acetaminophen 1000mg PO ...
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Malaise, chills, flushed, temperature of 99.1 with concurrent antipyretics (acetaminophen 1000mg PO Q6H) starting approximately 20 hours post-vaccination
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| 27 | 2021-01-12 | fatigue, headache, dizziness |
Muscle tension all over body especially in neck, back, low back, and arms. Intense headache and fati...
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Muscle tension all over body especially in neck, back, low back, and arms. Intense headache and fatigue. Sore injection site, tender to the touch. Moments of Dizziness and zoning out.
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| 27 | 2021-01-12 | headache, chills, fatigue, fever |
Normal pregnancy other than anemia of pregnancy, EDD 02/18/21. Woke around 0030 with rigors, temp 10...
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Normal pregnancy other than anemia of pregnancy, EDD 02/18/21. Woke around 0030 with rigors, temp 103.5F, muscle aches, joint pain. Fever resolved with 1000mg Tylenol and hydration. Fevers continued with Tmax 102.5 for next 24 hours. Muscle aches, joint pain, headache, and fatigue persisted for about 36 hours total.
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| 27 | 2021-01-12 | throat swelling, shortness of breath |
PATIENT WAS WORKING HER SHIFT AT HOSPITAL ON 1/13/21 BUT WAS TOLD TO STOP WORKING AND VISIT THE COVI...
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PATIENT WAS WORKING HER SHIFT AT HOSPITAL ON 1/13/21 BUT WAS TOLD TO STOP WORKING AND VISIT THE COVID CLINIC WHEN HER REACTIONS STARTED. SHE APPEARED FLUSHED, AND WAS DEVELOPING A RASH ON BOTH HER ARMS, ITCHING. HER INJECTION SITE WAS RED AS WELL AS THE SURROUNDING AREA, ABOUT 1INCH IN DIAMETER. SHE REPORTS NO DIFFICULTIES BREATHING, BUT SOUNDED LIKE SHE WAS BREATHING A LITTLE ON THE HEAVIER SIDE. SHE SAID THAT IT FEELS LIKE THE LOWER HALF OF HER THROAT IS A BIT BIG AND STARTING TO SWELL. SHE WAS WALKED TO ED BY ANOTHER NURSE. ED MD FELT THE INJECTION SITE WAS INFECTED. PATIENT RECEIVED ANTIBIOTICS AND BENADRYL FOR THE ITCHING.
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| 27 | 2021-01-12 | chills, fever, fatigue, weakness | Pain in arm, difficulty moving arm, fever, chills, weakness, fatigue |
| 27 | 2021-01-12 | chills, fever |
Received 2nd dose Pfizer lot EL0142 on 1-12-2021 in left arm. She has been having fever, muscle ach...
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Received 2nd dose Pfizer lot EL0142 on 1-12-2021 in left arm. She has been having fever, muscle aches, arm pain and chills.
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| 27 | 2021-01-12 | dizziness |
Reported decreased sensitivity to touch in mouth and on face, mixing heat and cold (hot shower felt ...
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Reported decreased sensitivity to touch in mouth and on face, mixing heat and cold (hot shower felt cold, cold raindrops felt scalding, trouble thermoregulating) couldn't tell where arms were, dizziness, passed out.
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| 27 | 2021-01-12 | dizziness, headache, fatigue | Strong headache, muscle pain, fatigue, dizziness |
| 27 | 2021-01-12 | fatigue, malaise, shortness of breath |
This may not be related to the vaccine, but is strange enough that I'm reporting it. I got my vaccin...
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This may not be related to the vaccine, but is strange enough that I'm reporting it. I got my vaccine at around 3, and didn't have any immediate reaction. I have an exercise bike at home, and tried to work out but had to stop after only half an hour of very low effort biking because I couldn't get a deep breathe. usually I can bike for an hour at high intensity no problem and have never had to stop because I felt like I couldn't breathe. I woke up in the middle of the night feeling achy and unwell. When I woke up in the morning I was extremely fatigued and my eyes were itchy and puffy.
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| 27 | 2021-01-12 | headache, fever |
Within 8 hours of receiving dose #2 of COVID19 Pfizer, I experienced pain/stiffness at injection sit...
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Within 8 hours of receiving dose #2 of COVID19 Pfizer, I experienced pain/stiffness at injection site, body chills, body aches and a fever of 102 F. Symptoms subsided after Motrin was administered (in about an additional 8 hours to recover fever). Body aches, pain at injection site and lingering headache still present 24 hours after vaccination.
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| 27 | 2021-01-12 | fatigue, fever, sweating |
left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on n...
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left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on neck left side/right side/swollen lymph node on collar bone right side; pain in left side of her face; Fever; feel tired; felt like her body was hot; bump on head on left side; face was numb on left side; pimples to left eyebrows; possibly has shingles; This is a spontaneous report from a contactable consumer (patient). A 27 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) at her right arm at single dose for COVID-19 immunization on 29Dec2020. Relevant history included she had UTI, acne and dandruff which she had before the vaccine. Concomitant drug included clomifene citrate (CLOMID) since 30Dec2020 (5 days regimen). Past drug included she was taking Ampicillin 25mg prior to vaccine (last dose 2 days before vaccine). The patient experienced face was numb on left side since 02Jan2021. The patient also experienced pain in left side of her face, swollen lymph node on neck left side/neck right side, feel tired, felt like her body was hot, bump on head on left side, rash on head around bump on her left and fever since 03Jan2020. She took medication for fever. She felt good when take Motrin or Tylenol and then it came back again being tired. Then, the patient stated she sweat a lot since 04Jan2021, she had swollen lymph node on collar bone right side since 05Jan2021. The had left eyelid swollen since 06Jan2021. The patient also experienced pimples to left eyebrows that started Saturday or Sunday and possibly had shingles since unknown date in Jan2021. The patient went to the doctor because the doctor suggested that she had shingles and she had the shingles test on 06Jan2021, while she had not gotten the results back yet. The outcome of event Fever was recovered with sequel on 06Jan2021. Outcome of event possibly had shingles was unknown. The outcome of event she sweat a lot was Resolving. The outcome of other events was not resolved. The events pain in left side of her face, swollen lymph node on neck left side, rash on head around bump on her left, left eyelid swollen and pimples to left eyebrows was worsened.
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| 27 | 2021-01-12 | runny nose, headache, cough, chills |
muscle and joint pains that got progressively worse over the next 24 hours; muscle and joint pains t...
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muscle and joint pains that got progressively worse over the next 24 hours; muscle and joint pains that got progressively worse over the next 24 hours; body pain/body aches; I also have shaking chills; throbbing headache; tender anterior cervical lymphadenopathy; runny nose; dry cough; chest tightness; First dose of bnt162b2 on 18Dec2020/ second dose on 04Jan2021; This is a spontaneous report from a contactable physician (patient). A 27-year-old female patient (pregnant: No) received of bnt162b2 (Pfizer), via an unspecified route of administration in left arm on 04Jan2021 07:15 at single dose (second dose), via an unspecified route of administration in left arm on 18Dec2020 12:30 at single dose (first dose dose) for COVID-19 immunization. Medical history included asthma, allergies from an unknown date and unknown if ongoing. Allergies to medications, food, or other products was none. The patient's concomitant medications were not reported. Around 12 hours after the second dose, the patient started feeling muscle and joint pains that got progressively worse over the next 24 hours. She had to miss 1 work day so far due to body pain despite alternating taking ibuprofen and paracetamol (APAP) around the clock. It was now 48 hours after the vaccine, and she still have severe body aches. She also had shaking chills, throbbing headache, tender anterior cervical lymphadenopathy, runny nose, dry cough and chest tightness. Of note, she was a healthcare worker and tested negative for COVID PCR immediately after she received my second dose of the vaccine. She was tested due to a low-suspicion possible workplace exposure 5 days prior. She had no symptoms before the vaccine. The patient underwent lab tests and procedures which included nasal swab test: negative on 04Jan2021. The events were reported as non-serious. The adverse event didn't result in emergency room visit or physician office visit. No treatment received for the adverse event. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Birth control pills. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the had patient been tested for COVID-19. The outcome of events was resolving. Information about lot/batch number has been requested.
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| 27 | 2021-01-13 | fever, fatigue, chills |
After receiving my second dose of the Pfizer COVID-19 Vaccine on the morning of 1/13/21, I had arm s...
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After receiving my second dose of the Pfizer COVID-19 Vaccine on the morning of 1/13/21, I had arm soreness at the injection site. Later in the day, I experienced fatigue, which progressed to body chills and aches. Overnight, I developed a fever of 101.5 F. Fever was managed with ibuprofen taken throughout the following day, 1/13/21. On 1/13/21 at night, I had another fever of 101.6 F but did not taken any antipyretics before bed. On the morning 1/14/21 body aches, body chills, and fevers were resolved without antipyretics. Arm soreness still present on 1/14/21.
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| 27 | 2021-01-13 | headache | Body Aches, Headaches |
| 27 | 2021-01-13 | chills, headache | Chills, headache, general ache for 1 day. Lymphadenopathy for 3 days. |
| 27 | 2021-01-13 | chills, fever, headache, fatigue |
Chills; fever; body aches; headache; fatigue; This is a spontaneous report from a non-contactable ph...
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Chills; fever; body aches; headache; fatigue; This is a spontaneous report from a non-contactable pharmacist, the patient. This 27-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), dose 2, single dose via an unspecified route of administration in the right arm on 04Jan2021 at 06:15 PM (at the age of 27 years-old) for COVID-19 vaccination. There was no relevant medical history. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730), single dose, dose 1 in the left arm on 17Dec2020 at 12:00 PM and had injection site pain. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included oral contraceptives. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 05Jan2021 at 04:00 AM, the patient had chills, fever, body aches, headache, fatigue. The events were reported as non-serious. The onset was roughly 10 hours after dose. All symptoms apart from fatigue resolved between 36 and 48 hours after dose. The patient was treated for fever and muscle aches with over the counter (OTC) ibuprofen. The clinical outcome of chills, fever, body aches, headache was recovering and not recovered from fatigue. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 27 | 2021-01-13 | chills, fatigue | Fatigue, body aches, nausea, chills. Improving. |
| 27 | 2021-01-13 | fatigue, fever | Fever 99.8F, body aches, fatigue |
| 27 | 2021-01-13 | chills, headache, fatigue, fever | Fever, bodyaches, chills, headache and fatigue |
| 27 | 2021-01-13 | dizziness, chills, headache, cold sweat, fever |
Fever, chills, nausea, light sensitivity, sound sensitivity, headache, dizziness, cold sweats, dry m...
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Fever, chills, nausea, light sensitivity, sound sensitivity, headache, dizziness, cold sweats, dry mouth all lasting over 36 hours.
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| 27 | 2021-01-13 | cough, respiratory tract congestion, fever, throat pain, chills |
Fever, sore throat, chills, congestion, cough, nausea, muscle aches, tachycardia. Treatment: Tylenol...
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Fever, sore throat, chills, congestion, cough, nausea, muscle aches, tachycardia. Treatment: Tylenol with no improvement Outcome: referred for COVID testing
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| 27 | 2021-01-13 | malaise, fever |
Fever; myalgia; malaise; This is a spontaneous report from a contactable Physician (patient). A 27-y...
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Fever; myalgia; malaise; This is a spontaneous report from a contactable Physician (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), intramuscular (vaccination location: left arm) on 18Dec2020 13:15 at SINGLE DOSE for COVID-19 immunisation. Medical history included COVID-19 (reported as prior to vaccination, patient was diagnosed with COVID-19) from an unknown date and unknown if ongoing. The patient has not received other vaccines within four weeks prior to COVID vaccine and no other medications received within two weeks of vaccination. The patient's concomitant medications were not reported. The patient has no known allergies. On 19Dec2020, the patient experienced fever, myalgia, and malaise. It was reported that patient received paracetamol (TYLENOL) for fever. It was reported that since vaccination, the patient has been tested for COVID-19 with PCR swab test on 28Dec2020 which had negative results. Outcome of the events was recovered. Information on the Lot/batch number has been requested.
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| 27 | 2021-01-13 | weakness, fatigue, dizziness, headache |
Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, and seeing dark spots (dat...
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Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, and seeing dark spots (date/time of onset symptoms 1/13/2021 at 3:00PM) Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, swollen lymph nodes, and hard to swallow ( date/time of onset symptoms 1/13/2021 at 4pm and still ongoing).
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| 27 | 2021-01-13 | headache, sweating |
Hives on chest, neck, and face, headache, diaphoresis five min after COVID vaccine A & O x4, ambulat...
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Hives on chest, neck, and face, headache, diaphoresis five min after COVID vaccine A & O x4, ambulates. Administered Benadryl 50mg PO. symptoms persist after 20min. Called 911, evaluated and transported to Emergency Dept.
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| 27 | 2021-01-13 | migraine |
I received my 2nd shot 1/12 @3:30pm. 1/13 @5:00 I started having severe stomach cramps, a migraine, ...
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I received my 2nd shot 1/12 @3:30pm. 1/13 @5:00 I started having severe stomach cramps, a migraine, and vomiting that is still occurring 1/14 @ 8:10 am.
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| 27 | 2021-01-13 | headache, chills, fever |
Onset 12 hours after injection of alternating fever and chills, nausea, vomiting, myalgias, arthralg...
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Onset 12 hours after injection of alternating fever and chills, nausea, vomiting, myalgias, arthralgia, and headache.
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| 27 | 2021-01-13 | headache, shortness of breath |
Sudden severe arm and shoulder pain (left side) along with severe neck pain. I was unable to move my...
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Sudden severe arm and shoulder pain (left side) along with severe neck pain. I was unable to move my neck for about an hour. As well as left sided facial pain. Worst migraine of my life. Right leg/foot spasms. Heart palpitations, difficulty catching breath, Following day-moderate neck pain, headache, and very sore left arm, nausea, left shoulder pain
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| 27 | 2021-01-13 | dizziness | Systemic: Light headedness and dizziness-Medium |
| 27 | 2021-01-13 | fatigue, fever, headache |
The morning after getting the 2nd COVID-19 vaccination, I walked to work and started to feel more fa...
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The morning after getting the 2nd COVID-19 vaccination, I walked to work and started to feel more fatigued than usual within about 40 minutes after starting to walk from my apartment at 0600. I had a hard time staying awake, started to become flushed and feeling feverish at 0700 at work, and began to develop a headache and nausea around 0745. I went to sick call on my ship after realizing I couldn't power through the symptoms around 0800, and my Senior Chief mentioned earlier in the report) sent me home with motrin, tylenol, and mucinex for any congestion that may come up. Today (14JAN21) I seem to be a little more active and have an easier time staying awake, the headache and nausea have dissipated completely. However, I am still feeling more fatigued than I have been lately, and I began to feel flushed and feverish again around the same time in the morning.
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| 27 | 2021-01-13 | shortness of breath, dizziness |
When I received my first dose of the Pfizer COVID shot I had no issues. When I received the second d...
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When I received my first dose of the Pfizer COVID shot I had no issues. When I received the second dose I had the vaccine injected and then I got up and walked to the monitoring room where we sit for 15 minutes. Immediately upon sitting down in that room I felt very woozy, lightheaded, and my heart was beating out of my chest. I checked my pulse on my smart watch and it was in the 80s but my resting HR is normally in the 60s or 70s. I got nervous at that point so I took some deep breaths and tried to relax and my symptoms improved within a minute. I sat for the remainder of the monitoring period and right at my 15 minute mark all of my symptoms returned. HR in the 100s, lightheaded like I was going to pass out, chest heaviness, and shortness of breath. I alerted the nurse in the monitoring room and she took my BP and HR and they have me a bottle of water. My throat felt a little weird too and I was worried that it was starting to close up, but I was able to swallow water normally. I remained in the monitoring room for about 15 more minutes and at that point my symptoms mostly resolved and I felt well enough to leave. For the next approx 48 hours I have had some mild- moderate chest heaviness. More worse in the initial 24-36 hours after the vaccination.
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| 27 | 2021-01-13 | malaise, fever, chills |
fever and chills; fever and chills; blood pressure was low, about 90/50; did not feel well; syncope ...
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fever and chills; fever and chills; blood pressure was low, about 90/50; did not feel well; syncope episode; unconscious; This is a spontaneous report from a contactable other health professional. A 27-year-old non-pregnant female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration in the left arm on 08Jan2021 at 12:00 at a single dose for COVID-19 immunization; received at a nursing home/senior living facility. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Medical history included COVID-19 from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included unspecified birth control taken for an unspecified indication from an unknown date to an unknown date; within two weeks of vaccination. The patient experienced the following events and outcomes: syncope episode in Jan2021 with outcome of unknown, unconscious in Jan2021 with outcome of unknown, fever and chills on 09Jan2021 with outcome of unknown, blood pressure was low, about 90/50 on 09Jan2021 with outcome of unknown, did not feel well in Jan2021 with outcome of unknown; all of which were assessed as medically significant. The clinical course was reported as follows: the fever and chills began about one hour after vaccination (as reported). About 18 hours after the vaccination, the patient was getting up to take more paracetamol (TYLENOL) and did not feel well. The patient had a syncope episode in the bathroom (no issues as she sat on the floor before hand). The patient was unconscious for about 1-2 minutes. The patient's blood pressure several minutes later was low, about 90/50; however, the patient took the blood pressure measurement herself, so it may not have been exactly accurate. The patient underwent lab tests and procedures which included blood pressure measurement: low, about 90/50 on 09Jan2021. Therapeutic measures were taken as a result of fever. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all reported serious events cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 27 | 2021-01-14 | nasopharyngitis |
After about 2 hours l arm felt tight and swollen, woke up in the night with severe arm pain, could n...
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After about 2 hours l arm felt tight and swollen, woke up in the night with severe arm pain, could not lift arm to dress pain continued to increase, felt like a circulation issue = numb, cold, limp contacted employee heatl
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| 27 | 2021-01-14 | shortness of breath | Anaphylaxis- throat closing, feels SOB 15 minutes after vaccine. |
| 27 | 2021-01-14 | headache, chills |
Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; ...
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Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 14:00 at a single dose on left arm for COVID-19 immunization. The patient's medical history was not reported. No known allergies. Concomitant medication included drospirenone, ethinylestradiol (YASMIN) for birth control. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 21Dec2020 08:00 at a single dose on left arm for COVID-19 immunization. The patient experienced body aches, chills, headache, nausea - emesis x1 on 08Jan2021 02:00. No treatment received for adverse event. The outcome of the events was recovering. The events were assessed as non-serious. Facility type vaccine was Hospital. No other vaccine received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 27 | 2021-01-14 | night sweats, chills | Body aches, chills, joint pain, night sweats |
| 27 | 2021-01-14 | fever, chills | Chills, fevers up to 101 degrees Fahrenheit, severe myalgias, loss of appetite |
| 27 | 2021-01-14 | nasopharyngitis |
Left arm unusually tight and swollen about 2 hours after injection. Woke up that night in severe pa...
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Left arm unusually tight and swollen about 2 hours after injection. Woke up that night in severe pain. Unable to life arm to dress next morning. Increasing pain, felt like a circulation problem - cold, numb, limp used ice and tylenol and aleve, day two slightly better
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| 27 | 2021-01-14 | fatigue |
Patient presented to emergency department with nausea, diarrhea, fatigue, and body aches. Patient wa...
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Patient presented to emergency department with nausea, diarrhea, fatigue, and body aches. Patient was given phenergan with resolution of symptoms. Patient was discharged home in stable condition
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| 27 | 2021-01-14 | weakness, shortness of breath | Seizure like reaction after COVID-19 vaccine, experienced weakness and shortness of breath. |
| 27 | 2021-01-14 | chills, headache, cough | Severe headache, chills and cough |
| 27 | 2021-01-14 | sweating, headache, chills, body temperature increased | Severe myalgia, temp 101.8, chills and sweating, headache, nausea and vomiting |
| 27 | 2021-01-14 | chills, fatigue, fever |
Shortly after the dose, I had fatigue Over the next 12-36 hours, I experienced full body aches, extr...
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Shortly after the dose, I had fatigue Over the next 12-36 hours, I experienced full body aches, extreme fatigue, fever and chills Had to call in sick for work It resolved after 48 hours
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| 27 | 2021-01-14 | shortness of breath | Systemic: shortness of breathe, 100-120 bpm,150/80bpm-Medium |
| 27 | 2021-01-14 | headache |
arm soreness (minor) day after; Headache (minor) day of; This is a spontaneous report from a contact...
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arm soreness (minor) day after; Headache (minor) day of; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1618; expiry date: unknown) via an unspecified route of administration (left arm), on 07Jan2021 at 12:15, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient has no known allergies (NKA). Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), naproxen sodium (NAPROSYN). It was unknown if the patient is pregnant at the of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 07Jan2021, at 13:00, the patient experienced headache (minor) day of. The patient experienced arm soreness (minor) day after (08Jan2021). The patient received naproxen as treatment for the events. Outcome of the events was recovered.
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| 27 | 2021-01-14 | chills, fatigue, headache |
chills, headache, fatigue, generalized aches, intermittent nausea (no emesis) -all symptoms lasting...
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chills, headache, fatigue, generalized aches, intermittent nausea (no emesis) -all symptoms lasting around 24 hours at this time
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| 27 | 2021-01-14 | fatigue, headache |
the day after woke up with a headache and muscle pain that continued to last. for the last two weeks...
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the day after woke up with a headache and muscle pain that continued to last. for the last two weeks I have also had tachycardia and extreme fatigue, on top of the muscle pain and headaches.
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| 27 | 2021-01-15 | discomfort |
I had a mildly sore arm on Saturday 1/9/21. I awoke Sunday 1/10/21 and had suspected axillary lympha...
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I had a mildly sore arm on Saturday 1/9/21. I awoke Sunday 1/10/21 and had suspected axillary lymphadenopathy on the same arm as my injection. No palpable lymph nodes on affected armpit. Mild discomfort with palpating the edema in the affected armpit. Took 600mg ibuprofen. Swelling continued into Monday 1/11/21, but had decreased in size
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| 27 | 2021-01-15 | chills, fever |
Pfizer-BioNTech COVID-19Vaccine Side effects of chills, low-grade fever, myalgia began at 6:00 PM o...
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Pfizer-BioNTech COVID-19Vaccine Side effects of chills, low-grade fever, myalgia began at 6:00 PM on the evening of receiving a vaccine. Side effects were subjectively worse than after first dose (12/22/2020). Side effects continued the following day and night and resolved two days later on the morning of 1/14/2021.
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| 27 | 2021-01-15 | chills, fever |
Pfizer-BioNTech COVID-19Vaccine EUA Low-grade fever, chills, myalgia beginning around 8:00PM on the...
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Pfizer-BioNTech COVID-19Vaccine EUA Low-grade fever, chills, myalgia beginning around 8:00PM on the evening of vaccination. Symptoms resolved by morning.
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| 27 | 2021-01-15 | chills, fever, headache, fatigue | Stomach pain, chills, low grade fever, body aches, joint pains, headache, hot flashes, fatigue |
| 27 | 2021-01-15 | throat irritation |
Vaccinated at 8:55am, Per Nurse Practitioner note patient started experiencing itching upper chest, ...
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Vaccinated at 8:55am, Per Nurse Practitioner note patient started experiencing itching upper chest, medicated with Benadryl P.O., started with throat itching, medicated with Benadryl IM, EPI IM, EMS called, placed on O2, diminished breath sounds bases, slight stridor, EPI IM, Solumedrol IM, EMS transported to local ED. Patient called NP later in day and said she was admitted to the hospital.
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| 27 | 2021-01-16 | headache |
Around 6:00pm I started getting very severe upper abdominal cramps, and a headache. I was unable to ...
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Around 6:00pm I started getting very severe upper abdominal cramps, and a headache. I was unable to do anything except lay down. Its currently 12:12am and I still have both symptoms.
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| 27 | 2021-01-16 | dizziness, chills, sweating |
Awoke with chills and very hot. Walked to bathroom to take Advil. Took 600mg Advil became nauseous a...
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Awoke with chills and very hot. Walked to bathroom to take Advil. Took 600mg Advil became nauseous and dizzy, sat down and became more dizzy and had loss of vision. Then laid down and a very moments later was able to sit back up. Was very sweaty and with tinnitus which lasted about 10 minutes and then Resolved itself.
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| 27 | 2021-01-16 | fever, chills, headache | headache, chills, fever, body aches/ muscle soreness after 2nd dose |
| 27 | 2021-01-17 | dizziness, fever |
Lightheadedness Fever, despite Tylenol (101.3) Muscle pain - primarily in lower back and quads Joint...
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Lightheadedness Fever, despite Tylenol (101.3) Muscle pain - primarily in lower back and quads Joint pain - ankles, knees, hips
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| 27 | 2021-01-17 | fatigue, influenza like illness |
Received shot Wednesday night, developed arm soreness and mild flu like symptoms on left side of my ...
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Received shot Wednesday night, developed arm soreness and mild flu like symptoms on left side of my body and facial paresthesias on the left side of my face. Twelve hours later, after waking up those same symptoms were only on the right side of my body. Friday morning, mostly normal physically just with some overall fatigue. Friday afternoon I started to get hives on my chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until Monday mid-day when Benadryl was not helping reduce the hives and so I had full body hives. I did try an drugstore cortisone cream which did not help. Sought treatment at an urgent care as I was feeling anxious and could not control the itching. I and was diagnosed with likely allergic reaction to the covid-19 vaccine.
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| 27 | 2021-01-17 | headache, lethargy, fever, chills |
profound headache; resembling meningitis: could not turn neck from side to side; resembling meningit...
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profound headache; resembling meningitis: could not turn neck from side to side; resembling meningitis: could not turn neck from side to side; pressure behind eyes when moving eyes quickly; profound body aches, primarily in the lower back; profound body aches, primarily in the lower back; 100.2-101.0 fever; chills; lethargy; This is a spontaneous report from a contactable Nurse reported for self. A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: EL1284), via an unspecified route of administration in left arm on 09Jan2021 18:30 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication included influenza vaccine inact split 4v (AFLURIA QUAD), desogestrel, ethinylestradiol (APRI). The patient experienced profound headache, resembling meningitis: could not turn neck from side to side, pressure behind eyes when moving eyes quickly. -profound body aches, primarily in the lower back. -100.2-101.0 fever -chills -lethargy on 10Jan2021 12:00. Patient had Rapid nasal swab with negative result on 26Oct2020. Outcome of events was recovering.
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| 27 | 2021-01-18 | headache, malaise |
Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to ...
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Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe malaise; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; loss of appetite; Transient dysgeusia; Mild nausea; Pleuritic chest pain; This is a spontaneous report from a non-contactable physician. This 27-year-old female physician (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=E15249), via unspecified route at left arm on 08Jan2021 07:30 AM at single dose for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization. Facility type of vaccine was hospital. No other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination. On 08Jan2021 06:00 PM, patient experienced severe headache from 12-36h post administration (as reported), impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia (nearly meningeal signs); mild nausea; pleuritic chest pain; severe malaise; transient dysgeusia; loss of appetite. Treatment for events included initially NSAIDs until had difficulty tolerating was received. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 27 | 2021-01-19 | fatigue, chills, fever | 1/14 woke up with chills, fatigue, fever 101 |
| 27 | 2021-01-19 | dizziness, sweating, skin warm |
1410 Client became light headed and reported to obs desk. Unassisted descent to floor upon turning ...
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1410 Client became light headed and reported to obs desk. Unassisted descent to floor upon turning to go to a 30 min obs seat. Did not strike head, sat on buttocks and propped self with left arm; No medical Hx. BP 140/100 P 96 R 12 SpO2 100%; LOC A&O x3, did not lose consciousness; skin warm pink and sweaty; hot at back of neck; HR regular; Resps unlabored; Lungs clear; assisted to a supine on floor and legs elevated; ice pack for comfort; EMS notified 1420 BP 152/104 P 70 R 12 SpO2 99% Resps continued unlabored; EMS arrived; Handoff report given; EMS assessed; client sitting; ; client offered transport to local ED and declined 1430 Client moved back into chair; BP 136/94 P 94 R 12 SpO2 99% 1440 Client stated she was starting to feel light headed again. Moved to floor and legs elevated again. BP 140/90 P 87 R10; Resps unlabored; A&O x3; skin cool pink dry; 1445 BP 136/108 P 85 R 10 ; continues supine with legs elevated; requested that client find someone to drive her home rather than drive self; client contacting boyfriend 1450 BP 140/108 Client states she feels fine but would like to remain on the floor sitting up. 1500 Client moved to chair for further observation; VS assessment discontinued 1530 Client remains in obs and waiting for ride
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| 27 | 2021-01-19 | fatigue, fever |
Approximately 12 hours after vaccine dose: fever that lasted for 48 hours, fatigue, and extreme swel...
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Approximately 12 hours after vaccine dose: fever that lasted for 48 hours, fatigue, and extreme swelling of lymph nodes in throat, armpit, and groin. Swelling in lymph nodes of arm that received vaccine was so severe that I could not let my arm rest down by my side without throbbing pain. Pain went away after about 48-72 hours but swelling persisted for 1 week.
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| 27 | 2021-01-19 | headache, runny nose, chills, body temperature increased | Chills, body aches, runny nose, Headache, Temperature 99.4, lymph node swollen and tinnitus. |
| 27 | 2021-01-19 | headache | Continuous severe headache, body ache, swollen lymph nodes, low grade fever (97.7 F) |
| 27 | 2021-01-19 | fever, fatigue, headache | Fever, body aches, fatigue, sensitive to touch, headache |
| 27 | 2021-01-19 | fever, headache |
I had side effects (fevers, myalgias, headaches) the day after. However, starting Saturday 1/9 I beg...
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I had side effects (fevers, myalgias, headaches) the day after. However, starting Saturday 1/9 I began having urticaria all over my body. I took Benadryl 4 times over the course of the day, and the rash goes away but comes back. Went to Urgent Care on Sunday. Advised to take Benadryl and Pepcid
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| 27 | 2021-01-19 | headache |
I started having body aches, arm soreness and a headache about 15 hours after I got my 2nd vaccine....
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I started having body aches, arm soreness and a headache about 15 hours after I got my 2nd vaccine. My symptoms lasted about 12 hours and I feel completely fine now.
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| 27 | 2021-01-19 | dizziness |
Patient had onset of symptoms within five minutes of the vaccination, felt rapid heart rate and dizz...
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Patient had onset of symptoms within five minutes of the vaccination, felt rapid heart rate and dizzy. Had patient lay down, monitored VS every 10 minutes. 1750 - BP 114/70, P 85, R18, O2 100 1800 BP 127/65, P78, R16, O2 100. Drinking water. After 10 minutes heart rate felt better but c/o itching, flushed chest. Gave oral Benadryl 25mg liquid. VS 1810 BP 120/67, P 70, R 16, O2 100%. VS at 1830 BP 115/61, P70, R 15, O2100%
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| 27 | 2021-01-19 | fever, headache, dizziness |
Severe pain in temples and jaw, pain at hips, nausea and vomiting, low-grade fever (highest was 100....
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Severe pain in temples and jaw, pain at hips, nausea and vomiting, low-grade fever (highest was 100.1 degrees F), dizziness.
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| 27 | 2021-01-20 | fever |
I woke up at 4am to my heart racing. I am a nurse so I checked my pulse and it was 126. I tried to b...
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I woke up at 4am to my heart racing. I am a nurse so I checked my pulse and it was 126. I tried to bear down at home to decrease my heart rate but it continued to climb to 164 so after an hour of sustained Hr 126-164 I went to the emergency room where I had SVT. They did a valsalva maneuver 3 times and that made my heart rate go down to the 130s. It was then sinus tachycardia and stayed 120s-130s until about noon. Upon discharge at 3:30pm my resting heart rate was still 105 but it was determined to be a vaccine reaction as all other tests were normal.
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| 27 | 2021-01-20 | headache, fatigue, chills |
She is 11 weeks pregnant EE received 2nd covid vaccine on 1/19 at 0727 and began having s/s 1/20 at...
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She is 11 weeks pregnant EE received 2nd covid vaccine on 1/19 at 0727 and began having s/s 1/20 at 1400: HA, body aches, chills, fatigue.
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| 27 | 2021-01-21 | fatigue, headache, fever |
12 hours after injection, I experienced fatigue, muscle aches/tension, headache, a low-grade fever l...
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12 hours after injection, I experienced fatigue, muscle aches/tension, headache, a low-grade fever lasting approximately 9 hours. Self-treated with ibuprofen. Symptoms were 100% resolved within 24 hours of vaccination.
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| 27 | 2021-01-21 | fever |
3AM 1/13 WOKE UP WITH FEVER 12PM 1/13 VOMIT. ALL DAY FEVER, MUSCLE PAIN TOOK TYLENOL 1 GRAM @ 4AM 1/...
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3AM 1/13 WOKE UP WITH FEVER 12PM 1/13 VOMIT. ALL DAY FEVER, MUSCLE PAIN TOOK TYLENOL 1 GRAM @ 4AM 1/13 12PM 1/13, 10PM 1/13
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| 27 | 2021-01-21 | shortness of breath, cough |
Approx 3 -5 minutes after vaccine -redness and hives on both arms, chest, and face. Approximately 10...
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Approx 3 -5 minutes after vaccine -redness and hives on both arms, chest, and face. Approximately 10 minutes after vaccine- cough, shortness of breath, tongue itchy, lips swelling. Epi pen in L thigh, 50 mg benedryl IM in R deltoid. Brought to emergency room, 1 liter normal saline, pepcid, solu-medrol, 25mg benadryl IV. D/c to home around noon. 1/22/2020- secondary anaphylactic reaction at 945am. Epi pen to r thigh, 50mg PO benadryl, 20mg prednisone. Drove to hospital ER received 1 liter of normal saline, pepcid, 25mg benadryl IV, 40mg prednisone. D/C at 3pm on prednisone taper.
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| 27 | 2021-01-21 | headache, fever, chills, fatigue |
Chills, headache, nightmares, low fever, plantar fasciitis, shaking, low 02(94), high pulse (120), m...
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Chills, headache, nightmares, low fever, plantar fasciitis, shaking, low 02(94), high pulse (120), muscle pain, eye pain, fatigue, fogginess
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| 27 | 2021-01-21 | headache, fatigue | Fatigue, headache, nausea. Improved. |
| 27 | 2021-01-21 | chills, headache | Headache with sensitivity to sound and chills, Ibuprofen 400 mg q6 hours for 24 hours |
| 27 | 2021-01-21 | shortness of breath |
Heart rate elevated to 150 and above, shortness of breath. Went to emergency room. Admitted with blo...
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Heart rate elevated to 150 and above, shortness of breath. Went to emergency room. Admitted with blood clot in lung. Previously had COVID in 2020, and we are unsure if this is related to previous illness.
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| 27 | 2021-01-21 | weakness |
Neuropraxia of Left Arm; A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING...
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Neuropraxia of Left Arm; A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS This is a report from an interventional study source for Protocol C4591001 sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. The subject is in open-label phase of the study when the event occurred. A 27-year-old female with a medical history of seasonal allergies (Mar2006 and ongoing not taking any medications to treat) who received the first dose of blinded therapy (BNT162;PLACEBO) (dose 1) on 14Aug2020 at 10:34, second dose of blinded therapy (BNT162;PLACEBO) (dose 2) on 04Sep2020 at 09:27. The first dose of BNT162B2 (dose 3) on 23Dec2020 at 09:25, and the second dose of BNT162B2 (dose 4) on 11Jan2021 at 09:48. All intramuscularly in the left deltoid as a single dose for COVID-19 immunization. Concomitant medications included ethinyl-estradiol/norethisterone acetate (LOESTRIN) for birth control from May2014 and ongoing. There was no family medical history relevant to AE and no concomitant vaccine administered on the same date of investigational vaccine or other prior vaccine within four weeks. The subject experienced neuropraxia of left arm on 11Jan2021 at 09:51 considered an important medical event requiring a visit to physician office. The clinical course was the following: At 9:51, 3 minutes after receiving the second dose of BNT162B2 in left deltoid, the subject complained of left arm numbness and tingling starting at elbow and extending to fingers, weakness, and a weak grip in that hand. She also reported a decreased range of motion on the left side including her arm, shoulder joint, elbow, wrist, and metacarpophalangeal. Subject was afebrile with a normal vascular exam, no bruising, capillary refill time was less than 3 seconds. No antipyretic medication was administered. The investigator requested the subject to return to site the following day. On 12Jan2021, the investigator noted some improvement to symptoms but the subject was unable to return to work for several days after event. An appointment was scheduled with a neurologist for 13Jan2021. The action taken with BNT162B2 for the event was not applicable. The clinical outcome of the event was recovering. The investigator considered there was a reasonable possibility that the event neuropraxia of left arm was related to the second dose of BNT162B2 (dose 4) and clinical trial procedure (vaccination administration in the left deltoid, investigator did consider the location was appropriate), but unrelated to first and second dose of blinded therapy (BNT162;PLACEBO), first dose of BNT162B2 (dose 3) or concomitant medications. Per investigator, it was not likely that the event was related to the investigational product (IP) itself, however, that could not be 100% determined until neurologist had evaluated the subject.; Sender's Comments: The event "Nerve Injury" is unlisted in the Single Reference Safety Document (SRSD) of the Investigational Product therapy vaccine (BNT162B2). There is a reasonable possibility for the event "Nerve Injury" to be related to the procedure of vaccine (BNT162B2) administration (needle trauma) rather than to the product administered. The event would not be considered a unique response to this specific vaccine (BNT162B2). The case will be reassessed upon reception of neurological advice. Pfizer's safety database was reviewed for cases reporting PF-07302048 or blinded therapy through 31-DEC-2020 for adverse events encoding to MedDRA (v.23.1J) Preferred Term(s) of Nerve injury. Review of the database for the PT Nerve injury had the following results: 0 serious clinical trial cases and 1 non-clinical trial case. The impacts of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committee and Investigators, as appropriate.
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| 27 | 2021-01-21 | cough, shortness of breath |
Patient developed diffuse rash on 01/20/2021, 2 weeks after COVID-19 vaccine administered on 0/06/20...
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Patient developed diffuse rash on 01/20/2021, 2 weeks after COVID-19 vaccine administered on 0/06/2021. Rash erythematous and raised with no hives. Rash started on chest and has spread to bilateral arms, bilateral legs, and back. Face, palms, and soles spared. Reports cough and shortness of breath for an hour when rash first appeared that resolved and has no returned. Since rash has started has taken OTC Benadryl every 6-8 hours. Patient presented on 01/22/2021 for evaluation of the rash.
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| 27 | 2021-01-21 | cough, shortness of breath |
Patient received vaccine on 01/06/2021 and developed a diffuse rash on 01/20/2021. Rash started on t...
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Patient received vaccine on 01/06/2021 and developed a diffuse rash on 01/20/2021. Rash started on the chest and then spread to the bilateral arms, bilateral legs, and her back. Her face, palms, and soles are spared. Rash is mildly pruritic and not painful. Patient reports at the time the rash started she had a cough and SOB for 1 hour that has resolved and not returned. Patient has been taken OTC Benadryl PRN every 6-8 hours since the rash presented. Patient presented to Clinic for evaluation on 01/22/2021.
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| 27 | 2021-01-21 | fever | Reported chest tightness, muscle aches, and fever 101.3 |
| 27 | 2021-01-21 | fatigue |
tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-spo...
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tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patients mother) reported for a 27-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685), via an unspecified route of administration in the left arm on 17Dec2020 at single dose, for Covid-19 immunisation. Medical history included was sick 4-5 days in Feb2020 or Mar2020. There were no concomitant medications. After the 1st dose, the patient had fatigue after the 3rd day. After a week she felt like she had loose motions in other words diarrhea. She lost her smell and taste both (thought it was 27Dec2020). She got herself tested and it was positive. She tested positive on 28Dec2020. The outcome of event was unknown.
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| 27 | 2021-01-22 | malaise | I was pregnant and my baby died two days after I took it and I got really sick |
| 27 | 2021-01-24 | shortness of breath |
within minutes after my shot, I started to have difficulty swallowing. i was monitored for 30 minute...
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within minutes after my shot, I started to have difficulty swallowing. i was monitored for 30 minutes at the vaccine site before being escorted to the medical observation area. While in the medical observation area I tried to take a sip of water but could not swallow it. At that moment I began having a tight feeling in my chest. I began to hyperventilate followed by difficulty breathing or talking. This was accompanied by feelings of impending doom, and uncontrollable trembling and inability to concentrate on what the medical observation area Doctor was saying. The time from the drink of water until I was able to breathe, speak, and concentrate normally was about 20 minutes. Tightness in my chest has improved but not fully recovered. General malaise and headache have developed.
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| 27 | 2021-01-25 | fever, headache | Body aches, low grade fever, nausea, vomiting, diarrhea, HA, arm soreness |
| 27 | 2021-01-25 | headache, chills | Chills, full body aches, headache, upset stomach |
| 27 | 2021-01-25 | fatigue, fever |
Fatigue; body aches; Low grade fever; This is a spontaneous report from a contactable other healthca...
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Fatigue; body aches; Low grade fever; This is a spontaneous report from a contactable other healthcare professional. A 27-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection; lot/batch number and expiration date were unknown), intramuscularly on the left arm on 23Dec2020 and second dose, via an unspecified route of administration on 13Jan2021 (lot/batch number and expiration date were unknown); both at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included COVID-19 on an unknown date prior vaccination. The patient had no known allergies. There were no concomitant medications. The patient was not pregnant. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient had not tested for Covid post vaccination. On 24Dec2020, the patient experienced fatigue, body aches, and low grade fever. The patient did not receive any treatment for the events. The patient recovered from all the events on an unspecified date. Information on the lot/batch number has been requested.
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| 27 | 2021-01-26 | throat pain, cough, fatigue |
After my shot I felt fatigued and body aches I slept most of the day and hydrated myself. The next d...
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After my shot I felt fatigued and body aches I slept most of the day and hydrated myself. The next day when I got up I had full blown sinus problems, headache, congestion, cough (progressed over a couple of days), throat and nasal pain/soreness. I felt that way until about the 01/02 or 01/03 and I was on antibiotics and fluids during this time period.
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| 27 | 2021-01-26 | dizziness, throat pain, chills, fever, headache |
Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at i...
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Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; This is a spontaneous report from a contactable other hcp. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9x31 and expiry date unknown), intramuscular on the right arm on 05Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included pneumonia, bronchitis and sinusitis from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), fish oil (FISH OIL) and olly womans multivitamin. The patient experienced dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site and chills on 06Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jan2021. Therapeutic measures were taken as a result of the events. The patient was advised to rest for 2 days and take Tylenol. The outcome of the events was recovered with sequelae.
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| 27 | 2021-01-26 | dizziness |
Felt dizzy and jittery and flushed. HR elevated by NSR. Monitored for greater than 1 hour with sym...
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Felt dizzy and jittery and flushed. HR elevated by NSR. Monitored for greater than 1 hour with symptoms occurring on and off during that period. At 1025 she felt flushed again with report of scratchy throat. No distress noted. Oxygen sats 100%. No itching or hives noted. No swelling of the face or airway but since she continued to have symptoms she was placed in wheelchair and taken to the ER.
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| 27 | 2021-01-26 | nasal congestion, cough | I had a cough for two days that got worse, nasal congestion & body aches. |
| 27 | 2021-01-26 | headache |
Mild headache. Took 600mg ibuprofen after an hour, and pain quickly subsided. Has not returned. No o...
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Mild headache. Took 600mg ibuprofen after an hour, and pain quickly subsided. Has not returned. No other effects.
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| 27 | 2021-01-26 | chills |
Sore arm for 3 days, chills for 7 hours, and uncontrollable lower back, hip joint, legs and neck pai...
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Sore arm for 3 days, chills for 7 hours, and uncontrollable lower back, hip joint, legs and neck pain/ache for 24 hours straight.
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| 27 | 2021-01-26 | chills, fever | fever, body aches, chills, nausea |
| 27 | 2021-01-26 | chills, fever, fatigue, sweating |
sweating; chills; fever; major fatigue; Major hair loss starting 1.5 days following the vaccination;...
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sweating; chills; fever; major fatigue; Major hair loss starting 1.5 days following the vaccination; This is a spontaneous report from a contactable other health care professional. A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), intramuscular on 12Jan2021 16:30 at SINGLE DOSE at Arm Left for covid-19 immunisation. Medical history included covid-19; covid prior vaccination: yes. Concomitant medication included escitalopram oxalate (LEXAPRO). Major hair loss starting 1.5 days following the vaccination on an unspecified date in Jan2021, in addition to sweating, chills, fever, and major fatigue on 13Jan2021 22:30. The patient did not receive treatment for the events. The outcome of the events was not recovered.
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| 27 | 2021-01-27 | sweating, chills | Excessive sweating, chills, nausea overnight, about 6 hours |
| 27 | 2021-01-28 | headache, chills, fever, fatigue |
Chills, body aches, fever, fatigue, headache; 48 hrs duration; treated withTylenol 650 mg alternated...
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Chills, body aches, fever, fatigue, headache; 48 hrs duration; treated withTylenol 650 mg alternated with Ibuprofen 1000mg
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| 27 | 2021-01-28 | nasal congestion, cough, headache, throat pain |
Feeling hot and flushed then suddenly so cold I was shaking. Massive headache, body aches, sore thro...
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Feeling hot and flushed then suddenly so cold I was shaking. Massive headache, body aches, sore throat, cough, congestion, and sinus pressure.
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| 27 | 2021-01-31 | throat swelling, chills, headache, dizziness |
Headache right after vaccine was administered. Approximately 40min after vaccine was administered I...
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Headache right after vaccine was administered. Approximately 40min after vaccine was administered I had severe dry mouth, inability to swallow, at about an hour after vaccine was administered my lips tongue and throat were swelling. Diarrhea, chills, dizziness, severe tremors.
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| 27 | 2021-02-13 | throat swelling, shortness of breath |
Anaphylaxis. Hives, anterior/posterior throat swelling, shortness of breath. Resolved with epinephri...
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Anaphylaxis. Hives, anterior/posterior throat swelling, shortness of breath. Resolved with epinephrine drip, receiving three epinephrine injections and Benadryl from EMS. Likely will be kept for observation given epi drip.
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| 27 | 2021-02-17 | dehydration, discomfort |
fever 120; vomit to dehydration point; vomit to dehydration point; a lot of discomfort; hot feeling ...
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fever 120; vomit to dehydration point; vomit to dehydration point; a lot of discomfort; hot feeling inside of my body like I was burning; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot unknown: true) via an unspecified route of administration at arm right on 03Feb2021 at a single dose for COVID-19 immunization. The patient was not pregnant. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot unknown: true) at left arm on 13Jan2021 at 04: 45 PM at a single dose for COVID-19 immunization. Other medical history included asthma and known allergies: penicillin. Concomitant medications the patient received within 2 weeks of vaccination included ascorbic acid (VITAMIN C) and multivitamins for women. No other vaccine in four weeks. 2 hours after vaccination the patient started with fever 120 (no units specified) and a lot of discomfort; early morning she had vomit to dehydration point, hot feeling inside of her body like she was burning. She went to urgency room. Treatment received for the adverse event included received electrolytes for dehydration and ondansetron (ZOFRAN, reported as Zofram). The event start date was reported on 03Feb2021 at 01:15 PM. The outcome of all events was resolving. No COVID prior vaccination and no COVID tested post vaccination.
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| 27 | 2021-02-21 | body temperature increased, chills, fever |
Climbing Fever starting around 9:00 pm with current temp of 102.2 as of 10:50 pm (body temperature u...
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Climbing Fever starting around 9:00 pm with current temp of 102.2 as of 10:50 pm (body temperature usually <97). Severe chills onset around 9:30 pm. Mild Soreness at injection site starting approximately two hours after vaccination.
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| 27 | 2021-02-21 | dizziness |
Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old female p...
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Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK4176) intramuscularly in the left upper arm on 13Jan2021 at 14:45 (at the age of 27-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 13Jan2021, the patient was dizzy to the point of needing to lay down. The patient queried whether she should take the second dose. The patient did not receive treatment for this event, nor did the event require a visit to the emergency room or doctor's office. The clinical outcome of "dizzy" was resolved on 24Jan2021.
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| 27 | 2021-02-21 | dizziness |
Pt stated she has POTS syndrome and was feeling dizzy. Pt given 2 bottles of gatorade and monitored ...
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Pt stated she has POTS syndrome and was feeling dizzy. Pt given 2 bottles of gatorade and monitored for additional 15 minutes. Pt tolerated fluids well and stated she felt better and was ready to leave. Walked pt to front door where fiance was meeting her. Pt denied any additional symptoms and stated if her symptom worsened she would go to the emergency room.
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| 27 | 2021-02-21 | lethargy |
Reported generalized pruritus, diffuse rash: face, neck, BUE, torso. Lethargic anxious HR 90, RR 2...
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Reported generalized pruritus, diffuse rash: face, neck, BUE, torso. Lethargic anxious HR 90, RR 20, Administer Epi injector right thigh. Given IM Benadryl. Transported to ER.
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| 27 | 2021-02-22 | fatigue, headache |
After receiving the first dose of the Covid-19 vaccine, I started feeling numbness in my left finger...
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After receiving the first dose of the Covid-19 vaccine, I started feeling numbness in my left fingers within seconds. The injection site with in my left arm. Within 5 minutes, I felt some numbness in my lower lip on the right side. Within a few days, the numbness decreased along with my other, more common symptoms, such as fatigue and headache.
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| 27 | 2021-02-22 | headache |
Patient indicates that after 5 days after administration started feeling headaches, body aches. Test...
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Patient indicates that after 5 days after administration started feeling headaches, body aches. Test results indicate Positive to COVID-19.
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| 27 | 2021-02-22 | fever, headache, chills | fever of 103, chills that lasted hours, nausea and a headache that would not go away. |
| 27 | 2021-02-25 | dehydration |
Nausea and vomiting as well as cramping that lead to being unable to eat for a week. After a week pa...
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Nausea and vomiting as well as cramping that lead to being unable to eat for a week. After a week passed, was admitted to hospital for dehydration and to make sure GI problems were nothing more serious
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| 27 | 2021-02-25 | shortness of breath |
intense upper stomach pains (difficult time bending over, etc); Difficult time breathing/shortness o...
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intense upper stomach pains (difficult time bending over, etc); Difficult time breathing/shortness of breath; This is a spontaneous report from a contactable healthcare professional. This 27-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3247) intramuscularly in the left arm on 25Jan2021 (at the age of 27-years-old) at 09:00 as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medication included escitalopram oxalate (LEXAPRO) from an unknown date for an unknown indication, dicyclomine from an unknown date for an unknown indication, doxycycline from an unknown date for an unknown indication, levothyroxine from an unknown date for an unknown indication, birth control from an unknown date for an unknown indication and women's multivitamins from an unknown date for an unknown indication. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 26Jan2021 at 08:00 the patient experienced intense upper stomach pains (difficult time bending over, etc.). Additionally, she experienced a difficult time breathing/shortness of breath. The patient reported the events resulted in an emergency room or urgent care visit. It was unknown if the patient received treatment for the events. The clinical outcomes of intense upper stomach pains (difficult time bending over, etc.) and a difficult time breathing/shortness of breath were recovering. It was also reported that since the vaccination the patient had tested negative for COVID-19 on 26Jan2021 via nasal swab and polymerase chain reaction tests.
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| 27 | 2021-02-28 | headache, fever, chills |
Sore arm where injected within an hour or so, became more sore over the next day followed by chills,...
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Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; This is a spontaneous report received from a contactable consumer (patient). A 27-year-old female patient (not pregnant) received first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection, Lot number: EL3247), intramuscular on left arm on 27Jan2021, 10:00 AM at single dose for COVID-19 immunization. Relevant medical history included minor allergies to avocados, almonds, and kiwis. Concomitant medications in two weeks included birth control and Vitamin D NOS (vitamin D supplement). No other vaccine was received by the patient within four weeks. On 27Jan2021 at 11:30 AM, the patient experienced sore arm where injected within an hour or so, became more sore over the next day (28Jan2021) followed by chills, body aches, headache and slight fever starting the morning after vaccination on 28Jan2021. No treatment was received by the patient. The patient was not tested COVID prior and post vaccination. On 03Feb2021, the patient stated that on 27Jan2021, the patient received the vaccination and first had the soreness. The patient reported on 29Jan2021 when patient had recovered from symptoms. The outcome of the events was recovered on 29Jan2021. No follow-up attempts are possible. No further information is expected.
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| 27 | 2021-02-28 | chills, headache |
body aches; headache; chills; arm soreness; This is a spontaneous report from a non-contactable cons...
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body aches; headache; chills; arm soreness; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on Jan2021 12:00 PM for covid-19 immunization on the left arm, also at age of 27-year-old. The most recent COVID-19 vaccine facility type was Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced body aches, headache, chills, arm soreness on Feb2021 with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 27 | 2021-03-02 | shortness of breath |
Angioedema; swelling; Difficulty breathing; Tight chest; Facial flushing; Dry eyes and unsettled sto...
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Angioedema; swelling; Difficulty breathing; Tight chest; Facial flushing; Dry eyes and unsettled stomach; Dry eyes and unsettled stomach; This is a spontaneous report from a contactable nurse. A 27-years-old non-pregnant female patient started treceive bnt162b2 (BNT162B2), Lot number: EL9266, intramuscular in left arm on 15Feb2021 at 0900 (at the age of 27 years-old) for COVID-19 immunzation. The vaccination was administered at a workplace clinic. Medical history included Allergy/Sports-Induced Asthma, Lactose Intolerant and food allergies of Kiwi, Lactose Intolerant, Cherry. The patient had a positive COVID-19 test prior to vaccination on 14Nov2020. There was no other vaccinations given within 4 week and concomitant medications within 2 weeks included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), fish oil (FISH OIL). On 15Feb2021 at 10:00, the patient experienced Angioedema/swelling, Difficulty breathing/tight chest, facial flushing, dry eyes and unsettled stomach. Experienced symptoms of flushing 1hour post-vaccination. The clinical course was as follows: She reported that she experienced symptoms of flushing 1hour post-vaccination. About 4 hours later swelling persisted and took Zyrtec to alleviate symptoms, which provided minimal relief. 24 hours post vaccination resulted in ER admission advised per Occupational Medicine at (name). IV SoluMedrol, Bendaryl and Pepcid administered. Overall stay in ER 3 hours. On 17Feb2021, 24 hours post admission rebound symptoms occurring with facial flushing and swelling. Will repeat allergy medication to relieve symptoms PRN. The clinical outcome of the events was recovered with sequalae (as reported by patient: recovered with lasting effects).
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| 27 | 2021-03-02 | dizziness, headache, fever |
Fever; Headache; Lightheaded; This is a spontaneous report from a contactable consumer. A 27-year-ol...
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Fever; Headache; Lightheaded; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 09:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced Fever, Headache, Lightheaded; all on 31Jan2021 at 05:00 AM. No treatment was received for the events.
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| 27 | 2021-03-03 | fever, headache, chills |
101 fever; lymph node swelling in my arm; full body aches and chills; full body aches and chills; he...
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101 fever; lymph node swelling in my arm; full body aches and chills; full body aches and chills; headache; This 27- year-old female patient contactable consumer (reported for herself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 16Feb2021 (at the age of 27-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a Workplace clinic. She has had no other vaccines on the same day or in the past 4 weeks. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2. Medical history and concomitant medications not reported. On 16Feb2021, the patient experienced a 101 fever, lymph node swelling in my arm, full body aches and chills, headache. The patient did not receive treatment for the events. The clinical outcome of the events 101 fever, lymph node swelling in my arm, full body aches and chills, headache was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 27 | 2021-03-08 | fatigue |
Exhaustion/fatigue; This is a spontaneous report from a contactable patient. A 27-year-old female pa...
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Exhaustion/fatigue; This is a spontaneous report from a contactable patient. A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 04Feb2021 at 10:30, at a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number: EL3247) on 14Jan2021 at 10:45 AM, in the right arm, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. The patient showed a negative nasal swab on 21Jan2021. On 04Feb2021, at 19:00, the patient experienced exhaustion/fatigue. The event was considered non-serious. The patient did not receive treatment for the event. Outcome of the event was recovering. The patient has not been tested for COVID-19 since vaccination.
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| 27 | 2021-03-09 | dizziness, fever, chills |
Fever; Chills; dizziness; aches; This is a spontaneous report from a contactable consumer (patient)....
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Fever; Chills; dizziness; aches; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose bnt162b2 (reported as PFIZER COVID 19 VACCINE, lot number: unknown, Lot number wasn't given when receiving shot), via an unspecified route of administration in right arm on 05Feb2021 07:45 AM at single dose for COVID-19 immunisation. The patient did not have other medical history or known allergies. There were no concomitant medications (no other medications in two weeks). The patient was not pregnant. The patient previously received first dose bnt162b2 (reported as PFIZER COVID 19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 07:45 AM at single dose for COVID-19 immunisation. The patient experienced Fever, chills, dizziness, aches on 05Feb2021 07:15 PM. AE resulted in 'None of the above'. The patient did not receive treatment for the events. The patient did not have COVID prior vaccination. The patient had COVID tested post vaccination, type was Nasal Swab and result was negative. The outcome of the event was recovering. Information on the Lot/Batch number has been requested.
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| 27 | 2021-03-09 | chills, fever, headache |
Headache; fever; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer ...
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Headache; fever; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 15:45 at single dose in left arm for COVID-19 immunization. Medical history included allergies to Zithromax. Concomitant medication included topiramate. The patient previously received first dose of BNT162B2 on 13Jan2021 03:45 PM in left arm. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient experienced Headache, fever, chills, nausea, vomiting. Headache began about 2 hours after 2nd dosage administered (03Feb2021 17:45). Rest of symptoms began about 12 hours after headache. Vomiting, fever, chills and nausea all lasted about 8 to 10 hours. Headache lasted about 24 hour. No treatment was received for the events. The outcome of all events was resolved on 04Feb2021. Information about lot/batch has been requested.
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| 27 | 2021-03-09 | dizziness, fatigue, headache, chills, fever |
received first dose on 27Dec2020 and second dose on 13Jan2021; received first dose on 27Dec2020 and ...
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received first dose on 27Dec2020 and second dose on 13Jan2021; received first dose on 27Dec2020 and second dose on 13Jan2021; chills; fever; dizziness; headache; nausea; lack of appetite; fatigue; hot flashes; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, ), intramuscular in the Left arm on 13Jan2021 13:30 PM at single dose for covid-19 immunisation. Patient was not pregnant. Medical history was None. No known allergies. No other medical history. No other vaccine in four weeks. Other medications in two weeks included Birth control. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899, administrator route=Intramuscular, vaccine location=Left arm) on 27Dec2020 at age of 27 years old for COVID-19 immunization and nothing after the first shot. The night of the second shot (13Jan2021) patient had chills, fever, dizziness, headache, nausea, lack of appetite, fatigue, and hot flashes until the following two days (15Jan2021). Then dizziness, fatigue, nausea, lack of appetite, chills, and hot flashes for about a week (in Jan2021). No treatment for the adverse events. No covid prior vaccination. No covid tested post vaccination. The patient administered vaccine in Doctor's office/urgent care. The outcome of 'received first dose on 27dec2020 and second dose on 13jan2021' was unknown, of other events was recovered.
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| 27 | 2021-03-15 | dizziness |
Sore Arm; Nausea; Light Headedness; This is a spontaneous report received from a contactable consume...
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Sore Arm; Nausea; Light Headedness; This is a spontaneous report received from a contactable consumer (patient herself). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number EN5318) via an unspecified route of administration to left arm on 04Feb2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported as patient experienced with Sore Arm, Nausea, Light Headedness on 04Feb2021. Patient did not receive any treatment for events. Outcome of events was recovered on an unspecified date. No follow-up attempts are possible. No further information was provided.
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| 27 | 2021-03-17 | cough, shortness of breath, throat swelling |
Less than 5 minutes after receiving the vaccine, I experienced tingling in my left fingers. Less tha...
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Less than 5 minutes after receiving the vaccine, I experienced tingling in my left fingers. Less than 15 minutes of receiving the Covid-19 Pfizer vaccine, I experienced chest tightness and shortness of breath. I thought I was having an asthma attack, so I proceeded to use my inhaler. After using the inhaler, I started coughing while trying to breathe. Next my tongue started swelling, followed by my throat and back of the tongue. The nurses / EMT reported that my face turned red and my heart-rate was elevated. The EMT proceeded to give me EpiPen, which almost instantly caused the swelling in my tongue to go down. While being monitored for 3 more hours at the emergency room, the swelling went down even more and breathing became more normal. The following day, I visited my allergist doctor, and I was still experiencing some swelling in my neck and chest tightness. I was given a steroid shot, which seemed to clear the rest of the allergic reaction.
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| 27 | 2021-03-18 | chills, fever, dizziness |
Feverish/Temp (Body temperature) 99.2; chilled feeling; Right chest tightness; Dizziness; Ringing in...
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Feverish/Temp (Body temperature) 99.2; chilled feeling; Right chest tightness; Dizziness; Ringing in ears; BP (Blood pressure) 136/88; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269) intramuscularly on 03Feb2021 01:30 PM at single dose in left arm for COVID-19 immunization at School or Student Health Clinic. Medical history included Anxiety/depression. Allergies to medications, food, or other products included Lamictal and Coconut. The patient was not pregnant at time of vaccination. The other medications patient received included birth control within 2 weeks of vaccination. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient was feverish but along with chilled feeling, also experienced right chest tightness, dizziness and ringing in ears on 03Feb2021. Adverse events resulted in Emergency room/department or urgent care. Treatment received for the adverse events was reported as yes, will go to urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient had labs and procedures included Temp (Body temperature) 99.2; BP (Blood pressure) 136/88; HR (Heart rate) 81; RR (Respiratory rate) 15; Oxygen 100% on 03Feb2021. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269) to reported events cannot totally be excluded.
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| 27 | 2021-03-22 | malaise, influenza like illness |
One day after vaccine developed diarrhea with nause and vomiting. She also reported general malaise ...
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One day after vaccine developed diarrhea with nause and vomiting. She also reported general malaise similar to "Influenza like symptoms". She stay at bed and improved from the general malaise symptoms but persisted with nausea and vomiting. On day 3, she reported at night that her pulse Ox dropped to 88% and was taken to ER. She was admiited with suspected atelectasis of left lower lobe abd possible pneumonia which is difficult to evaluate due to her chronic lung condition. She had improved and is no longer having vomiting or general malaise and expected to be discharge home soon.
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| 27 | 2021-04-01 | shortness of breath |
Death 5 hours after second shot. Decedent contacted her mother around 3:30 c/o difficulty breathing....
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Death 5 hours after second shot. Decedent contacted her mother around 3:30 c/o difficulty breathing. Died on 4/1/20
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| 28 | 2020-12-31 | dizziness, fever, chills |
From 0-24 hours post injection, I had soreness at injection site. At 18 hours post injection, I had ...
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From 0-24 hours post injection, I had soreness at injection site. At 18 hours post injection, I had abnormal back pain (lasted about 30 minutes). At 29 hours post injection, I had rapid onset chills (lasted 3 hours) and fever (highest measurable was 100.3, lasted about 1 hour), feeling faint (15 minutes), nausea (15 minutes).
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| 28 | 2020-12-31 | headache, fever, sweating, chills | Sudden onsite 6pm the next day of fever, chills, sweats, headache, body aches |
| 28 | 2020-12-31 | headache |
Vomited suddenly without knowledge of being nauseous; only happened once but nausea remained after. ...
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Vomited suddenly without knowledge of being nauseous; only happened once but nausea remained after. After about an hour and a half muscle aches and headache kicked in.
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| 28 | 2021-01-01 | fever, chills |
31Dec 0300 Extreme body ache, unable to move left arm 31Dec Body aches, chills, swelling of injectio...
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31Dec 0300 Extreme body ache, unable to move left arm 31Dec Body aches, chills, swelling of injection site 31 Dec 1700 fever 102.1, injection site welt hard, painful, hot with 3 inch diameter, severe body aches and chills. Alternating Tylenol and Motrin begins fever lowers to 99 01Jan severe body aches and chills 01Jan 1130 fever of 101.1 while continuing alternating Tylenol and Motrin administration from previous day. 02Jan no fever, mild body aches, minor swelling and tenderness of injection site.
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| 28 | 2021-01-01 | fever |
Fever, muscle pain. Onset around 21 hours after vaccine, resolved around 6 hours later without inte...
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Fever, muscle pain. Onset around 21 hours after vaccine, resolved around 6 hours later without intervention.
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| 28 | 2021-01-01 | fever, chills, headache | Fever, chills, headache, body aches |
| 28 | 2021-01-03 | dizziness |
Hot flash and dizzy next thing she knew she was in a stretcher. Gave her an ice pack and elevated fe...
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Hot flash and dizzy next thing she knew she was in a stretcher. Gave her an ice pack and elevated feet. Went to ED, per patient did not receive any medications, just had an EKG.
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| 28 | 2021-01-03 | headache |
Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain....
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Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain. Started on Thursday 17Dec2020 at 7:45 pm; Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain. Started on Thursday 17Dec2020 at 7:45 pm; This is a spontaneous report from a contactable nurse reported for herself. A 28-year-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in left arm on 16Dec2020 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced left sides shock like pains in head, lasted 3-5 seconds and went away. It's a stabbing shock like pain. The events started on Thursday 17Dec2020 at 19:45. It was unknown whether treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the event left sides shock like pains in head is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 28 | 2021-01-03 | shortness of breath | Patient developed SOB, wheezing, tongue swelling, facial tingling. |
| 28 | 2021-01-03 | fever, fatigue |
She received the vaccine on 12/30/2020 at approximately 4:35 PM. At 7 PM she experienced immediate e...
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She received the vaccine on 12/30/2020 at approximately 4:35 PM. At 7 PM she experienced immediate exhaustion, very hot, and body aches. Her temp when she got home was 102.7. She experienced an all over rash and her temp fluctuated for 65 hours. She went to Urgent Care both on Saturday and Sunday due to the ?burning? of the rash. She received Steroid treatment both days. She is back to work today, however, continues to have burning rash. She was advised by the Urgent Care provider not to receive the second injection, and not to ever receive vaccines with the mRNA component.
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| 28 | 2021-01-03 | chills, headache |
headache, body aches, chills. Took Tylenol and headache improved but came back the next day. Continu...
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headache, body aches, chills. Took Tylenol and headache improved but came back the next day. Continued to take Tylenol PRN with relief.
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| 28 | 2021-01-03 | dizziness |
within 10 minutes patient became pale and lightheaded, heart rate elevated, continued to have flushe...
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within 10 minutes patient became pale and lightheaded, heart rate elevated, continued to have flushed feeling. Rapid response called observed, provided water and ice. Felt dizzy when tried to walk. Observed for 45-60 mins.
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| 28 | 2021-01-04 | throat irritation, runny nose |
About 1 hour after the vaccine, I developed watery eyes, itchy, runny nose, sneezing, itchy throat. ...
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About 1 hour after the vaccine, I developed watery eyes, itchy, runny nose, sneezing, itchy throat. This lasted throughout the day and required 50mg of Benadryl before symptoms finally subsided around 9pm that night.
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| 28 | 2021-01-04 | throat irritation |
About 30-35 mins, after vax, I started noticing my eyes were itching, and I started scratching my fa...
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About 30-35 mins, after vax, I started noticing my eyes were itching, and I started scratching my face. I got in my car and realized it's not going away. I need advice on what to take for it to go away. I noticed a itchy throat. Not sure if it's something that's due to the vaccine.
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| 28 | 2021-01-04 | chills, fatigue, headache |
Around 12 hours post-vaccination with the 2nd dose, noticed severe chills, fatigue, headache, and fu...
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Around 12 hours post-vaccination with the 2nd dose, noticed severe chills, fatigue, headache, and full-body myalgias. Severe chills lasted ~6 hours, then subsided. Severe fatigue continued for ~24 hours (still feeling fatigued, but it is improving). Milder chills continued for ~24 hours but have mostly subsided. Headache and myalgias have improved over the last 24 hours but are still present despite use of ibuprofen 200mg Q6H.
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| 28 | 2021-01-04 | chills, headache |
Body aches; chills; redness and pain in injection site; redness and pain in injection site; headache...
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Body aches; chills; redness and pain in injection site; redness and pain in injection site; headache; This is a spontaneous report from a contactable other hcp (patient). A 28-year-old female patient received bnt162b2 (lot number: EL0140), intramuscularly at arm right, first dose on 27Dec2020 10:15, at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS) and hypertension from an unknown date. The patient was not pregnant. No known drug allergies. Concomitant medication included losartan, and metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced body aches, chills, redness and pain in injection site, headache on 27Dec2020 12:00. Therapeutic measures were taken as a result of body aches, chills, redness and pain in injection site, headache, treatment included Tylenol. The events were reported as non-serious. The outcome of the events was not recovered.
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| 28 | 2021-01-04 | fatigue, body temperature increased, chills | Chills, Body Aches, Temp 99.3, fatigue resolved within 48 hours from onset |
| 28 | 2021-01-04 | chills |
Chills, body aches for hours; Chills, body aches for hours; This is a spontaneous report from a cont...
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Chills, body aches for hours; Chills, body aches for hours; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 26Dec2020 at 18:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. Medical history included depression, chronic pain, obesity. The patient was not pregnant at the time of vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), melatonin, fluticasone propionate (FLONASE), paracetamol (TYLENOL), and ibuprofen; all for unknown indications from unknown dates and unknown if ongoing. The patient previously took cefdinir (OMNICEF) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 27Dec2020 at 5:00, the patient experienced chills and body aches for hours. The patient did not receive treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the chills and body aches for hours was not resolved. Information on the lot/batch number has been requested.
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| 28 | 2021-01-04 | headache, chills, dizziness, fever |
Day of administration around 2100 I started feeling a little off, got a little bit of a headache and...
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Day of administration around 2100 I started feeling a little off, got a little bit of a headache and felt warm. While sleeping I could feel that I had chills and felt very warm. Woke up at about 0200 to take my temperature. Felt dizzy when I got up, still had a headache and a fever of 101.0 (taken orally). Contacted a nurse triage line to ensure I can take t=Tylenol to bring the fever down and get rid of the headache. She said yes, which is when I took 500mg Extra Strength Tylenol rapid release. Continued to feel not so well, and broke my fever around 0630 timeframe. Once I woke up around 0900 (day after administration) still felt a little warm (99.5) and a mild headache. Will keep an eye on any other adverse reactions.
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| 28 | 2021-01-04 | chills, fever | Experienced nausea, fever, chills, and body aches |
| 28 | 2021-01-04 | fatigue, fever, headache |
Fever (99.6); Arm soreness; Headache; Fatigue; This is a spontaneous report from a contactable physi...
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Fever (99.6); Arm soreness; Headache; Fatigue; This is a spontaneous report from a contactable physician (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), intramuscularly in the left arm, on 21Dec2020 at 07:15 (at the age of 28-years-old) at a single dose for COVID-19 immunization. Medical history included migraines and allergies to mango. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included magnesium (MANUFACTURER UNKNOWN) taken as supplement. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever (99.6), arm soreness, headache, and fatigue on 21Dec2020 at 20:00. The events were reported as non-serious. The patient underwent lab tests and procedures, which included body temperature: 99.6 on 21Dec2020. No therapeutic measures were taken as a result of the events. The clinical outcome of fever (99.6), arm soreness, headache, and fatigue was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 28 | 2021-01-04 | chills, fever | Fever 103.9, chills, vomiting |
| 28 | 2021-01-04 | shortness of breath, dizziness |
Nausea; racing heart rate; restlessness; Dizziness; Shaking; breathlessness; This is a spontaneous r...
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Nausea; racing heart rate; restlessness; Dizziness; Shaking; breathlessness; This is a spontaneous report from a contactable consumer reporting for herself. A 28-years-old female patient received bnt162b2 (BNT162B2 ; Lot # EK9231) vaccine , via an unspecified route of administration on 27Dec2020 at single dose for Covid-19 immunisation . Medical history included drug hypersensitivity to amoxicillin sodium on an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced about one minute and a half after receiving the vaccine racing heart rate on 27Dec2020 with outcome of recovered , restlessness on 27Dec2020 with outcome of recovered , dizziness on 27Dec2020 with outcome of recovered , shaking on 27Dec2020 with outcome of recovered , breathlessness on 27Dec2020 with outcome of recovering , nausea on 28Dec2020 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate: racing on 27Dec2020. The patient received diphenhydramine (BENADRYL) to treat dyspnea.
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| 28 | 2021-01-04 | dizziness |
Red hive like rash and felt hot. She was also feeling dizzy Epinephrine given IM After 5 minu...
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Red hive like rash and felt hot. She was also feeling dizzy Epinephrine given IM After 5 minutes, her symptoms returned and another Epinephrine given IM
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| 28 | 2021-01-04 | headache, fever |
fever, aches, headache began 2 hours after vaccination but persisted over 48 hours. Tested for COVI...
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fever, aches, headache began 2 hours after vaccination but persisted over 48 hours. Tested for COVID per employee health policy on 12/31 - negative. Rash began 2 days after vaccination. was seen at Urgent care on 1/2/21, given prednisone. Rash worsened, fever broke. seen again 1/3/21 - given kenalog shot. tested for COVID-19 (negative). Rash continues to spread, headache improved but not resolved.
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| 28 | 2021-01-05 | fatigue, headache, body temperature increased |
Body aches and fatigue about 5 hours after injection. Worsening body aches and head ache around 9pm ...
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Body aches and fatigue about 5 hours after injection. Worsening body aches and head ache around 9pm on same day. 5am on 1/6 severe body aches and temperature of 100.3
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| 28 | 2021-01-05 | chills, fatigue | Chills, body aches, fatigue |
| 28 | 2021-01-05 | fatigue, headache, body temperature increased |
Had 2nd vaccine at 1pm yesterday (01/05). 8pm started to had fatigue, body ache. At 10pm got worse...
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Had 2nd vaccine at 1pm yesterday (01/05). 8pm started to had fatigue, body ache. At 10pm got worse severe headache, fatigue, bodyache, 99-100.6. 10am this morning (01/06). Headache was severe that staff had to take medicine and could not sleep well.
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| 28 | 2021-01-05 | headache, fever | Headache, Myalgia & Fever |
| 28 | 2021-01-05 | discomfort, dizziness, shortness of breath |
I received my vaccine at 1215 on 12/31/20. At 1800 on 12/31/20 I began to feel mild shortness of br...
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I received my vaccine at 1215 on 12/31/20. At 1800 on 12/31/20 I began to feel mild shortness of breath. I then became dizzy at 1805. At 1815 I developed blurred vision. The dizziness and blurred vision prevented me from standing. I was able to walk with assistance at 1915. The blurred vision lasted until 1915. The dizziness lasted until 2230. At 2000 I had muscle aches and joint pain and could not get comfortable. Muscle aches and joint pain lasted until 1-1-21 at 1930. I did not seek medical treatment. (I working in the ER and did not feel it was severe enough to check in because the shortness of breath was mild and went away shortly after the dizziness began at 1815). I took Benadryl 50 mg at 1930 and 1000mg of Tylenol.
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| 28 | 2021-01-05 | dizziness, body temperature increased, headache, chills |
Temp 102.6 while taking tylenol, headache muscle, Hr 140 01/05/21 chills, lightheadedness, 01/06...
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Temp 102.6 while taking tylenol, headache muscle, Hr 140 01/05/21 chills, lightheadedness, 01/06 diarrhea
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| 28 | 2021-01-05 | fatigue, fever |
swollen lymph nodes on neck; pain in the injection site; general body fatigue; low grade fever; mild...
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swollen lymph nodes on neck; pain in the injection site; general body fatigue; low grade fever; mild tummy ache; body aches; This is a spontaneous report from a contactable other health professional (other-HCP) (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot number: EI0142) intramuscularly at left arm on 30Dec2020 at 06:30 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history included known allergies: trees, grass, pollen, certain flowers, indoor allergens (don't know specifics). No other medical history. The patient was not pregnant. Other medications the patient received within 2 weeks of vaccination included loratadine/pseudoephedrine sulfate (CLARITIN D-12), drospirenone/ethinylestradiol betadex clathrate (YAZ) and mometasone furoate (FLONASE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events pain in the injection site, swollen lymph nodes on neck, mild tummy ache, body aches, low grade fever, general body fatigue; all occuring the day after injection, on 31Dec2020 at 06:15 AM. The events were reported as non-serious. Treatment received for events included tylenol took on 31Dec2020 at 8:40 PM. The outcome of event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 28 | 2021-01-06 | body temperature increased, somnolence, fatigue, shortness of breath |
After receiving vaccine, woke up around 3 am experiencing nausea, loss of vision x 1-2 minutes, sync...
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After receiving vaccine, woke up around 3 am experiencing nausea, loss of vision x 1-2 minutes, syncope, difficulty breathing, numbness & tingling in hands and feet. Measured temperature of 102 F. Slept most of the next day and missed work x 1 day. The following day was improved but still with moderate fatigue and nausea. Took ibuprofen with some improvement.
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| 28 | 2021-01-06 | chills, headache, fever |
Arm soreness, fever (101.5F), chills, rigors, headache, and body aches. The fever and chills were re...
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Arm soreness, fever (101.5F), chills, rigors, headache, and body aches. The fever and chills were refractory to ibuprofen and required both ibuprofen and Tylenol to break. The fever and chills continued for 24 hours and the headache/body aches continued for 36 hours, the arm soreness has improved but is ongoing.
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| 28 | 2021-01-06 | fatigue |
Estimated due date: 03/05/2021 All I had really was exhaustion and I had to go lay down. I probably ...
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Estimated due date: 03/05/2021 All I had really was exhaustion and I had to go lay down. I probably took an hour nap and it felt better. I still felt sluggish but a little better. There is no way I could have worked that day the way I was feeling.
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| 28 | 2021-01-06 | fever, headache |
Patient received the covid vaccine on 1/26/2021 Two hrs post injection c/o pain/soreness at site. F...
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Patient received the covid vaccine on 1/26/2021 Two hrs post injection c/o pain/soreness at site. Four hrs post injection c/o general body ache, slight headache, fever 99.7. Denies any respiratory, ocular, or GI symptoms. Note - injection lot # not available.
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| 28 | 2021-01-06 | shortness of breath, dizziness, headache |
Pt c/o shortness of breath 2.5 hours after vaccine. Also reports hives, headache, dizziness and naus...
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Pt c/o shortness of breath 2.5 hours after vaccine. Also reports hives, headache, dizziness and nausea since last night.
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| 28 | 2021-01-06 | dizziness, shortness of breath |
Pt reported difficulty breathing, tightness in her throat and felt very dizzy. She was noted to be ...
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Pt reported difficulty breathing, tightness in her throat and felt very dizzy. She was noted to be red faced along with redness in her throat and chest. Pt given Benadryl 25 mg liquid po at 0925 am and coaching for slowed breathing and symptoms recovery. She reported feeling better gradually and with in 15 minutes pt felt much better she declined ER transport
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| 28 | 2021-01-06 | chills, fever |
had a 102 degree fever for about 15 hours which started the evening of 1/5/21, which also included c...
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had a 102 degree fever for about 15 hours which started the evening of 1/5/21, which also included chills and muscle aches. The muscle aches lasted about 24 hours. The injection site was my left arm and I now have swelling in my left axilla which started the evening of 1/6/21 and is still currently swollen. I am an ultrasound technologist and was able to scan myself this morning when I came back to work. It appears I have a cluster of reactive lymph nodes in the area of swelling within my left axilla, the largest measuring 3.0 cm. It is very tender in the area of swelling and the pain radiates down my left arm. I had a lot of pain at the injection site that lasted for about 24 hours, it is now subsiding. However, for the last 24 hours it has been very painful to bend my arm. Any time I tried to bend my arm it sent a throbbing pain down to my left hand, it is still occurring today.
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| 28 | 2021-01-07 | fever |
2 hours after receiving the vaccine, patient noticed blochiness on chest and fever. Last 2 hours a...
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2 hours after receiving the vaccine, patient noticed blochiness on chest and fever. Last 2 hours and the went away.
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| 28 | 2021-01-07 | chills, fever |
About 12 hours after the shot, I had significant chills, body aches, fever, severe nausea that induc...
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About 12 hours after the shot, I had significant chills, body aches, fever, severe nausea that induced vomiting (unable to keep down water). 12 hours then after these symptoms is when things began to slowly subside. Just ended up missing work for two days.
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| 28 | 2021-01-07 | fever, chills | Chills and 99.7° fever 26 hours after injection. Very painful arm. |
| 28 | 2021-01-07 | chills, fatigue, fever |
Chills; subjective fevers less than 100; fatigue; soreness at injection site; This is a spontaneous ...
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Chills; subjective fevers less than 100; fatigue; soreness at injection site; This is a spontaneous report from a contactable physician (the patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 16Dec2020 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Dec2020, the patient experienced chills, subjective fevers less than 100, fatigue, and soreness at injection site 24 hours. The clinical outcome of chills, subjective fevers less than 100, fatigue, was recovered on an unspecified date. The clinical outcome of soreness at injection site 24 hours was recovered on 17Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 28 | 2021-01-07 | somnolence, dizziness |
Dizziness for hours; vomiting; sleepiness; This is a spontaneous report from a contactable healthcar...
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Dizziness for hours; vomiting; sleepiness; This is a spontaneous report from a contactable healthcare professional. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm on 30Dec2020 16:00 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient known allergies: amoxicillin. The patient experienced dizziness for hours, vomiting, sleepiness on 31Dec2020 22:00. The patient received no treatment. The outcome of the events was recovering. Information on the lot number has been requested.
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| 28 | 2021-01-07 | dizziness |
Entered observation as a "30 minute" Observant, r/t her past vaccine (Pfizer first dose). States sh...
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Entered observation as a "30 minute" Observant, r/t her past vaccine (Pfizer first dose). States she was dizzy for about 4hrs after 1st vaccination. Onset 45mins, after 1st vaccination. Became dizzy around (1710) while in observation. This nurse and staff assisted pt to bed to lay down in vaccination clinic. Denies SOB, chest pain, or trouble breathing when asked. Currently remains laying down on bed @ present time (1720). Cold compress applied to help alleviate s/s of dizziness. Still voices s/s of dizziness @ 1730. This nurse asked pt if she would like to be sent to ER. Pt voiced she was "ok", and did not want to be sent to ER. Pt called family @ 1730, r/t having a ride home. This nurse insisted to pt that she did not need to drive "herself". Pt, left w/ family @ 1750, voices slight dizziness upon leaving. Transported via w/c by this nurse w/ family. Left observation @ 1750.
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| 28 | 2021-01-07 | chills, fever | Fever Chills Body ache |
| 28 | 2021-01-07 | fever, headache | Fever and headache |
| 28 | 2021-01-07 | fever, chills, headache |
Fever the morning after; sore arm; headache; chills; body aches; developed a rash around injection s...
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Fever the morning after; sore arm; headache; chills; body aches; developed a rash around injection site, chest, neck, and face; developed a rash around injection site, chest, neck, and face; This is a spontaneous report from a contactable other HCP (patient). A 28-years-old female patient (pregnant: No) received first dose bnt162b2 (BNT162B2 lot number: EH9899), intramuscular on Left arm on 30Dec2020 12:00 at single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, Sulfa, Other-medical-history: Allergy induced asthma. No other-vaccine-in-four weeks. No other-medications-in-two weeks. Since 30Dec2020 13:00 Started with sore arm and headache shortly after injection. Since 30Dec2020 6-8 hours later chills and body aches started. At some point in the same time range, developed a rash around injection site, chest, neck, and face. Fever the morning after on 31Dec2020. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment received for AE included Steroid and Benadryl Injection. The event outcome was recovering. No-covid-tested-post-vaccination. The events were non-serious.
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| 28 | 2021-01-07 | fever, headache, chills, fatigue |
First experienced arm pain at site of injection, chills and body aches within 13 hours of the 2nd CO...
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First experienced arm pain at site of injection, chills and body aches within 13 hours of the 2nd COVID-19 Pfizer vaccine. 27 hours following administration of the vaccine in addition to body aches and chills, I then experienced headaches, fever of 101.8, and fatigue.
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| 28 | 2021-01-07 | cold sweat, headache, fatigue, fever |
Headache, Myalgia, Fever, fatigue, feels hot but temp is normal. Narrative: 12/28 onset of "feeling...
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Headache, Myalgia, Fever, fatigue, feels hot but temp is normal. Narrative: 12/28 onset of "feeling crummy" - fatigue and "really bad" headache. She went home after work and went to sleep. 12/29 onset of feeling "hot" but her temperature is normal. Body aches, slight headache, and feeling "clammy". She took ibuprofen on 12/29 and is currently at work. Employee reports she usually feels mildly ill the day after a flu vaccine but this adverse reaction is much worse than that. 12/30 - employee reports she developed diarrhea and a temp to 99. Continues to have body aches and mild headache. 12/31 all symptoms resolved.
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| 28 | 2021-01-07 | fatigue, chills |
Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fati...
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Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; This is a spontaneous report from a contactable other hcp reporting for herself. This 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) the first dose on 15Dec2020 14:00 (Lot # EK5730) in the left arm and the second dose on 04Jan2021 12:45 (Lot # EL1284) in the right arm, both via an unspecified route of administration at single dose for Covid-19 immunisation. Medical history included asthma and allergies to Penicillin and Oxycodone. Concomitant medication included omalizumab (XOLAIR), salbutamol sulfate (PROAIR [SALBUTAMOL SULFATE]), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). On 04Jan2021 23:00, the patient experienced injection site soreness, fatigue/chills (day). Bad diarrhea at night. No treatment was performed. The outcome of the events was recovered. The patient underwent lab tests and procedures which included Nasal Swab, Covid test on 28Dec2020 was negative. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination.
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| 28 | 2021-01-07 | headache |
Patient complained of chest tighness about 20 minutes after vaccine. Benadryl 25mg given, BP 220/12...
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Patient complained of chest tighness about 20 minutes after vaccine. Benadryl 25mg given, BP 220/120. Pepcid 40mg po, Xyzal 5mg po, and tylenol 975 po given for headache. Patient given Toradol 30mg IM for continued complaints of chest tightness. patient monitored for 3 hours.
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| 28 | 2021-01-07 | fatigue |
Post-viral rash on day 10-13 after vaccine administration; Extreme fatigue; This is a spontaneous re...
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Post-viral rash on day 10-13 after vaccine administration; Extreme fatigue; This is a spontaneous report from a contactable pharmacist (patient). A 28-year-old female patient received BNT162B2 (lot number and expiry date not reported), via an unspecified route of administration on the left arm on 17Dec2020 at 16:00 at single dose for COVID-19 immunization. Medical history included migraine, PCOS from an unknown date and unknown if ongoing and known allergy to kiwi. Concomitant medication included naproxen and methocarbamol (ROBAXIN). The patient experienced extreme fatigue and post-viral rash on day 10-13 after vaccine administration on 27Dec2020. Therapeutic measures were taken as a result of post-viral rash which included treatment with Benadryl (in case of allergic reaction). The patient did not recover from the events. Information about Lot/Batch has been requested.
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| 28 | 2021-01-07 | headache |
Some nausea; Got a pulsating headache; Shortly after receiving the vaccine I felt a flushed feeling ...
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Some nausea; Got a pulsating headache; Shortly after receiving the vaccine I felt a flushed feeling in my cheeks.; My left arm also was extremely hard, sore, and tender/swollen.; My left arm also was extremely hard, sore, and tender/swollen.; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscular on 22Dec2020 16:00 at single dose at arm (for confirmation) for COVID-19 immunization. Medical history included anxiety. The patient's concomitant medications were not reported. On 22Dec2020 17:00, Shortly after receiving the vaccine the patient felt a flushed feeling in her cheeks. The patient's left arm also was extremely hard, sore, and tender/swollen. About an hour afterwards, 18:00 I got a pulsating headache that lasted for 3 days. It was only mildly relieved with Tylenol and ibuprofen. It felt similar to a migraine and accompanied with some nausea on 23Dec2020 day 2. The patient received treatment for the events. The outcome of the events was recovered on an unspecified date in Dec2020.
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| 28 | 2021-01-07 | sweating, weakness, headache |
Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; ...
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Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; This is a spontaneous report from a contactable nurse. A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number= ELO140, via an unspecified route of administration, in the right arm, on 31Dec2020 at 13:45 (at the age of 28 years-old) as a single dose for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included polycystic ovarian syndrome. There were no concomitant medications. The patient had not received other vaccines in 4 weeks nor taken any other medications in 2 weeks. Prior to the vaccination the patient was not diagnosed with COVID-19. On 01Jan2021 at 0700 the patient experienced hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The clinical course was as follows: Sudden development of hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The vision blurring and hot flashes resolved within 15-20 minutes but the fatigue, headache and nausea persisted throughout the day. The patient was not hospitalized for the event nor was treatment administered. The clinical outcome of the hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. Since the vaccination, the patient has not been tested for COVID-19.
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| 28 | 2021-01-07 | chills, fever |
The day after my first vaccine, I felt overall achy and chills, this only lasted approx 6 hrs then I...
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The day after my first vaccine, I felt overall achy and chills, this only lasted approx 6 hrs then I went to bed. The day after my second vaccine, the entire day I felt extreme arm pain, full body aches, chills and had a fever. It was hot in my room and I was wearing multiple layers of clothing and laying under my blankets, shivering. It was very uncomfortable and lasted much longer but I had heard the second vaccine was a bit more intense so I figured this was to be expected. The following morning I woke up feeling like brand new.
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| 28 | 2021-01-07 | chills, fever |
chills; low grade fever; This is a spontaneous report from a contactable nurse (patient). A 28-year-...
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chills; low grade fever; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the right arm on 31Dec2020 11:45 at a single dose for COVID-19 immunization. The patient's medical history included allergies to dairy and infection. Concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) on 10Dec2020 for immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 01Jan2021 06:00, the patient woke up with chills and low grade fever. These were same symptoms as when she had the actual infection. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious by the reporter. The following information on the batch number has been requested.
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| 28 | 2021-01-08 | cough, chills, headache, fatigue, fever, dizziness |
Approximately 4 hours after the vaccine administration, I started getting symptoms that started mild...
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Approximately 4 hours after the vaccine administration, I started getting symptoms that started mild and became severe including: headache, dry cough with chest pressure, dizziness/lightheaded, joint pain, body aches, fatigue, and chills. At 5:30 pm I started getting a fever, that started at 100.5 then increased to 103.3 by 8:30 pm. I was also nauseous and vomited once. I was tested the next morning for influenza and COVID and was negative. My fever came back down to 98.8 around 12 pm the next day. Overall, symptoms lasted approximately 30 hours after the vaccine was administered. I was out of work the following day after the vaccine. Now, 2 days after the vaccine I am just mildly fatigued with a dry cough left.
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| 28 | 2021-01-08 | fatigue, headache |
Arm soreness starting the next day after injection and lasting for 4 days Fatigue starting about 6 h...
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Arm soreness starting the next day after injection and lasting for 4 days Fatigue starting about 6 hours after injection and lasting for 2 days Brain fog starting about 6 hours after injection and lasting for 2 days Mild headache starting about 6 hours after injection and lasting for about 4 days
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| 28 | 2021-01-08 | dizziness |
Dizzy, lightheaded, vertigo, nausea, vision out of focus, unable to walk straight and have to stabil...
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Dizzy, lightheaded, vertigo, nausea, vision out of focus, unable to walk straight and have to stabilize myself on the wall. I have had 6 episodes lasting 3-24 hours. It has been over 2 weeks (since 12/26/2020 - now).
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| 28 | 2021-01-08 | chills, headache, fever | Fever (100.7 F), chills, headache, muscle pain |
| 28 | 2021-01-08 | fatigue, headache, chills | Joint aching. Muscle aching. 7/10 headache behind eyes. Chills. Fatigue. |
| 28 | 2021-01-08 | chills, fatigue, fever | Myalgia Fatigue for 48 hours; Subjective fever and chills; feeling of fogginess Narrative: |
| 28 | 2021-01-08 | fever, headache |
Soreness in the site of injection on the day of vaccination. Muscle aches, headache and fever began ...
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Soreness in the site of injection on the day of vaccination. Muscle aches, headache and fever began 12 hours after injection. Fever spiked up to 104.1F 16 hours after vaccination. Took Tylenol at hour 16 to help bring fever down. Temperature now 100F and it has been 18 hours since vaccination.
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| 28 | 2021-01-08 | fever, headache, chills | myalgia, chills, headache, and fever |
| 28 | 2021-01-09 | chills, body temperature increased, fatigue, sweating |
- Mild arm muscle pain about 5 min after the vaccine (second dose). - 6-30 hours - progressive myal...
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- Mild arm muscle pain about 5 min after the vaccine (second dose). - 6-30 hours - progressive myalgias and arthralgias, fatigue - 24 hours max temp 99.9, chills, sweats - Symptoms all resolved by 36 hours after vaccine
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| 28 | 2021-01-09 | fever, fatigue, chills |
1/8/21 at 0830 sore arm 1/9/21 at 0200 chills 0800 fever, muscle aches, fatigue 1/10/21 at 1000 Feve...
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1/8/21 at 0830 sore arm 1/9/21 at 0200 chills 0800 fever, muscle aches, fatigue 1/10/21 at 1000 Fever resolved. Fatigue and muscle aches still noted
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| 28 | 2021-01-09 | cough, body temperature increased, headache |
12/18 VACCINATION 12/23 CAME HOME AT 7:30 AM FROM WORK. MY BODY WAS HURTING, SORE. SLEPT. WOKE UP 9-...
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12/18 VACCINATION 12/23 CAME HOME AT 7:30 AM FROM WORK. MY BODY WAS HURTING, SORE. SLEPT. WOKE UP 9-10; VOMITING BODY ACHES, HA. WENT TO ER. COULDN'T KEEP ANYTHING DOWN, EVEN MEDICINE. GAVE ZOFRAN, COVID TEST (NEGATIVE) FELT LIKE I WAS KNOCKED OUT. DIDN'T GET OUT OF BED FOR DAY. TEMP GOT UP TO 102. WITH TYLENOL, IBUPROFREN. BODY WAS SORE. THESE SYMPTOMS ARE STILL PRESENT. LINGERING COUGH. 1/1/2021 FEVERS. LASTED 1-2 DAYS. MUNICEX FOR COUGH AS NEEDED. NOT 100% BETTER, MAYBE 95%
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| 28 | 2021-01-09 | fatigue, fever, headache | Fatigue, body aches, headache, low grade fever, arm pain, axillary pain |
| 28 | 2021-01-09 | malaise, chills, headache |
I am early pregnancy- I haven't even had an ultrasound yet to calculate an exact due date. I am appr...
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I am early pregnancy- I haven't even had an ultrasound yet to calculate an exact due date. I am approximately 6 weeks. About 12 hours after receiving the vaccine I became ill with body aches, chills, nausea, vomiting, general malaise and headache. I was sick until approximately 1530 on 1/10.
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| 28 | 2021-01-09 | body temperature increased, headache, chills, fatigue |
Mild headache about 6 hours after then by about 12 hours after dose had profound chills, body aches,...
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Mild headache about 6 hours after then by about 12 hours after dose had profound chills, body aches, severe nausea and temperature 99.8 F. I treated the nausea with Zofran with some improvement in nausea, but other symptoms continued. My max temperature (without antipyretic affecting) was 100.7 F with continued nausea, body aches, fatigue and headache until the 24 hour after vaccine time frame. After 24 hours, nausea had improved largely to just mild, mild headache continued and fatigue/body aches. Around 28 hours, temp was 100.2 F (outside of last antipyretic dose) with same symptoms. Now around 30 hours out with recent Motrin taken, my nausea is still mild, low appetite, improved body aches and less fatigue. I have not had any site reactions other than pain starting around 6 hours after injection. Course to come yet unknown.
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| 28 | 2021-01-09 | weakness, fever, chills |
Soreness in left arm by injection site 6-24 hours after shot Chills, fever, weakness 12-30 hours aft...
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Soreness in left arm by injection site 6-24 hours after shot Chills, fever, weakness 12-30 hours after shot
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| 28 | 2021-01-10 | headache, fatigue, fever, chills |
About 2 hours after vaccine, experienced soreness down entire left arm. Later that evening low grad...
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About 2 hours after vaccine, experienced soreness down entire left arm. Later that evening low grade fever of 99.9, chills, headache, nausea and fatigue that persisted until Friday evening. Saturday I experienced a headache and nausea, loss of appetite and whole body fatigue and soreness in back, neck and arm. Headache, fatigue, loss of appetite and nausea persists till now (Monday/Day 4)
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| 28 | 2021-01-10 | chills, fever |
At about 11pm the night of vaccine (1/6/2021) my arm began to feel sore at injection site. Then 5 am...
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At about 11pm the night of vaccine (1/6/2021) my arm began to feel sore at injection site. Then 5 am (1/7/2021) my head began to hurt. I then had a fever of 100.7 beginning at 6:45 am (1/7/2021). Throughout the day I had chills and my temp fluctuated between 99.6 and 100.4.
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| 28 | 2021-01-10 | fatigue, chills | Body aches, Chills, fatigue. |
| 28 | 2021-01-10 | headache, fatigue, malaise |
Both at time of first vaccine (12/19) and second vaccine (1/5) I had the same symptoms: headache, mu...
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Both at time of first vaccine (12/19) and second vaccine (1/5) I had the same symptoms: headache, muscle and joint aches, malaise, fatigue, and pain at injection site
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| 28 | 2021-01-10 | throat pain, chills, headache, respiratory tract congestion | Chills, headache, muscle aches, congestion, sore throat |
| 28 | 2021-01-10 | headache, fever, chills, fatigue |
Fever (tmax 100.9), headache, and fatigue with body aches and chills that began the day after receiv...
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Fever (tmax 100.9), headache, and fatigue with body aches and chills that began the day after receiving the vaccine. 7x8cm area of erythema, warmth and induration at injection site.
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| 28 | 2021-01-10 | fatigue, headache, chills, fever |
Fever, chills, headache, myalgias started around 10 pm worsened through the night. Fatigue the next ...
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Fever, chills, headache, myalgias started around 10 pm worsened through the night. Fatigue the next day and nausea. Headache has persisted still have it currently. Have been hydrating and taking ibuprofen which helps
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| 28 | 2021-01-10 | chills, sweating, throat pain |
I woke up with chills and diarrhea . I started to sweat out of no where but I didn't have a fever, t...
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I woke up with chills and diarrhea . I started to sweat out of no where but I didn't have a fever, towards the end of the night I lost my taste for the next two days. I still had chills and was sweaty, I believe the second day I had a sore throat. My boss sent me to get a Covid test and that came back negative.
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| 28 | 2021-01-10 | fatigue, fever, chills, sweating |
Immediate arm soreness after injection but otherwise felt fine until about 2130 when over about a 30...
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Immediate arm soreness after injection but otherwise felt fine until about 2130 when over about a 30 minute period onset of fever, myalgias, chills, and nausea. Called off work from my job as a flight nurse at midnight. Tried to sleep it off until about 0430 when the body aches became unbearable. Ate a few bites of yogurt and took 400mg of ibuprofen. No change in symptoms until 0530 when I took a hot shower which helped relieve some muscle pain. Took 400mg ibuprofen again at 1030 with a small snack with no change in pain or fevers. Took hot shower again which helped briefly. Nausea subsided around 1630, enough that I had a small meal of bland food and another 400mg of ibuprofen. By 1700 more tolerable myalgias and fever came down some. 2230 another 400mg dose of ibuprofen, fitful night of sleep waking again at 4am with shooting lower back pain and fever. Took another dose of 400mg ibuprofen and a hot shower. Woke up at 1000am sweaty with mild myalgias and low grade fever. Took another dose of ibuprofen 400mg, 30 minutes later profusely sweaty but afebrile. Fatigued all day and poor appetite until late evening. Woke up next day after better night of sleep at 0730. Mild fatigue and bad heartburn all day and night. Left arm still sore to touch. This morning (1/11) feeling mild heartburn but better.
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| 28 | 2021-01-10 | malaise, headache, chills | Nausea, headache, chills, overall unwell feeling |
| 28 | 2021-01-10 | fatigue, headache |
On 1/8/21 (day of injection): Severe bodyaches, fatigue, headache, and mild lymph node tenderness th...
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On 1/8/21 (day of injection): Severe bodyaches, fatigue, headache, and mild lymph node tenderness that started 10 hours after the second vaccine dose (booster dose 21 days post initial vaccine administration. ) On 1/11/21: Mild bodyaches, fatigue, headache, and worsening lymph node renderness and visible swelling.
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| 28 | 2021-01-10 | cough, fatigue, headache, fever | Pain at injection site. Fever, body aches, joint aches, headache, fatigue, cough, chest pain. |
| 28 | 2021-01-10 | throat irritation, dizziness | Scratchy throat, dizziness and eventually feeling like her throat is closing in |
| 28 | 2021-01-10 | weakness, chills, headache, fever | fever, chills, headache, extreme body aches, nausea, weakness. |
| 28 | 2021-01-10 | fever | fever. called in sick to work. |
| 28 | 2021-01-10 | headache, chills |
myalgias; Headache; nausea; chills; This is a spontaneous report from a non-contactable healthcare p...
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myalgias; Headache; nausea; chills; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, intramuscularly on 17Dec2020 at 10:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) from an unspecified date, for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Dec2020 at 16:30, the patient experienced headache, nausea, chills, myalgias. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the headache, nausea, chills, myalgias was resolved on an unspecified date in 2020. No follow-up attempts are possible. No further information is expected.
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| 28 | 2021-01-11 | sweating, fatigue, body temperature increased, chills |
12 hours from injection fatigue started. 14 hours past and chills and sweats started (highest measur...
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12 hours from injection fatigue started. 14 hours past and chills and sweats started (highest measured temp 99.4F orally). Body aches occurred at 16 hours. Body aches and sweats and chills continued until hour 36. At hour 33 awoke from sleep with nausea but did not have emesis. At 48 hours all symptoms basically resolved.
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| 28 | 2021-01-11 | chills, fever | Chills Body aches Fever (maximum 101.1 degrees F) |
| 28 | 2021-01-11 | fever | Fever 100.0 F, body aches, |
| 28 | 2021-01-11 | chills, fever |
Fever with temperature of 102.4F; Chills; Body aches; sore joints; Vomiting; The patient received th...
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Fever with temperature of 102.4F; Chills; Body aches; sore joints; Vomiting; The patient received the second dose 19 days from the first dose; This is a spontaneous report from a contactable nurse (patient). A 28-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as Covid 19 vaccine), first dose intramuscular right arm on 17Dec2020 17:30 [05:30 PM](Ej1685; expiration date: unknown) at a single dose and second dose intramuscular right arm on 05Jan2021 17:30 [05:30 PM] (lot number: EK9231; expiration date: unknown) at a single dose for covid-19 vaccination. The patient's medical history was not reported. Concomitant medication included birth control medication. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination. The patient experienced fever with temperature of 102.4F, chills, body aches, sore joints and vomiting on 06Jan2021 01:00. The patient received the second dose on 05Jan2021 17:30 which was 19 days from the first dose. The patient did not received treatment for the adverse event. The patient has not tested for COVID-19 since the vaccination. The reporter assessed the events as non-serious. The outcome of the events was not recovered.
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| 28 | 2021-01-11 | throat pain, fatigue, headache, influenza like illness, malaise, nasal congestion, nasopharyngitis |
Flu-like symptoms; Cold symptoms; tested positive for SARS-COV-2 infection; tested positive for SARS...
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Flu-like symptoms; Cold symptoms; tested positive for SARS-COV-2 infection; tested positive for SARS-COV-2 infection; muscle and body aches; muscle and body aches; loss sense of taste; Congestion nasal; Sore throat; Loss of smell; Sinus pressure; Headache; general fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EJ1685, via an unspecified route of administration on 17Dec2020 16:00 at single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient got the COVID Vaccine and the day after, was exposed to the virus, got sick right away and tested positive for the virus. The patient stated that she got vaccinated around 4pm, 17Dec2020. She was exposed to the virus by the same coworker twice on 18Dec2020 and then the next week, she believed, on 22Dec2020, the coworker tested positive for COVID. Patient stated that her symptoms started 24Dec2020. She did not think she had a fever as she did not feel feverish. She had flu like symptoms from an unspecified date with muscle and body aches from 25Dec2020. She lost her sense of taste and smell from 25Dec2020. She had cold-like symptoms from an unspecified date with congestion nasal and sore throat from 25Dec2020, sinus pressure and headaches from 24Dec2020. She had general fatigue from 24Dec2020 for a while. Patient had not had another COVID test since the one she had 28Dec2020, when she tested positive for COVID. She became symptoms-free on 03Jan2021. Patient was asking should she still get the 2nd dose of the COVID Vaccine. She was also concerned about the reaction her body was going to have to the vaccine after being sick. The patient had recovered from Flu-like symptoms and Cold symptoms on an unspecified date, recovered from muscle and body aches on 29Dec2020, recovered from loss sense of taste and loss of smell on 31Dec2020, recovered from congestion nasal, sinus pressure and headache on 03Jan2021, recovered from Sore throat on 01Jan2021, recovered from general fatigue on 02Jan2021. And outcome of "tested positive for COVID after receiving the COVID Vaccine" was unknown.
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| 28 | 2021-01-11 | fatigue, chills, headache |
Muscle fatigue; Chills; Headache; Fatigue; This is a spontaneous report from a non-contactable other...
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Muscle fatigue; Chills; Headache; Fatigue; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on an unspecified date at a single dose then intramuscularly (left arm) on 05Jan2021 18:30 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. There was no relevant medical history. The patient had no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Jan2021 19:00, the patient experienced Muscle fatigue, chills, headache and fatigue. No treatment was provided in response to the events. The patient assessed the events as non-serious. The patient underwent COVID test post vaccination via nasal swab (PCR) on 21Dec2020 and was negative. The outcome of the events was recovering. No follow-up attempts are possible, information about lot/batch cannot be obtained.
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| 28 | 2021-01-11 | fatigue, influenza like illness |
Nausea; Swollen lymph nodes; tired all day; did not feel like herself-like she had the flu; soreness...
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Nausea; Swollen lymph nodes; tired all day; did not feel like herself-like she had the flu; soreness; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246), intramuscular in the right arm on 02Jan2021 at 11:45 as a single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome, prehypertension, prediabetic, and vitamin D deficiency. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN), erythromycin (MANUFACTURER UNKNOWN), and ciprofloxacin (CIPRO); all for unspecified indications from unknown dates to unknown dates and experienced drug allergy. On 02Jan2021 at 18:00, the patient started having soreness. On 03Jan2021 at 16:45, the patient had nausea. On 03Jan2021, she also had swollen lymph nodes, was tired all day, and "she just did not feel like herself-like she had the flu". The patient was not given any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the soreness, nausea, swollen lymph nodes, tiredness, and "she did not feel like herself-like she had the flu" were recovering.
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| 28 | 2021-01-11 | weakness, dizziness | Patient became pale, felt weak, dizzy. Vital signs stable, 100% O2 on Room air |
| 28 | 2021-01-11 | sweating, headache, fever, chills |
Received 2nd dose of vaccine at 11:00am. Symptoms started at 9pm: severe body aches, chills, headac...
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Received 2nd dose of vaccine at 11:00am. Symptoms started at 9pm: severe body aches, chills, headache, low grade fever of 99.7F. I took motrin and went to bed. Woke up multiple times with chills and sweating. When I woke up: worsened headache and fever of 100F. Will take tylenol and get more rest. Had to call out of work for my midnight shift tonight.
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| 28 | 2021-01-11 | headache, fever | Swelling red itchy injection site, fever, back pain, nausea/vomiting, headache |
| 28 | 2021-01-11 | throat pain | Viral URI; sore throat |
| 28 | 2021-01-11 | headache |
after receiving vaccine ee c/o nausea and headache. B/p 157/84 HR 95 02 sat 98% DD EE left clinic s...
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after receiving vaccine ee c/o nausea and headache. B/p 157/84 HR 95 02 sat 98% DD EE left clinic stating she would follow up with her PCP nausea resolved continue to have h/a 4/10 scale unchanged. b/p 146/73 HR 82 and 02 sat 96% EE refused RRT or ED evaluation
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| 28 | 2021-01-12 | cough, fever | Body Aches, Fever, Cough |
| 28 | 2021-01-12 | fever, chills, fatigue |
Fever - began around 0500 the day after my second injection Severe fatigue - began 2 hours after my ...
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Fever - began around 0500 the day after my second injection Severe fatigue - began 2 hours after my injection Muscle aches - began around 0500 Rigors - began around 1200 Treated with ibuprofen and sleep Symptoms resolved by the morning of 1/13 at 0700
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| 28 | 2021-01-12 | fever, chills, headache |
Fever as high as 101.5F and chills starting since 1am, lasting until 10pm. Extreme body and muscle ...
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Fever as high as 101.5F and chills starting since 1am, lasting until 10pm. Extreme body and muscle aches. headache that was not alleviated with tylenol or advil.
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| 28 | 2021-01-12 | fatigue, headache | Headache, fatigued, red and swelling of infection site, rash and itching at injection site. |
| 28 | 2021-01-12 | headache, chills |
Headache, nausea, body aches, chills, temperature 99F starting around 6pm on the day of vaccination ...
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Headache, nausea, body aches, chills, temperature 99F starting around 6pm on the day of vaccination (I received the vaccine at 7:30am). This lasted all night and was resolved by 1pm the following day.
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| 28 | 2021-01-12 | headache |
Headache; Unexplainable crying/emotional; Unexplainable crying/emotional; Awful R shoulder pain; Thi...
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Headache; Unexplainable crying/emotional; Unexplainable crying/emotional; Awful R shoulder pain; This is a spontaneous report from a contactable other HCP (patient). A 28-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231), via an unspecified route of administration on 05Jan2021 at 12:45 at single dose in right arm for covid-19 immunization. Medical history included acute lymphoblastic leukemia at age 11, remission for 14 years. The patient's concomitant medications were not reported. The patient previously took sulfamethoxazole trimethoprim (BACTRIM) and experienced allergies. The patient experienced headache, unexplainable crying/emotional, awful right shoulder pain; all on 05Jan2021 at 15:30. All events were reported as non-serious. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021.
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| 28 | 2021-01-12 | headache, chills, body temperature increased, fatigue |
I received the first dose of the Pfizer vaccine on December 23 with no complications. The second dos...
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I received the first dose of the Pfizer vaccine on December 23 with no complications. The second dose of Pfizer was administered to me on January 11 and I felt okay at first. At 1 am on January 12 I developed severe chills and muscle aches. The chills, body aches, and fatigue persisted all day. Temperature max was 100.3 orally. I continued to take Tylenol every 6 hours and stayed in bed. The next day I felt slightly better, however, still had a headache. I made an appointment with my primary care doctor.
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| 28 | 2021-01-12 | chills, weakness, body temperature increased |
My arm became tender, I got chills at 330am on 1/12, my temp never got above 99.7F, my leg muscles w...
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My arm became tender, I got chills at 330am on 1/12, my temp never got above 99.7F, my leg muscles were achy, felt weak, my neck was sore and I had a knot at the injection site. I took 400 mg of ibuprofen around 7am on 1/12 and my symptoms subsided until around 3pm and started getting chills and leg aches. My arm developed redness right where the knot is on my arm and I still have the knot today (1/13). I have had no other symptoms since 3pm 1/12.
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| 28 | 2021-01-12 | fever, cough, lethargy, shortness of breath, headache |
Same day extreme lethargy, woke up with severe muscle and joints pain, specifically my hips, genera...
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Same day extreme lethargy, woke up with severe muscle and joints pain, specifically my hips, general body weakness, headache, low grade fever 99.4 and taking Tylenol 01/9 still feel lethargic and 1/10 intermittent cough and heaviness when I breathe
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| 28 | 2021-01-12 | fever, chills, cold sweat | Systemic: Chills, Systemic: Fever, Systemic: Nausea, Systemic: clammy |
| 28 | 2021-01-12 | dizziness |
Systemic: dizziness,lump in throat, difficulty swallowing, numbness of lip area; symptoms lasted 0 d...
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Systemic: dizziness,lump in throat, difficulty swallowing, numbness of lip area; symptoms lasted 0 days
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| 28 | 2021-01-12 | fever, headache, skin warm, fatigue |
at about 20 hours post vaccination I had onset of fatigue, generalized body aches, joint aches, head...
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at about 20 hours post vaccination I had onset of fatigue, generalized body aches, joint aches, headache, and felt febrile. I took my temperature twice in the absence of antipyretics and did not have a fever (98.7 and 98.2) but my skin felt hot and painful as it does when I have had a fever in the past. By about 5:00 or around 24 hours post vaccination, all symptoms resolved aside from fatigue and headache, but the headache was less than it was before. I experienced those symptoms for the rest of the evening and woke up this morning feeling completely normal.
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| 28 | 2021-01-12 | headache, fever, chills | body aches, lower back pain, headache, chills, fever, nausea |
| 28 | 2021-01-12 | fever, dizziness, headache |
dizziness; nausea; joint pain; itching and broke out in rash around injection site; itching and brok...
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dizziness; nausea; joint pain; itching and broke out in rash around injection site; itching and broke out in rash around injection site; pain and stinging on injection site location; heat and redness as well as a raised rash; heat and redness as well as a raised rash; Both ears got, rot and itchy, stomach itchy; Both ears got, rot and itchy, stomach itchy; fever of 100.7; sever heart burn; severe body aches; head ache; raised rash; This is a spontaneous report from a contactable other Health Care Professional (HCP) who is the patient. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown, expiration date unknown) via an unspecified route of administration on 04Jan2021 at 10:00 AM (at the age of 28-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included removal of a metastatic carcinoid tumor from an unknown date and unknown if ongoing. The patient's allergies include minor hive breakouts from "several things." The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) via an unspecified route of administration on 17-DEC-2020 at 14:00 (at the age of 27-years-old) at an unspecified dose in the right arm. The patient was not pregnant at the time of this vaccination. The patient was administered the vaccine in the hospital. Prior to this vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included drospirenone;ethinylestradiol;levomefolic acid (reported as "generic form of Beyaz") and acetaminophen.The patient did not receive any other vaccines within four weeks prior to the first vaccination. On 04Jan2021 at 10:00 PM the patient experienced severe body aches and head ache, through out that night. She had dizziness and nausea with increased joint pain and body aches with the head ache increasing as well. On the morning of 05Jan2021 she experienced a fever of 100.7 and body aches. On that same day in the afternoon these symptoms subsided. She also experienced severe heart burn on 05Jan2021 that did not subside with Tums. On Wednesday 06Jan2021 she was feeling much better, and she had a "normal day." At 12:00 AM on 07Jan2021 the patient started itching and broke out in a rash around the vaccination site, and pain and stinging at injection site. She also had heat and redness as well as a raised rash. Both ears got, hot and itchy, her stomach was itchy but not red or swollen, same for the right leg and foot. She took one allergy pill, and twenty minutes later was still having a bad reaction so she took another allergy pill. She stayed awake to fill out this form, and she was hoping the reaction would stop spreading. Treatment was reported as having taken Tums for the severe heart burn and the patient also took an unspecified "allergy pill" for the itching, vaccination site rash, pain and stinging, the heat, redness and raised rash, the red, hot itchy ears, and the itchy stomach. The clinical outcome of the events severe body aches and fever was reported as recovered on 05Jan2020. The clinical outcome of headache, dizziness, nausea, joint pain, heartburn, vaccination site rash, vaccination site pruritus, vaccination site pain, feeling hot, redness, itchy, ear disorder and raised rash was reported as recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 28 | 2021-01-12 | nasal congestion, fatigue | lymphadenopathy Nasal congestion Allergy Fatigue |
| 28 | 2021-01-12 | fever, chills, dizziness |
severe body aches -- started at 07:50 PM 1/12/21 and remained until Tylenol was taken (7 AM 1/13/21)...
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severe body aches -- started at 07:50 PM 1/12/21 and remained until Tylenol was taken (7 AM 1/13/21) Fever/chills -- started at 12:30 AM 1/13/21 and remained until Tylenol was taken (7 AM 1/13/21) nausea, dizziness -- started at 6:00 AM 1/13/21 and remained until breakfast was eaten with large glass of cold water
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| 28 | 2021-01-13 | cough, fever, headache, shortness of breath, chills |
1/11/2021 9:00pm - injection site arm sore, body aches, fever up to 100.8 degrees Fahrenheit, chills...
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1/11/2021 9:00pm - injection site arm sore, body aches, fever up to 100.8 degrees Fahrenheit, chills, and headache. 1/12/2021 8:00am - severe body aches, fever up to 101.0 degrees Fahrenheit after takingTylenol and chills. 1/12/2021 6:00pm - fever 100.6 degrees Fahrenheit after taking Tylenol, shortness of breath, and deep dry cough. 1/13/2021 11:00am -shortness of breath, deep dry cough worsening with tachycardia. Went to urgent care diagnosed with upper respiratory infection due to second covid vaccine reaction prescribed prednisone.
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| 28 | 2021-01-13 | fatigue, chills, fever |
2nd vaccine on Tuesday. Wednesday started to have symptom: fatigue, chill and fever. Today 12/14/2...
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2nd vaccine on Tuesday. Wednesday started to have symptom: fatigue, chill and fever. Today 12/14/2021 only fatigue.
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| 28 | 2021-01-13 | fever, headache, fatigue |
About 27 hours after my vaccine (at about 9 pm on 01/12) I began having 8-10/10 chest pain. Mostly b...
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About 27 hours after my vaccine (at about 9 pm on 01/12) I began having 8-10/10 chest pain. Mostly burning sharp pain, but some restricting tight pain as well, radiating to my back mostly. It would be relieved for maybe 10 minutes at a time but then flare back up for about 5 hours. I went to the emergency room, where they did a cardiac work up including blood work and EKG, vitals and a chest X-ray, all which were unremarkable. At about 0200 am on 01/13, the pain subsided. Previous to the chest pain, during the morning and afternoon of 01/12, I had a low grade fever (99.9 F), an intense headache, and fatigue. 01/14/21 sore swollen lymph node under L arm.
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| 28 | 2021-01-13 | sweating, chills, malaise, fatigue, headache | Chills, sweating, throbbing headache, terrible body aches, fatigue, malaise, sore left arm |
| 28 | 2021-01-13 | chills, headache, fatigue, dizziness |
Chills; Dizziness; Soreness at injection site; Fatigue; Muscle aches; Headache; TMJ aching (joint pa...
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Chills; Dizziness; Soreness at injection site; Fatigue; Muscle aches; Headache; TMJ aching (joint pain); Mild back pain on injection side; This is a spontaneous report from a contactable Nurse (the patient). A 28-year-old female patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3246, expiration date unknown) via an unspecified route of administration on 05Jan2021 at 08:45 (at the age of 28 years old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included COVID-19 on an unspecified date, allergy to Penicillin and seasonal allergy from unknown dates.The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. Prior to the vaccination, the patient was diagnosed with COVID-19 (date not specified) The patient's historical vaccines include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK5730, expiration date unknown) on 15Dec2020 at 3:00 PM (at the age of 28 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient was tested for COVID-19 after the first vaccination in the form of a nasal swab test on 24Dec2020 which was negative. Concomitant medication included cetirizine hydrochloride (ZYRTEC), biotin (BIOTIN), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports having experienced a headache five (5) hours post the second vaccine, soreness at injection site, fatigue and muscle aches eight (8) hours post the second vaccine, chills and dizziness twelve (12) hours post the second vaccine, and TMJ aching and mild back pain on injection side twenty-four to forty-eight (24-48) hours post the second vaccine. Treatment was received for the events and included acetaminophen and ibuprofen.The clinical outcome of the events headache, vaccination site soreness, fatigue, muscle aches, chills, dizziness, joint aching and back pain was reported as recovered on an unspecified date in Jan2021. It is unknown if the patient has been tested for COVID-19 since the second vaccination.
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| 28 | 2021-01-13 | shortness of breath, throat swelling, cough |
Day after vaccine : mild shortness of breath, sensation of swelling in my throat/neck area. Took Ben...
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Day after vaccine : mild shortness of breath, sensation of swelling in my throat/neck area. Took Benadryl 50mg before bedtime. 2 days after vaccine: woke up with voice changes, coughing/choking with speaking. Used epipen once, felt full relief for about 1-2 hours. Trouble speaking again. Then went to ER, had epipen again twice, over two hours, Benadryl 50IV and Pepcid and steroids. Sitting in the ER now debating admission. Likely being admitted., home epipen are too expensive to treat q2h by myself.
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| 28 | 2021-01-13 | fatigue |
Fatigue on the same day of the vaccine and the next day. Left arm soreness for about 2-3 days after ...
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Fatigue on the same day of the vaccine and the next day. Left arm soreness for about 2-3 days after the vaccine.
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| 28 | 2021-01-13 | sweating |
I received the second dose of the Pfizer vaccine on 1/8/2021. The following day I had mild hives on ...
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I received the second dose of the Pfizer vaccine on 1/8/2021. The following day I had mild hives on my neck and thigh creases, I attributed it from sweating, hives went away after taking Claritin. The evening of 1/11/2021 I had 1 glass of wine and subsequently broke out into hives all over my chest and neck, took Benadryl that night. In the morning of 1/12/2021 the hives had worsened. I started Prednisone 40mg, Claritin, Pepcid 20mg in the AM and Prednisone 20mg, Benadryl, Pepcid 20mg at night. The following day the hives had mostly resolved and I only took the OTC medications. In the afternoon of 1/13/2021 I rode my stationary bike. After the ride I had broke into hives again on my chest and neck and where my headband sat. I then took Prednisone 40mg, Benadryl 25mg, Pepcid 20mg. Hives have mostly resolved today 1/14/2021, still have the sensation of itchiness. Never had throat closing or shortness of breath.
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| 28 | 2021-01-13 | throat irritation, cough |
Patient began itching on chest and showing hives on upper arms. Patient then was learing throat, cou...
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Patient began itching on chest and showing hives on upper arms. Patient then was learing throat, coughing, tingling in the tongue. Itchiness progressed down arms, as did hives. EMS arrived and administered 0.3 mg Epi IM and IV Benadryl. Vitals obtained.
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| 28 | 2021-01-13 | fever, chills |
Symptoms - ? Patient reports at 02:00 + fever of 106 (1000 mg Tylenol taken at 03:00) and + fever of...
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Symptoms - ? Patient reports at 02:00 + fever of 106 (1000 mg Tylenol taken at 03:00) and + fever of 104 at 08:00 (1000 mg Tylenol taken at 08:15), + chills. Last day of work and shift - unknown Home remedies? - see ?symptoms? for narrative Any improvement? - mild Recommendation? Patient educated to continue to monitor her symptoms and to contact EH vaccine support line with further questions and concerns. Patient educated to continue to rotate Tylenol and motrin as indicated in the Medical Directive provided by employer and to notify her manager she will be unable to report to work until she is fever free for 24 hours without the use of an antipyretic. Patient educated to continue to manage per Employer Illness in the Workplace Policy. Patient verbalized back understanding and denied further questions at this time.
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| 28 | 2021-01-13 | chills |
joint pain; Chills; body aches; This is a spontaneous report from a contactable other hcp. A 28-yea...
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joint pain; Chills; body aches; This is a spontaneous report from a contactable other hcp. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: EK5730, intramuscular in the right arm, from 06Jan2021 16:15 to 06Jan2021 16:15 at a single dose for covid-19 immunization. The patient medical history was not reported. Historical vaccine included BNT162B2 on 17Dec2020. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. On 07Jan2021 12:00, the patient experienced joint pain, chills and body aches. The outcome of events was recovering. No treatment was received due to events. No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
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| 28 | 2021-01-13 | fatigue, headache |
same day: pain at injection site next day: headache, fatigue, paint at injection site, muscle aches ...
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same day: pain at injection site next day: headache, fatigue, paint at injection site, muscle aches 2 days after: no symptoms
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| 28 | 2021-01-14 | fever |
Around 7:30 PM on 1/11/2021, patient started to experience fever, diffuse sharp chest pain with body...
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Around 7:30 PM on 1/11/2021, patient started to experience fever, diffuse sharp chest pain with body aches, and myalgias. Patient was COVID+ in October 2020. Patient presented to the emergency department and was treated as a sepsis alert and received fluids, ceftriaxone, and ibuprofen with good response. Labs were as follows: Bilirubin and transaminases are normal, D-dimer is normal, serum lactate is normal, EKG is nondiagnostic with prolonged QT, troponin is negative.
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| 28 | 2021-01-14 | headache, body temperature increased, chills | BODY ACHES, CHILLS, TEMP 101.5, HEADACHE |
| 28 | 2021-01-14 | fever, chills, headache |
EMPLOYEE REPORTED BEGAN ROUGHLY 12 HOURS FOLLOWING VACCINATION: BODY ACHES, CHILLS, TEMP 101.5, HEA...
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EMPLOYEE REPORTED BEGAN ROUGHLY 12 HOURS FOLLOWING VACCINATION: BODY ACHES, CHILLS, TEMP 101.5, HEADACHE. RESOLVED WITHIN 48 HOURS.
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| 28 | 2021-01-14 | chills, fever, weakness, dizziness |
Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back...
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Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; This is a spontaneous report from a contactable other-HCP (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1686), via an unspecified route of administration on 07Jan2021 13:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient is not pregnant. The facility type vaccine was hospital. Patient took the first dose of BNT162B2 on 17Dec2021 13:45 (lot number EK5730) at arm left for covid-19 immunization. The patient medical history was not reported. Concomitant medication included famotidine and birth control. The known allergies included Cefzil. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain on 08Jan2021 00:15 with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
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| 28 | 2021-01-14 | night sweats, fever, chills | Fever, chills, myalgia, muscle weakness, night sweats x3 days |
| 28 | 2021-01-14 | chills, fever, headache | Headache, body aches, nausea, chills, fever - 48 hours |
| 28 | 2021-01-14 | headache, fever, chills | Headaches and full body aches x 2 days, chills and fever two nights in a row |
| 28 | 2021-01-14 | sweating |
Hours after first COVID vaccine 12/18 developed facial and lip swelling then urticaria on arms and n...
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Hours after first COVID vaccine 12/18 developed facial and lip swelling then urticaria on arms and nonpruritic, erythematous rash chest to thighs. Woke that night with tachycardia to 220's. Tachycardia of varying degree and severe diaphoresis was constant through the next 72 hours. Did not seek care. Since then, for 3 weeks she has had multiple runs of SVT. Last one was Saturday 1/9 - went to ER, episode recorded. Given rx of xanax which did not resolve her tachycardia. Established care with me 1/14/2021 and noted to have 3/6 systolic murmur. Patient (who is a PA) states it is significantly louder than it was prior to vaccination. Given rx of prn propranolol for home, outcome pending
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| 28 | 2021-01-14 | chills |
I was awoken from sleep with violent chills and an sensation of severe cold. My chills became violen...
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I was awoken from sleep with violent chills and an sensation of severe cold. My chills became violent and coarse rigors, severe enough to contract the spine into hyperextension if I kept my body in a neutral position. I could still activate each muscle group to keep in a fetal prostration pose. I was knowledgeable of the event, did not loose any bowel, bladder, or smooth muscle function, and the intensity of the rigors was focused on the most developed skeletal muscles (thighs, calves, upper arms, forearms, paraspinal muscles, hands, respectively). Jaw and muscles of the head/face seemed unaffected. Fingers and toes not distinctly affected. I was not sweating at this time and there were NO other symptoms to report; I remained lucid and able to self-reflect the entire time. Home temperature is kept to consistent 66F, no malfunctions to thermostat. No recent changes to bedding (sheet and quit on top of mattress); it is even optimized for me as I tend to overheat as I sleep. At 50 minutes, I felt "less frozen" and confident enough to stand/ambulate for 220mg naproxen + 500mg APAP , cautiously and successfully swallowed. Robe was donned over existing pajamas and thick comforter was pulled from hallway closet. Rigors continued, but it appeared that intentional activation of the muscle groups could still overpower the rigors for safe (but shaky) ambulation. Greatest risk was coarsely shaking hands a bringing cup to mouth to swallow pills. Above activity was completed in 5 minutes. I then sat upright in bed under layers above. I could feel the muscles calm and relax, with episode completely ending in 5 minutes. Total time of event: 60 minutes. Post-event details: There was a mild sensation of muscle tension in the posterior cervical spine akin to whiplash, but no residual symptoms. I debriefed with my husband shortly thereafter (he has been in another room the whole time) and fell asleep by 23:30. Awoke to alarm at 05:00 and able to stretch, accomplish 30 min run, vacuum/mop the floors, and present to work by 08:00am without deficit. Time of documentation: 11:22 am 1/15/2021
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| 28 | 2021-01-14 | fatigue, malaise, headache, fever, chills |
Injection site pain, malaise, headache, chills, fatigue, low grade fever, swollen lymph nodes, skin...
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Injection site pain, malaise, headache, chills, fatigue, low grade fever, swollen lymph nodes, skin tingling, joint pains, muscle aches
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| 28 | 2021-01-14 | chills, headache, fever | MAX TEMP 101.5, CHILLS, BODY ACHES, HEADACHE. ALL RESOLVING WITHIN APPROXIMATELY 48 HOURS. |
| 28 | 2021-01-14 | dizziness |
Nausea, lightheaded, elevated BP. Went home and started having body aches, joint pain. Improved naus...
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Nausea, lightheaded, elevated BP. Went home and started having body aches, joint pain. Improved nausea.
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| 28 | 2021-01-14 | headache, fatigue, fever, chills |
Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, mu...
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Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; This is a spontaneous report from a contactable other HCP. A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 08Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included postural orthostatic tachycardia syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of bnt162b2 (anatomical Location: Arm Left) on 18Dec2020 09:30 and experienced headache, arm pain. Concomitant medication included spironolactone and metoprolol. The patient experienced events after the second dose: fever, chills, muscle and joint pain, headache, fatigue on 08Jan2021 21:00. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering. Information about lot/batch number has been requested.
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| 28 | 2021-01-14 | headache, fever, chills |
Symptoms - ? Patient reports around 10:00 PM on 1/13 began with chills, HA, body aches, and fever (T...
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Symptoms - ? Patient reports around 10:00 PM on 1/13 began with chills, HA, body aches, and fever (Tmax 100.8), re-checked her temp approx. 2 hrs later, 102.3 and took Tylenol at that time. Thursday: 09:00 fever (Tmax 101) which resolved with tylenol. Patient reporting concerns resolution of fever with Tylenol but once meds wear off, febrile again. Intermittent HA. Friday: woke up around 0700 with + fever (Tmax 101.2) and intermittent HA. Last day of work and shift ? next scheduled shift tonight? Home remedies? - Tylenol/motrin and rest Any improvement? ? mild improvement Recommendation? Patient encouraged to take ibuprofen and acetaminophen as outlined in the Medical Directive. Patient encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. Patient reports she is scheduled to return to work tonight. Patient educated policy of needing to be fever free for 24 without use of antipyretics prior to returning to work. Patient educated to notify manager and to manage her RTW according to the Hospital Illness in the Workplace policy. Patient verbalized back understanding and denied further questions at this time.
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| 28 | 2021-01-14 | fever, chills |
The night of receiving the vaccine, I developed chills and myalgia that progressively got worse into...
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The night of receiving the vaccine, I developed chills and myalgia that progressively got worse into the morning. Then I developed a fever of 38.6
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| 28 | 2021-01-14 | headache, fatigue, dizziness |
The unexpected reaction was localized constant left chest pain. It is believed to be due to swollen ...
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The unexpected reaction was localized constant left chest pain. It is believed to be due to swollen lymph nodes in the pectoral area (as all other testing at the ER was normal). Also sharp pain when breathing in deeply.
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| 28 | 2021-01-14 | sweating, headache |
Thursday night started with body aches, shot area started to hurt. The next morning woke up hot and ...
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Thursday night started with body aches, shot area started to hurt. The next morning woke up hot and sweaty with a headache and body aches
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| 28 | 2021-01-14 | headache |
headache; arm pain; This is a spontaneous report from a contactable other healthcare professional (p...
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headache; arm pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 18Dec2020 09:30 at a single dose on left arm for COVID-19 immunization. Medical history included Postural orthostatic tachycardia syndrome. Concomitant medication included spironolactone and metoprolol. The patient experienced headache and arm pain on an unspecified date after first dose (reported as "First dose: headache, arm pain"). No treatment received for adverse events. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/ batch number has been requested.
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| 28 | 2021-01-15 | chills, fever |
24 hours after getting the vaccine, had whole body chills followed by fever to 101.3 F. Had diffuse ...
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24 hours after getting the vaccine, had whole body chills followed by fever to 101.3 F. Had diffuse arthralgias and myalgias. Mild improvement with acetaminophen.
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| 28 | 2021-01-15 | malaise |
Dose 1 was on 12/16/2020, 9 days after on Christmas I became violently ill with what I assumed to be...
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Dose 1 was on 12/16/2020, 9 days after on Christmas I became violently ill with what I assumed to be a 24 hour stomach flu or food poisoning and was vomiting approximately every 15 minutes for about 3 hours. Today 1/15/2021, 9 days after my second dose of the vaccine I again became violently ill, vomiting about every 15 minutes for approximately 3-4 hours. I reported it once I noticed the coincidence.
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| 28 | 2021-01-15 | fever, headache, chills, fatigue, dizziness |
Got vaccine at noon with no pain. Was completely fine until 1:30am then began with chills/tremors, f...
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Got vaccine at noon with no pain. Was completely fine until 1:30am then began with chills/tremors, fever, headache, nausea and 1 episode vomiting, myalgia throughout body, dizzy/lightheaded ness and extreme fatigue. The next day Jan 16 had diarrhea all morning
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| 28 | 2021-01-15 | fever, weakness, fatigue | Muscle aches, low grade fever of 99.8 F, vomiting, weakness and fatigue. |
| 28 | 2021-01-15 | fatigue, headache, chills, somnolence |
Several hours after receiving the vaccination, I became fatigued and sore with muscle aches in the a...
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Several hours after receiving the vaccination, I became fatigued and sore with muscle aches in the arm of the vaccine site. That night I woke up with moderate body aches and chills and a dull headache, no fever. The next morning, I awoke feeling very fatigued, severe muscle/body aches, headache and chills, still no fever. I slept most of the day. Extra strength Tylenol helped tremendously with the body aches. I was symptom free the morning of 1/15/2021. I was scheduled to work the day after my vaccination and was unable to due to the symptoms described. I had no adverse reactions with my first dose. I am a nursing mother and for the first and second doses, I noticed no side effects or any concerns with my child or milk supply.
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| 28 | 2021-01-16 | headache, migraine |
2 hours after the administration of the vaccine, the left side of my face briefly started to tingle....
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2 hours after the administration of the vaccine, the left side of my face briefly started to tingle. I slept for 6 hours, and when I woke up, the left side of my face was noticeably having pins and needles. I took 25 mg of oral Benadryl and slept for another 7 hours, and when I woke up, my left arm and leg were experiencing pins and needles. The left side of my face was completely numb, and I felt like that side was being pulled down toward the floor. The left, posterior side of my head felt very tingly, and I had a pounding headache behind the left eye that worsened with light. My boyfriend noticed my smile being different, and after looking in the mirror, I decided to go to ED. They were concerned about Bell's Palsy, but with the extremity involvement, they changed my plan of care to a migraine response from the vaccine. I received an MRI, IV Compazine and IV Toradol. My headache went from a 6/10 to a 2/10 after that treatment, but it came back soon after my discharge.
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| 28 | 2021-01-16 | chills, headache, fever | Fever, chills, headache, body aches, left axillary lymph node swelling |
| 28 | 2021-01-17 | headache, chills, fever, dizziness |
At hour 8, spiked fever to 103 degrees fareinheit; Also have had intense chills, aches, headache, di...
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At hour 8, spiked fever to 103 degrees fareinheit; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Approximately 6 hours after injection felt body aches and chills.; Approximately 6 hours after injection felt body aches and chills.; This is Spontaneous report from a Non-contactable Nurse. A 28-years-old female (no pregnant) patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular on 08Jan2021 09:00 at the second single dose at Arm Right for covid-19 immunisation. Medical history included birth control. Concomitant medication included vitamin d3 (VITAMIN D3), ethinylestradiol, norethisterone (NORTREL) for birth control, and multivitamin. The patient previously took phenergan and experienced drug hypersensitivity, the first bnt162b2 on 18Dec2020 and experienced very mildly sore arm at injection site. On 08Jan2021 received dose #2. Approximately 6 hours after injection felt body aches and chills. On 08Jan2021 17:30, spiked fever to 103 degrees Fahrenheit. Fever stayed greater then 100 degrees with spikes to 103 for over 48 hours despite usage of antipyretics and cold compresses. Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite. No local reaction at site noted. The patient did not received treatment for other events, except for Fever. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
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| 28 | 2021-01-17 | chills | Chills, Racing Heart, Dry Mouth, |
| 28 | 2021-01-17 | throat irritation |
Pt. felt hot and flushed, she c/o itching of arms and back, also itching of throat but felt it calmi...
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Pt. felt hot and flushed, she c/o itching of arms and back, also itching of throat but felt it calming down after 10 minutes and drinking water. Her face did appear flushed but she also said it was flushed before she got the injection. No difficulty breathing, no obvious urticaria. She was emotional about losing her mom to anaphylaxis at age 10, stated that her sister also has similar allergy profile. She questioned if she should et the second vaccine dose.
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| 28 | 2021-01-17 | weakness, shortness of breath, headache, dizziness |
difficult breathing; Pain on the chest; Not being able to move my upper neither lower body; itchines...
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difficult breathing; Pain on the chest; Not being able to move my upper neither lower body; itchiness all over my body; unconscious; Headaches; major anxiety; depression; very light-headed; weak; almost faint; This is a spontaneous report from a contactable Other HCP (patient). A 28-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 12:00 at single dose on Left arm for COVID-19 immunisation. Facility type vaccine was Hospital. Medical history was none. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced Not being able to move my upper neither lower body, Headaches, major anxiety, and depression, unconscious, very light-headed, weak, almost faint, Pain on the chest, difficult breathing, itchiness all over my body on 08Jan2021. AEs resulted in Emergency room/department or urgent care, Hospitalization. Received injected fluids as treatment. The outcome was Not Recovered. No COVID prior vaccination. No COVID tested post vaccination. Information on the lot/ batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 28 | 2021-01-19 | chills, headache | Chills, nausea, body aches, joint pain, muscle aches, headache, swollen lymph nodes in neck |
| 28 | 2021-01-19 | migraine |
Deep muscle aches. Migraine headaches. Skin pain (hurts to be touched, anywhere, no just injection s...
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Deep muscle aches. Migraine headaches. Skin pain (hurts to be touched, anywhere, no just injection site)
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| 28 | 2021-01-19 | chills, fever |
FEVER, PAIN OF THE LEFT SIDE OF THE STOMACH, CHILLS. TOOK TYLENOL EXTRA STRENGTH TO RELIEVE SYMPTOMS...
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FEVER, PAIN OF THE LEFT SIDE OF THE STOMACH, CHILLS. TOOK TYLENOL EXTRA STRENGTH TO RELIEVE SYMPTOMS.
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| 28 | 2021-01-19 | headache, fatigue, malaise | Fatigue, malaise, headache |
| 28 | 2021-01-19 | fever, chills |
I have a fever of 102F, starting around 2pm, 24 hours after vaccine administration. I am at home, dr...
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I have a fever of 102F, starting around 2pm, 24 hours after vaccine administration. I am at home, drinking fluids and taking Tylenol. I just wanted to report it. Additionally, I have aches and chills, but I know that is expected.
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| 28 | 2021-01-19 | somnolence |
My daughter woke up at 2am and I started feeling like I would throw up and I sat down and blacked o...
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My daughter woke up at 2am and I started feeling like I would throw up and I sat down and blacked out and fell into our shower and hit my head and shoulder my husband had to shake me and wake me up and I also felt like I would have diarrhea- ER said it was a vasovagal event
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| 28 | 2021-01-19 | fever, headache | Nausea, fever, headache |
| 28 | 2021-01-19 | fatigue, fever |
On 12-28-2020, I felt pretty fatigued and developed a fever throughout the following day. I lost m...
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On 12-28-2020, I felt pretty fatigued and developed a fever throughout the following day. I lost most of my appetite and had quite a bit of diarrhea for about 24 hours. I went to the ER urgent care on 12-29-2020 in the evening. I was in the ER room for that evening then I was discharged.
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| 28 | 2021-01-19 | migraine, fatigue, chills, fever | R SIDED MIGRAINE, CHILLS, FEVER, MUSCLE ACHES, FATIGUE |
| 28 | 2021-01-20 | dizziness, sweating |
Sars-CoV-2 vaccine (pPp treatment under Emergency Use Authorization(EUA): pfizer Received COVID-19 V...
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Sars-CoV-2 vaccine (pPp treatment under Emergency Use Authorization(EUA): pfizer Received COVID-19 Vaccine at 10:45 AM. After 10 minutes post administration, while being monitored began feeling nauseated and c/o some dizziness. Denies allergies or prior events with vaccination. A& O x3, pale, diaphoretic, weak radial pulse, cool w/ delayed cap refill. Preferred to sit with her head lowered rather than supine. VS noted and cool cloths provided. Stated she ate a little this AM, BP and pulse normally low for her and currently on menstrual cycle. Advised to stay additional 15 min. VS rechecked w/o change in symptoms. Agreed to lay supine, color improved and symptoms resolved. Declined calling MERT or 911 unless she had a change in her condition. Moved to sitting position, tolerated well asymptomatic. Stood became symptomatic, returned to sitting upright in chair. Continued dizziness, pale and nausea, A&O x3. Agreed to be seen in ER, departed in wheel chair with RN (Adult ER) to be evaluated. Time B/P Pulse Resp Position Notes 10:55 98/59 59 16 Sitting/Chair Pale, cool extremities, vertigo; additional monitoring 11:00 89/56 66 14 Sitting/Chair Pale, vertigo- moved to supine position 11:05 98/65 60 12 Supine Symptoms improving 11:12 103/70 76 16 Sitting Symptoms resolved 11:18 Sitting Stand, symptoms returned- changed to sitting to w/c Departed Vaccine Clinic area at 11:20 A&O x3, pale, intermittent dizziness in wheel chair to Adult ER. Charge Nurse notified.
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| 28 | 2021-01-20 | chills, fatigue, fever |
severe chills, fatigue, fever 100.7F, nausea; severe chills, fatigue, fever 100.7F, nausea; severe c...
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severe chills, fatigue, fever 100.7F, nausea; severe chills, fatigue, fever 100.7F, nausea; severe chills, fatigue, fever 100.7F, nausea; severe chills, fatigue, fever 100.7F, nausea; This is a spontaneous report from a non contactable physician reporting for herself. A 28-years-old female patient received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 19Dec2020 17:00 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced severe chills, fatigue, fever 100.7°F, nausea on an unknown date with outcome of recovering. The patient underwent lab tests and procedures which included body temperature: 100.7 Fahrenheit on an unspecified. Unspecified therapeutic measures were taken as a result of the reported events. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
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| 28 | 2021-01-21 | chills |
12/23/20 1ST DOSE (AFTERNOON/EVENING): CHILLS, BODY ACHES, TEARING/CRYING. BACK PAIN 1/12/21 2ND DOS...
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12/23/20 1ST DOSE (AFTERNOON/EVENING): CHILLS, BODY ACHES, TEARING/CRYING. BACK PAIN 1/12/21 2ND DOSE (AFTERNOON/EVENING): WORDS/CHALLENGES COMMUNICATING FOR 24 HRS
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| 28 | 2021-01-21 | headache |
6 hours - 36 hours after vaccine (starting day of) body aches and headaches 47 hours after vaccine...
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6 hours - 36 hours after vaccine (starting day of) body aches and headaches 47 hours after vaccine heart palpitations requiring an emergency department visit
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| 28 | 2021-01-21 | chills, sweating, migraine | Body Aches, Chills, Sweats, Migraine, light sensitivity |
| 28 | 2021-01-21 | fever, headache | Fever, headache. Improved. |
| 28 | 2021-01-21 | headache, respiratory tract congestion | Headache, body ache and congestion |
| 28 | 2021-01-24 | sweating, headache, dizziness |
13:21 -vaccine administered 13:40-c/o HA, nausea, dizziness, "hot, sweaty," diaphoretic HR116 BP 135...
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13:21 -vaccine administered 13:40-c/o HA, nausea, dizziness, "hot, sweaty," diaphoretic HR116 BP 135/80 13:45-HR 107 BP 126/74 with worsening HA, persistent nausea.
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| 28 | 2021-01-24 | discomfort, chills, headache, fever, sweating, fatigue |
Covid Vaxx #2 1/20 0815 - shot 12:15 - sore arm 1600 - mild aches and fatigue 1800 - 2cm nodule and...
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Covid Vaxx #2 1/20 0815 - shot 12:15 - sore arm 1600 - mild aches and fatigue 1800 - 2cm nodule and redness at injection site 2015 - moderate aches and fatigue, feel like fever is coming 98.2 2130 - severe aches and fatigue, feels like flu 99.2 fever and chills 2300 - can?t sleep, extremely uncomfortable 100.5 1/21 0030 - hot, more uncomfortable and exhausted, need sleep 101.0 took 600mg Advil 0500 - slept ~4 hours, woke up uncomfortable again, temp 99.5 with chills 0730 - woke up hot and uncomfortable, temp 100.0 0930 - woke up hot and uncomfortable, headache and chest tightness, severe back pain, temp 100.5, took Tylenol and ate sandwich 1130 - woke up, hungry, still uncomfortable but okay, temp 98.5 1355 - sudden severe chest pain 1455 - showered and laid down, chest pain subsided, took nap temp 98.5 1610 - woke up hot achy and uncomfortable, temp 101.0 1630 - took Tylenol 2145 - sudden severe chest pain, went to bed, no fever 2330 - chest pain subsided, haven?t slept yet 1/22 0200 - slept for an hour or two, woke up slightly warm, temp 99.7 0500 - woke up sweating, feeling slightly better, temp 98.7 0900 - No more fevers after this point, injection site swollen and raised ~5 cm circle, red and hot to touch, itchy Benadryl helps 1/23 99% better, only symptoms left are injection site soreness and itchiness, and intermittent right sided neck pain relieved with ibuprofen
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| 28 | 2021-01-24 | chills |
Severe shaking about 12 hours after injection. Started as shivering and turned into full body convul...
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Severe shaking about 12 hours after injection. Started as shivering and turned into full body convulsions lasting just over an hour. Bundling up in blankets did not help as shaking intensified. Only other side effect was a sore arm at injection site.
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| 28 | 2021-01-24 | headache, fatigue |
Very sore arm the following day (difficulty using and lifting) and tired. Then two days later work ...
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Very sore arm the following day (difficulty using and lifting) and tired. Then two days later work up with headache and nausea.
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| 28 | 2021-01-24 | influenza like illness, malaise, throat pain, headache |
can't even think; no sense of smell; sick; headache; flu type symptoms with sinus pressure; flu type...
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can't even think; no sense of smell; sick; headache; flu type symptoms with sinus pressure; flu type symptoms with sinus pressure; sore throat; brain fog; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 28-year-old female patient received BNT162b2 (lot number: EL3246), via an unspecified route of administration in left arm on 09Jan2021 at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient got the COVID 19 vaccine on 09Jan2021, and symptoms started shortly right after, with headache, flu type symptoms with sinus pressure, all on 09Jan2021; and this morning (13Jan2021) she woke up with no sense of smell. She is so sick right now (13Jan2021), said she can't even think right now (13Jan2021). The patient stated the only thing that improved was the headache went away, and in the first two days (Jan2021), she had a sore throat, and that has gone away, but everything else has stayed constant. The patient had brain fog in Jan2021. The patient underwent lab tests and procedures which included weight: 125 pound range. The outcome of the event headache was recovered on 09Jan2021, the sore throat was recovered in Jan2021, other events was not recovered.
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| 28 | 2021-01-24 | fever, headache, chills |
sore arm at the injection site; I then woke up with a headache and had a fever with chills. Max temp...
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sore arm at the injection site; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EK9231) , via an unspecified route of administration on 06Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her 1st dose on 16Dec2020 (lot no: EH9899) administered on left arm. Patient was not pregnant. The patient has no COVID prior vaccination. On 07Jan2021, patient stated "I had a sore arm at the injection site. I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2- 100.4 for majority of day and decreased to 99.6 that night. It only lasted the day after being vaccinated" The patient recovered on unspecified date from all of the events. The patient has not tested COVID on post vaccination. No follow-up attempts are possible. No further information is expected.
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| 28 | 2021-01-24 | headache, dizziness, chills, weakness, fever, malaise |
weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more ...
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weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more than a normal vaccine; She had a fever then; This is a spontaneous report from a contactable nurse. This 28-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) at single dose at left deltoid for COVID-19 immunisation on 11Jan2021 at 4:30 pm. Relevant history included contraception. Family Medical History Relevant to AE(s) was none. Concomitant drug included ongoing ethinylestradiol, etonogestrel (NUVARING) for contraception for years. The patient experienced a headache, back ache, nausea and was almost passing out. She had the first dose of the vaccine on the 11Jan2021 at 4:30 PM and was in bed around 10:00 that night. She woke up at 5:00 AM on 12Jan2021 and didn't feel great, her arm was killing her more than a normal vaccine and she was nauseated at 5:30, which was not that horrible. She took some Tylenol. Then she got to work and around 9:00 she felt like she was going to get sick. She had horrendous nausea, chills, weakness, eye pain, headache/ head pain, and back pain. Her clothes hurt because the body aches were so bad. She felt like she was going to pass out, like a vasovagal. She went to urgent care because her manager didn't think it was side effect. She went and got swabbed (result unknown), whatever. She had a fever then. They told her it was a reaction to the vaccine. Her temperature was 101.6 degrees Fahrenheit when she went to Urgent care. She would say the fever started at 12:30PM on 12Jan2021. She did not know if fever would be ongoing because she was taking fever reducer and it was working. The events weakness, eye pain, head pain, and back pain were reported as serious since medically significant. The nausea was better around 2:00PM. The outcome of event nausea, Chills was and Weakness was resolved on 12Jan2021. The outcome of events eye pain, head pain, and back pain was resolving. The outcome of event 'her arm was killing her more than a normal vaccine' was recovering. The outcome of fever was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, weakness, eye pain, head pain, and back pain, and the administration the suspect vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 28 | 2021-01-25 | headache, weakness, fatigue |
Fatigue; Body aches; Headache; Weakness; This is a spontaneous report from a contactable Nurse (pati...
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Fatigue; Body aches; Headache; Weakness; This is a spontaneous report from a contactable Nurse (patient). This 28-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Ek4176) intramuscular on 12Jan2021 11:15 at single dose on Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number=Ej1685) intramuscular on 22Dec2020 at single dose on Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient experienced Fatigue, Body aches, Headache, Weakness on 13Jan2021 12:00 AM. The outcome was Recovering. No treatment received for the adverse event. All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.
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| 28 | 2021-01-25 | headache, fatigue, chills, fever |
Headache; Myalgia; Fever; Fatigue; The patient experienced chills overnight; This is a spontaneous r...
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Headache; Myalgia; Fever; Fatigue; The patient experienced chills overnight; This is a spontaneous report from a contactable pharmacist (patient). A 28-year-old no pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231), intramuscular in left arm on 06Jan2021 17:45 at single dose for COVID-19 immunization. None Medical history included. Concomitant medication included sertraline and ethinylestradiol, norethisterone acetate (MICROGESTIN). The patient experienced chills overnight (06Jan2021). On 07Jan2021 02:00 am, she experienced fever, headache, myalgia, and fatigue. Self-treated with Acetaminophen. The outcome of events was recovered at unspecified time on 07Jan2021.
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| 28 | 2021-01-25 | fatigue, shortness of breath |
Labored breathing/shortness of breath; Extreme fatigue; Resting heart rate 104 bpm; Full body myalgi...
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Labored breathing/shortness of breath; Extreme fatigue; Resting heart rate 104 bpm; Full body myalgias; Nausea; This is a spontaneous report from a contactable pharmacist. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular at the left arm on 09Jan2021 17:00 at a single dose for COVID-19 immunization at a clinic. Medical history was reported as none. Patient has no known allergies. The patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (VELIVET). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at the left arm on 21Dec2020 14:45. The patient experienced full body myalgias, nausea, extreme fatigue, resting heart rate 104 bpm, and labored breathing/shortness of breath on 10Jan2021, 04:30. There was treatment for the adverse events. Patient has not been tested for COVID 19 prior and post vaccination. The patient was recovering from the events.
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| 28 | 2021-01-25 | dizziness |
Upon administration of the vaccine, patient reported 4/10 pain in injection arm, muscle soreness in ...
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Upon administration of the vaccine, patient reported 4/10 pain in injection arm, muscle soreness in their neck, and dizziness. Care was managed on-site by EMS and patient refused transport to hospital. Signed refusal of EMS transport states non-urgent acuity at time of discharge.
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| 28 | 2021-01-25 | dizziness |
Vertigo. Patient presented with lightheadedness and dizziness with associated body tremors. Symptoms...
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Vertigo. Patient presented with lightheadedness and dizziness with associated body tremors. Symptoms started 5-10 minutes after patient received her 2nd Pfizer vaccine dose. Patient has h/o vertigo and reported vertigo, headache, nausea, and emesis following the first vaccine dose. Unsure if syncope 2/2 vaccine vs vaccine adminitration anxiety vs h/o vertigo. NS bolus, Benadryl, Ativan, Tylenol, and Motrin were given. Normal EKG. Symptoms improved and patient discharged from the ED.
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| 28 | 2021-01-25 | headache, chills, fever |
fever of 102; chills; nausea; vomiting; headache; injection site pain; This is a spontaneous report ...
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fever of 102; chills; nausea; vomiting; headache; injection site pain; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 28-year-old female patient (no pregnancy) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), intramuscularly at site of left arm at 07:00 on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 (lot number: EL3248), intramuscularly at site of left arm at 7:00 AM on 22Jan2020 for COVID-19 immunization and experienced injection site pain. The patient experienced fever of 102, chills, nausea, vomiting, headache and injection site pain, all at 23:00 on 12Jan2021. Facility type vaccine was in hospital. No other vaccine received in four weeks. No other medications received in two weeks. No treatment received for adverse event. Adverse reactions did not result any serious consequences. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
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| 28 | 2021-01-25 | chills |
nausea; chills; arm is swollen; This is a spontaneous report from a contactable consumer (patient). ...
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nausea; chills; arm is swollen; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 11Jan2021 11:30 in the left deltoid at single dose for COVID-19 immunization, administered in the hospital. Medical history included birth control. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 on 23Dec2020 administered in the left deltoid. Her arm was swollen as she noticed this morning (12Jan2021) when she woke up, about 07:00. She placed ice on it and the swelling had gone down a little. Nausea and chills started around 09:30 this morning. The outcome of the event arm was swollen was recovering; while outcome of the events nausea and chills was not recovered. Information on batch/lot number was requested.
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| 28 | 2021-01-26 | fatigue, fever | 103 degree fever (day 2), muscle aches, muscle weakness, fatigue for 4+ days thus far |
| 28 | 2021-01-26 | headache |
ADR to COVID-19 vaccine - moderate in severity headache and upper extremity numbness all the way thr...
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ADR to COVID-19 vaccine - moderate in severity headache and upper extremity numbness all the way through the fingers lasting for 2 hours.
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| 28 | 2021-01-26 | fever, fatigue, chills |
Fever (highest at 101.8); Chills; Moderate nausea; Fatigue; Muscle aches in injection arm; This is a...
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Fever (highest at 101.8); Chills; Moderate nausea; Fatigue; Muscle aches in injection arm; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), intramuscular in left arm, on 09Jan2021 at 17:30, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included ethinylestradiol/ ferrous fumarate/ norethisterone acetate (JUNEL FE). The patient previously took the first dose of BNT162B2 (Lot Number: EL0140) on 19Dec2020 (04:30 PM) for COVID-19 immunization (intramuscular in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. The most recent vaccine was administered in a hospital facility. On 10Jan2021 at 05:30 AM (day 1 post-dose number 2), the patient experienced fever (highest at 101.8) twice, chills, moderate nausea, fatigue, and muscle aches in injection arm. No treatment was administered for the events. Post-vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Jan2021.
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| 28 | 2021-01-26 | fever, chills |
Fever up to 102 after 12 hours of vaccine/Continuing fever throughout next day; low grade fever at 3...
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Fever up to 102 after 12 hours of vaccine/Continuing fever throughout next day; low grade fever at 36h; Aches; chills; This is a spontaneous report from a non-contactable physician (patient). A 28-year-old female patient received the second dose bnt162b2 (reported as COVID 19 vaccine, brand: Pfizer) via an unspecified route of administration in left arm on 11Jan2021 11:30 at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of report. The patient previously received the first dose of bnt162b2 on 21Dec2020 11:30 in left arm for COVID-19 immunization at age 28 years old; azithromycin and experienced allergies. No other vaccines were administered in four weeks. The patient was not covid tested post vaccination. On 11Jan2021 23:30, the patient experienced fever up to 102 after 12 hours of vaccine, aches, chills. Continuing fever throughout next day and still had low-grade fever at 36h. Treatment was not given for AEs. The patient was recovering from the events. No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
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| 28 | 2021-01-26 | shortness of breath, fever, weakness, dizziness, fatigue |
My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was ad...
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My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was admitted. I suddenly became light headed and felt very abnormal. Broke out in hives on my neck and face . They took me to the ER department and by the time they wheeled me down the hall I was white , very disoriented. Couldn?t open my eyes and went from slurred speech to I couldn?t speak at all and couldn?t swallow. My throat and closed and I was having a anaphylactic reaction . They administered epi pen , pepcide and steroids. Since then I have been very weak , running a fever , tired , dizzy . Can hardly walk and I get out of breath from standing or walking .My muscles are very sore and have spams . Almost last night I went to the ER due to theses symptoms lingering. I have been unable to work since the vaccine was administered to me .
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| 28 | 2021-01-26 | fever |
Tenderness at site Low grade fever; Tenderness at site Low grade fever; This is a spontaneous report...
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Tenderness at site Low grade fever; Tenderness at site Low grade fever; This is a spontaneous report from a non-contactable Nurse(patient). A 28-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: unknown), via an unspecified route of administration at left arm on 12Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included hypothyroidism. No COVID prior vaccination, no COVID tested post vaccination, no known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID), ethinylestradiol, norgestimate (SPRINTEC). No other vaccine received in four weeks.The patient experienced tenderness at site low grade fever on 13Jan2021 04:00. Facility type vaccine was hospital. No treatment received. Outcome was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
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| 28 | 2021-01-26 | headache, fatigue |
sore arm, headache, muscle aches, fatigue. Also breastfeeding and baby seems slightly more fussy tha...
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sore arm, headache, muscle aches, fatigue. Also breastfeeding and baby seems slightly more fussy than usual unsure if related.
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| 28 | 2021-01-27 | fatigue, chills, headache, fever |
Fevers, severe chills, headaches, nausea, arm pain and swelling of left arm (injection site). Fatigu...
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Fevers, severe chills, headaches, nausea, arm pain and swelling of left arm (injection site). Fatigue
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| 28 | 2021-01-28 | chills, fever |
Fever (100.5); abdominal pain; aches; muscle aches; chills; This is a spontaneous report from a cont...
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Fever (100.5); abdominal pain; aches; muscle aches; chills; This is a spontaneous report from a contactable healthcare professional who reported for herself. A 28-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3248) via an unspecified route of administration 13:15 on 14Jan2021, at left arm, for Covid-19 immunization. The patient received first dose at left arm 03:15 PM on 22Dec2020. The patient's medical history included vertigo. The patient had no known allergies and no Covid-19 prior to vaccination. Concomitant medications included meclozine, montelukast, mometasone furoate (NASONEX), atomoxetine hydrochloride (STRATTERA), and levocetirizine dihydrochloride (XYZAL). 02:00 AM on 15Jan2021, the patient developed fever (100.5), abdominal pain, aches, muscle aches, chills. No treatment was received. The patient had not tested for Covid-19 after immunization. Outcome of the events was not resolved at the time of reporting. The reporter considered that the events were non-serious.
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| 28 | 2021-01-28 | fever | Fever fluctuating between 99.7-100.7 for 6 hours |
| 28 | 2021-01-28 | migraine, headache |
Headache/headache feels like migraine; Headache/headache feels like migraine; This is a spontaneous ...
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Headache/headache feels like migraine; Headache/headache feels like migraine; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 (19:00) (Lot number: EH9899; Expiration date was not reported), and then the second dose on 12Jan2021 (18:45) (Lot number: EK4176; Expiration date was not reported), both intramuscularly on the left arm at a single dose for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On an unspecified date, after the first dose of vaccination, the patient had a headache/headache that felt like migraine. The patient had experienced a similar headache (headache that felt like migraine) on 17Jan2021, after the second dose of vaccination. The patient had received bultalbital, acetaminophen, caffeine (FIORICET) as treatment for the events. The outcome of the events, headache/headache that felt like migraine, was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination. No follow-up attempts are possible. No further information is expected.
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| 28 | 2021-01-28 | malaise, shortness of breath |
Right breast implant exploded and spread to her neck where she was having difficulty breathing/Right...
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Right breast implant exploded and spread to her neck where she was having difficulty breathing/Right breast implant erupted. Silicone in breast implant spread into her neck where patient was having difficulty breathing; Right breast implant exploded and spread to her neck where she was having difficulty breathing/Right breast implant erupted. Silicone in breast implant spread into her neck where patient was having difficulty breathing; This is a spontaneous report from a contactable Physician. A 28-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), intramuscular on 13Jan2021 10:00 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. Vaccine location was right arm. No prior vaccinations within 4 weeks. Patient called stating she wasn't feeling well. She was in the resident lounge and all of a sudden, the right breast implant just popped. Silicone in her breast implant spread into her neck where patient was having difficulty breathing on 14Jan2021. The patient was hospitalized on 14Jan2021, with pain medication and will have to have the implants removed. They think it is vaccine related. Patient was waiting for general surgery. The outcome of right breast implant exploded was unknown. The outcome of difficulty breathing was not recovered. Information on the Lot/batch number has been requested.; Sender's Comments: The reported breast implant rupture and associated difficulty breathing were more likely due to breast implant surgery and the quality of implant, and unlikely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 28 | 2021-02-01 | weakness, somnolence, shortness of breath |
Seizure; muscle spasm; weakness; hard to breathe at time; can't stay awake; This is a spontaneous re...
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Seizure; muscle spasm; weakness; hard to breathe at time; can't stay awake; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3346), via an unspecified route of administration at Left arm on 15Jan2021 08:00 at single dose for covid-19 immunization. Medical history included seizure, asthma, known allergies to penicillins and NSAIDs. Concomitant medication included levetiracetam, escitalopram, phenytoin, lamotrigine. The patient previously took naproxen, azithromycin, clindamycin; all experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 08:30, the patient experienced seizure, muscle spasm and weakness, hard to breathe at time, can't stay awake. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the seizure and other reported events due to temporal relationship. Of note, the patient has a medical history of seizure disorder. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 28 | 2021-02-04 | headache, fatigue |
After Dose 1 - mild headache, fatigue, arm soreness for 2 days After Dose 2 - mild headache, fatigue...
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After Dose 1 - mild headache, fatigue, arm soreness for 2 days After Dose 2 - mild headache, fatigue, arm soreness for 2 days. Appendicitis resulting in appendectomy 4 days later
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| 28 | 2021-02-07 | discomfort, weakness |
Passed out; fell; became disoriented and weak; became disoriented and weak; could not control her bo...
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Passed out; fell; became disoriented and weak; became disoriented and weak; could not control her body, all muscles felt heavy and weak; could not control her body, all muscles felt heavy and weak; Felt tingles in feet and lower legs; This is a spontaneous report from a contactable consumer(patient). The 28-year-old female patient(not pregnant) received first dose BNT162B2(COVID 19, lot number: EL9262), via an unspecified route of administration at left arm on 22Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included none. She had no known allergies. Concomitant medication included spironolactone, amfetamine aspartate/amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), vitamin b complex (VITAMIN B), ergocalciferol (VIT D), ZINC, omeg(omeprazole). There was no other vaccine in four weeks. About 11 hours after receiving(23Jan2021), she very quickly became disoriented and weak, could not control her body, all muscles felt heavy and weak. She fell once and then presumably passed out - she came to after falling again. She felt tingles in feet and lower legs. After sleeping about 9 hours, she felt better. There was no treatment received, no covid prior vaccination, covid tested post vaccination. Events were assessed as non-serious. Outcome of events was recovering.
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| 28 | 2021-02-11 | dizziness |
Lightheadedness within 5 minutes; weakness of muscles; rapid heart rate; This is a spontaneous repor...
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Lightheadedness within 5 minutes; weakness of muscles; rapid heart rate; This is a spontaneous report from a contactable other HCP reporting for herself. A 28-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , intramuscular on 25Jan2021 09:00 at single dose for Covid-19 immunisation . The patient medical history and concomitant medicatons were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient experienced lightheadedness, weakness of muscles and rapid heart rate on 25Jan2021 09:15 with outcome of recovering. The patient was treated in Emergency Room with steroids and anxiety medications. Information on the lot/batch number has been requested.
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| 28 | 2021-02-14 | discomfort, dizziness, shortness of breath |
Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pal...
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Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 28 | 2021-02-16 | headache |
stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day th...
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stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day three of a coma on life support from a brain aneurysm; Mood swings; irate; Body aches; This is a spontaneous report from a Contactable Consumer, the patient. This 28-year-old non-pregnant female consumer (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 01Feb2021 as a single dose, for COVID-19 vaccination. Historical vaccination includes BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 1. The facility in which the second vaccine was administered was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. No Medical history reported ('No health issues, At all'). The patient has no known allergies. There were no concomitant medications. On an unspecified The Patient Experienced became irate. Mood swings. Body aches for couple days; On 07Feb2021 at 13:45, The patient experienced Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm (hospitalization, disability, life threatening), Treatment was given for the events of stroke, a thunder clap headache, limbs stiffened up, eyes crossed, lost speech, and brain aneurysm. The Adverse Event resulted in an Emergency Room Visit. Treatment was given for the events. 'Patient on Life support still'. The Clinical Outcome of the events Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm not recovered, while Mood Swings, Anger and Pain was unknown. Information on Lot has been requested.
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| 28 | 2021-02-21 | chills | Chills, body aches, sore arm |
| 28 | 2021-02-21 | dizziness | Mild-moderate dizziness for past 8 days |
| 28 | 2021-02-21 | chills, fatigue |
Supper fatigued; chills; This is a spontaneous report from a contactable Other healthcare profession...
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Supper fatigued; chills; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for herself. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at Left arm on 25Jan2021 18:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included allergies: Seafood. Concomitant medication included spironolactone. The patient's historic vaccine included first dose of BNT162B2 received on an unknown date for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. The patient experienced supper fatigued and chills on 26Jan2021 10:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on Jan2021. Information on lot number/batch number requested.
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| 28 | 2021-02-22 | fatigue | Fatigue and difficulty concentrating |
| 28 | 2021-02-22 | chills, fever, headache, fatigue |
Fever 101-102, body chills, body aches, generalized skin sensitivity, sore eyes, sore at injection s...
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Fever 101-102, body chills, body aches, generalized skin sensitivity, sore eyes, sore at injection site, headache, fatigue
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| 28 | 2021-02-22 | fatigue, fever, chills | Fever, chills, body ache, nausea, tiredness and fatigue for 36h, sore site of injection for 4 days |
| 28 | 2021-02-22 | headache, fever, fatigue, chills |
Fever, chills, tiredness, headache, body aches, sore lymph nodes, and nausea started approx 10 hours...
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Fever, chills, tiredness, headache, body aches, sore lymph nodes, and nausea started approx 10 hours after shot. Took ibuprofen and acetaminophen for the duration of the symptoms Sunday night and all day Monday. By the time I woke up Tuesday morning (approx 42 hours after shot) the only remaining symptom was sore lymph nodes and more tired than usual.
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| 28 | 2021-02-22 | fever, headache | Headache fever body ache |
| 28 | 2021-02-22 | dizziness |
Pt stated she felt lightheaded. Denies SOB, chest pain. She stated that she did eat breakfast this m...
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Pt stated she felt lightheaded. Denies SOB, chest pain. She stated that she did eat breakfast this morning and thought she may have been hungry and needed to eat lunch and she thought it may be indigestion. Gatorade and water given to pt and pt tolerated well. BP checked 120/80, HR 95. PT advised that if symptoms persist go to urgent care or to the closest PCP. PT verbalized understand and stated she felt fine to leave.
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| 28 | 2021-02-23 | chills, fever, cough |
Cough; Fever; Chills; Body aches; This is a spontaneous report from a contactable consumer. A 28-yea...
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Cough; Fever; Chills; Body aches; This is a spontaneous report from a contactable consumer. A 28-year-old female patient receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration at left arm from an unspecified date at a single dose for COVID-19 immunisation. The patient had no medical history. The patient is not pregnant. There were no concomitant medications. On an unspecified date, after first vaccine for two weeks, the patient had a cough, couple days of fever, chills and body aches. The outcome of the events was unknown. Information on the lot/ batch number has been requested.
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| 28 | 2021-02-23 | malaise, chills, dizziness, fatigue, shortness of breath |
Little shortness of breath; Dizzy; very tired; Chills; Stiff neck/ head and neck are very stiff; Fel...
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Little shortness of breath; Dizzy; very tired; Chills; Stiff neck/ head and neck are very stiff; Felt crummy; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 21Jan2021 at a single dose on the left arm to be prevented from COVID 19. The patient's medical history included COVID from 04Dec2020 and after that, on unspecified date, COVID test was negative. Concomitant medication was reported as none. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 on the right arm at 28- years of age to be prevented from COVID 19. On 21Jan2021, the patient had what everyone was talking about, the chills and stiff neck, she felt crummy, muscle aches, thought it was the normal. The next day (22Jan2021), she had a little shortness of breath, she felt dizzy on and off and her head and neck are very stiff, and she is very tired. The outcome of the events stiff neck/ head and neck are very stiff, felt crummy, and dizzy was not recovered while the other events was unknown. Information about lot/batch number has been requested.
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| 28 | 2021-02-25 | fatigue, chills, headache, fever |
Fever; Chills; Muscle aches; Swollen PAINFUL lymph nodes left armpit; Swollen PAINFUL lymph nodes le...
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Fever; Chills; Muscle aches; Swollen PAINFUL lymph nodes left armpit; Swollen PAINFUL lymph nodes left armpit; tingling left wrist; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: el9261) via an unspecified route of administration on the left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included drospirenone, ethinylestradiol (NIKKI) for birth control. The patient previously received first dose of BNT162B2 on 04Jan2021 for COVID-19 immunization (lot number: ej1685, left arm, 02:00 PM). On 26Jan2021 04:00 AM, the patient experienced fever, chills, Muscle aches, swollen painful lymph nodes left armpit, tingling left wrist, headache, fatigue. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Post vaccination, the patient has been tested for COVID-19, nasal swab on 25Jan2021: pending result. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. The facility where the vaccine was administered was in a Public Health Clinic/Veterans Administration facility. Outcome of the events was not recovered.
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| 28 | 2021-02-25 | fever, fatigue, chills |
Fever; chills; body aches; fatigue; This is a spontaneous report received from a contactable nurse (...
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Fever; chills; body aches; fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown), intramuscular on the right arm, on 28Jan2021 07:30, at SINGLE DOSE for covid-19 immunisation, at the workplace clinic. Medical history included asthma, allergies and COVID-19 (prior to vaccination). The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 28Jan2021 at 20:00, the patient experienced fever, chills, body aches and fatigue. The patient was not tested for COVID-19 since the vaccination. No treatment was received for the events. The outcome of the events was recovering. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
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| 28 | 2021-02-28 | headache, body temperature increased |
soreness at the injection site; Headache; elevated temperature (100.2 F); This is a spontaneous repo...
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soreness at the injection site; Headache; elevated temperature (100.2 F); This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration in left arm on 26Jan2021 08:30 at a single dose for covid-19 immunization. Medical history was reported as none. There was no other vaccine administered to the patient in four weeks. No known allergies. Patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. On 27Jan2021 at 07:00, patient experienced soreness at the injection site, headache and elevated temperature (100.2 F). Outcome of the events was unknown. Patient was given the vaccine in a workplace clinic. The patient has not tested with Covid since vaccination. Information about Batch/Lot number has been requested.
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| 28 | 2021-03-01 | chills, headache, throat pain |
significant lymph node swelling; body aches; unable to walk/stand; unable to walk/stand; chills; hea...
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significant lymph node swelling; body aches; unable to walk/stand; unable to walk/stand; chills; headache; sore throat; This is a spontaneous report from a non-contactable nurse. A 28-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 21Jan2021 at single dose for COVID-19 immunisation. Medical history included asthma, fibromyalgia, anxiety, depression and known allergies: penicillin. Concomitant medication included escitalopram oxalate (LEXAPRO), loratadine (CLARITIN [LORATADINE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). The patient previously took first dose of BNT162B2 on 02Jan2021 on the left arm. The patient experienced significant lymph node swelling, body aches, unable to walk/stand, chills, headache, sore throat on 21Jan2021.The patient received no treatment. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 28 | 2021-03-02 | fatigue |
Nauseousness; fatigue; diarrhea; This is a spontaneous report from a contactable consumer reported f...
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Nauseousness; fatigue; diarrhea; This is a spontaneous report from a contactable consumer reported for herself. A 28-year-old female patient (non-pregnant) received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number and expiry date were unknown), via an unspecified route of administration on the right arm on 31Jan2021 17:30 at a single dose for COVID-19 immunization. The patient has no other medical history. The patient has no known allergies to medications, food, or other products. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Feb2021 at 08:00, the patient experienced nauseousness, fatigue, and diarrhea. No treatment was received for the reported adverse events. The outcome of the events was unknown. The case has been considered non-serious. Information on the lot number has been requested.
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| 28 | 2021-03-02 | fatigue, chills, fever |
Significant swelling in left axillary lymph node; fever up to 102.7 F/low grade temp in low-mid 100s...
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Significant swelling in left axillary lymph node; fever up to 102.7 F/low grade temp in low-mid 100s; Severe chills; fatigue; Moderate muscle aches; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date unknown) in the hospital, via an unspecified route of administration on 28Jan2021 at 15:00 on the left arm at a single dose for COVID-19 immunization. Medical history included allergies to penicillin and sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol, norgestimate (ESTARYLLA) for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 (lot number: EL1284, expiry date unknown) on 06Jan2021 at 12:00 PM on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient experienced fever up to 102.7 F lasting from 05:00 on 29Jan2021 to 01:00 on 30Jan2021. The patient took 3 doses of 1000 mg Tylenol during this time period which would bring temp down to high 100s for an hour or two. After 01:00 on 30Jan2021, the patient had low grade temp in low-mid 100s until the afternoon. The patient also experienced severe chills, fatigue, moderate muscle aches on 29Jan2021 at 05:00. The patient had significant swelling in left axillary lymph node starting on the evening of 30Jan2021. The patient received treatment for the event fever but did not receive treatment for the other events. The outcome of the events was recovering. The events were reported as non-serious.
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| 28 | 2021-03-03 | headache |
back of her left shoulder is very painful; soreness; weakness in left arm; horrible pain injection s...
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back of her left shoulder is very painful; soreness; weakness in left arm; horrible pain injection site; redness at the injection site for 3 days after; Stomach pain; Nausea; Headache; redness in left arm; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), on the left arm, intramuscularly on 25Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history included ongoing seasonal allergy diagnosed a couple of years ago, ongoing food allergy she has had allergies to tree nuts, peanuts, shellfish, and sesame seeds her whole life. Concomitant medications include an unspecified product. The patient previously received the first dose of BNT162B2 on 04Jan2021 at around 12:30-13:00, intramuscular injection in left arm Lot number: EL1284 for COVID-19 immunization and experienced soreness. The patient also reported to have received a flu shot on an unspecified date in 2019 and had soreness. The patient reported to have received the second dose Monday, 25Jan2021 at 14:00 and had redness in her arm which recovered completely on Thursday 28Jan2021. On Tuesday night, 26Jan2021, the patient was sick with stomach pain, nausea, and a bad headache that went away by Wednesday, 27Jan2021. She was less sore on Wednesday, 27Jan2021, and she worked out, she did yoga, she got horrible pain at the injection site which started on 28Jan2021, Thursday morning in the middle of the night and stopped by the end of the day. States it went away with pain medication. The pain is nothing like she experienced before. The vaccine site area has been a little sore. She did yoga again last night and the same thing happened, she got pain at the injection site that was horrible. Reports the back of her left shoulder is very painful, it is sharp pains that do not go away on unspecified date. Took some Tylenol for pain at the injection site and left shoulder, that didn't help, took Aleve, heat and ice and by the end of the day, patient was fine. Just some soreness until middle of the night again, same reaction as before. Reports she had redness at the injection site 3 days after on 28Jan2021. She forgot to mention that she had weakness in her left arm that started 28Jan2021 and then she was fine and the weakness started again today. The outcome of the events redness in her arm was recovered on 28Jan2021, sick with stomach pain, nausea, and a bad headache was recovered on 27Jan2021, pain at the injection site, back of her left shoulder is very painful, weakness in her left arm was not recovered, while for the rest of the events was unknown. The patient was vaccinated in a hospital.
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| 28 | 2021-03-09 | chills, fever, dehydration |
After my vaccine I immediately experienced fever, body aches, chills, was dehydrated have a paralyze...
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After my vaccine I immediately experienced fever, body aches, chills, was dehydrated have a paralyzed vocal cord. I went to the hospital since I am pregnant to check on my baby and myself. I have not fully recovered from my vocal cord. At the hospital a rapid Covid test was performed along with a flu swab and lab work.
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| 28 | 2021-03-13 | dizziness, thirst, malaise, sweating, dehydration, weakness |
Symptoms: Fainting, Unconciouness (repeatedly), Profusive Sweating, Low Blood Pressure (60 over unkn...
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Symptoms: Fainting, Unconciouness (repeatedly), Profusive Sweating, Low Blood Pressure (60 over unknown number), Nausea, Dizziness, Unable to stabilize quickly, not able to get an IV, extreme thirst Signs: Immediately felt unwell within 5 minutes of the vaccine. Time Course: Injection (1st dose - Pfizer) at 4:00pm. Adverse Reaction at 4:05/4:10 (est.) Released at 5:00pm (est.) Description of Incident: On March 8th, at 4:00 pm, I received my first dose of the covid vaccine. Within 5 to 7 minutes, I felt unwell while sitting in the waiting area. I walked towards a worker to inform them that I was feeling unwell and that I was going to pass out. I became unresponsive and laid on the ground. My husband was with me at the time. I was unconscious for a bit and when I regained consciousness, my legs were being raised. I regained consciousness and was able to recall my name, DOB, and address. After I was done recalling my information, I began to lose consciousness again. They brought a wheelchair and took me to the medical room. As I moved from the wheelchair to the bed, I began to lose consciousness again. They told me to lay down. I overheard a woman ask my husband if I had diabetes or heart problems. He answered ?No.?. She explained to him that my body did not know how to accept the vaccine and was trying to regulate back to normal. She explained that my body was going through ?homeostasis? (?). While I laid on the bed, some workers took my blood pressure and tried to start an IV. One of them made a comment and said I was extremely dehydrated. This was odd to hear because I normally drink 3 to 4 liters of water daily. During this entire medical event, I felt the water pushing out through my pores. I was drenched in sweat. He tried to start an IV on my left arm and was unsuccessful. He tried to start an IV on my right hand, which was also unsuccessful. He stated they were unable to start IV liquids because my veins kept popping/collapsing. My blood pressure was reading 60. They checked it again, still at 60. I laid in the bed and basically waited it out. After a few minutes, they checked my blood pressure at it was at 120. They said that was good and I was good to go. No report was given to me nor my husband about the event that occurred. Even after they agreed to let me use a wheelchair (due to feeling weak), one was not provided to me. They basically stated that I was ?good to go?, after doing a series of hand squeezes and walking a few steps upright. I am currently trying to obtain a copy of the report I saw the gentleman fill out at the time. I was given Zofran to help with my nausea, it was placed under my tongue. After going home, I felt weak, tired and somewhat lightheaded. My husband drove me home and I got some rest. I set an appointment with my doctor on Friday March 12th to determine what happened to me during my vaccine and to record the incident. After describing the incident, she determined that it was anaphylaxis. She recommended for me not to get my second dose due to the anaphylactic shock I experienced with the first dose. She was shocked to learn that they did not transport me to the hospital or provided an Epi Pen injection. When asked why I didn?t drive myself to the hospital, I let her know that they told me I was ?good?. They did not explain what had occurred to me, no mention of anaphylaxis was explained. I was not aware that is what had occurred. The incident occurred from 4:00pm (injection time) to 5:00pm (left location).
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| 28 | 2021-03-18 | shortness of breath, cough |
tachycardia HR 135; shortness of breath; Mild Angioedema (local throat and tongue); Hoarse voice; Bi...
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tachycardia HR 135; shortness of breath; Mild Angioedema (local throat and tongue); Hoarse voice; Bilateral wheeze/ bronchospasm; Upper airway swelling; Tachypnoea: RR28; Sensation of throat closure; Irregular heart arrhythmia; Dry cough; This is a spontaneous report from a contactable other hcp (patient). A 28-years-old female patient receive dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3249, intramuscular left deltoid on 08Jan2021 07:35 at the age of 28 years as a single dose for covid-19 immunisation. Medical history included asthma from 04Apr2005 to an unknown date, obesity from an unknown date, seasonal allergy from 20Dec2007 to an unknown date , food allergy from 20Dec2007 (allergic to walnuts, peanuts, hazelnuts, palm oil) to an unknown date. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), docusate sodium (COLACE), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), iron (IRON), calcium (CALCIUM) , diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), on 08Jan2021 07:05 and acetaminophen on 08Jan2021 07:05 for antipyretic prophylaxis. The patient previously took sunflower seed oil base and experienced hypersensitivity. The patient carries EPI pen but never used, received allergy shot for 6 years only uses drug allergy season. Historical vaccine dose 1 of BNT162B2 for covid-19 immunisation on 18Dec2020, Left deltoid, intramuscular, Batch/lot number: EJ1685 at 08:45 am at age 27 years. The patient experienced mild angioedema (local throat and tongue) considered medically significant on 08Jan2021 08:00 with outcome of recovered 14:30 , hoarse voice on 08Jan2021 with outcome of unknown , shortness of breath on 08Jan2021 09:05 with outcome of recovered , tachycardia HR 135 on 08Jan2021 09:07 with outcome of recovered , bilateral wheeze/ bronchospasm on 08Jan2021 with outcome of unknown , upper airway swelling on 08Jan2021 with outcome of unknown , tachypnoea: RR28 on 08Jan2021 with outcome of unknown , dry cough on 08Jan2021 with outcome of unknown , sensation of throat closure on 08Jan2021 with outcome of unknown , irregular heart arrhythmia on 08Jan2021 with outcome of unknown and "Vacematter 08:45". Lab data all reported on 08Jan2021 included heart rate: 135 and 130, oxygen saturation: 98 %, respiratory rate increased 28. Therapeutic measures were taken as a result of mild angioedema, hoarse voice, shortness of breath, tachycardia HR 135, bilateral wheeze/ bronchospasm, upper airway swelling, tachypnoea: RR28, dry cough, sensation of throat closure, and irregular heart arrhythmia. The patient took Benadryl 50mg at 09:10 and experienced irregular heart arrhythmia.
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| 29 | 2020-12-31 | fatigue, headache | Fatigue, joint pain, muscle aches, stabbing headaches, redness and swelling at injection site. |
| 29 | 2020-12-31 | migraine, chills |
Immediate tingling to face, then on 12/23 migraines and smell adversions, 12/24 chills body aches an...
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Immediate tingling to face, then on 12/23 migraines and smell adversions, 12/24 chills body aches and skin burned, 12/25 no taste or smell with chills body aches diarrhea skin burned and brain fog, 12/26 positive rapid covid test and symptoms continue
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| 29 | 2020-12-31 | shortness of breath, sweating |
Intermittent runs of tachycardia accompanied with dyspnea and diaphoresis. Symptoms began approximat...
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Intermittent runs of tachycardia accompanied with dyspnea and diaphoresis. Symptoms began approximately 6 hours after receiving vaccine and has persisted.
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| 29 | 2020-12-31 | fever, headache |
Tuesday: headache and sore arm came around evening time then at night a fever of 102 kicked in. Wedn...
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Tuesday: headache and sore arm came around evening time then at night a fever of 102 kicked in. Wednesday: 102-101 fever took only ibuprofen Thursday: called doctor fever 99-101. Tyenelol and antibiotics and immune boosters Friday: doctor oncall told me to continue meds and she will call me back on Saturday. Fever still 99-101 range.
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| 29 | 2020-12-31 | chills, body temperature increased | nausea, myalgia, chills, temp 100.5 |
| 29 | 2021-01-01 | dizziness |
Lightheaded for about 20 minutes post injection. Did not alert staff , waited it out. Onset of light...
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Lightheaded for about 20 minutes post injection. Did not alert staff , waited it out. Onset of lightheadedness was quick .
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| 29 | 2021-01-01 | malaise, headache, fatigue | Pfizer-BioNTech COVID-19 Vaccine EUA Site pain, nausea, fatigue, feeling unwell, headache |
| 29 | 2021-01-01 | headache |
States she started feeling a bit of a headache after leaving the observation area, and by the time s...
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States she started feeling a bit of a headache after leaving the observation area, and by the time she got to her office in the same center, she had light sensitivity. Has not taken any medications no known allergies. Headache described as pulsating located in the front of her head. States relief when eyes are closed.
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| 29 | 2021-01-02 | chills, fatigue, fever, throat pain |
12 hours after first dose, had extremely painful and swollen R lymph cervical node and fatigue. Cont...
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12 hours after first dose, had extremely painful and swollen R lymph cervical node and fatigue. Continued for three days. On 12/25 awoke with painful gums, fevers of 102.1, chills in addition to symptoms. 12/26 had sore throat and worsening sores on tongue. Went to urgent care that morning, was tested for Covid, strep, influenza, RSV. All negative. Had overwhelming fatigue. 12/27 worsening tongue sores and thrush, had another appointment where given nystatin. At this appointment was diagnosed with an immune over response to the COVID-19 vaccine. The thrush still was not improving and extremely painful. Was started on Fluconazole for 14 days after another appointment on 12/29. No history of thrush, have good oral hygiene and follow all recommendations to prevent thrush with my inhaler. I lost 12 pounds due to the thrush and the extreme discomfort. Fever went away 8 days after vaccine dose, still have lingering thrush symptoms and R lymph node slightly enlarged.
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| 29 | 2021-01-02 | fatigue |
Approximately 5 hours after administration, I developed severe pleuritic chest pain and tachycardia ...
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Approximately 5 hours after administration, I developed severe pleuritic chest pain and tachycardia that self resolved after about an hour. This was followed by about 2 days of fatigue and myalgias that interfered with my daily activities that also self resolved. Had a large tender reaction on my left bicep for about 5 days after the injection.
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| 29 | 2021-01-02 | dizziness | Throat tightness Hot Dizzy Nausea |
| 29 | 2021-01-03 | lethargy, headache, fever |
12/21 - Fever (101.5), lethargy, headaches 12/22 - lethargy and headaches 12/23 - lethargy and head...
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12/21 - Fever (101.5), lethargy, headaches 12/22 - lethargy and headaches 12/23 - lethargy and headaches
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| 29 | 2021-01-03 | headache, chills, fever |
About 12 hours post vaccination, I developed body aches and fever and chills which persisted for ano...
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About 12 hours post vaccination, I developed body aches and fever and chills which persisted for another 48 hours. I had taken Tylenol 1000mg q6 hours about 14 hours after the vaccine for until Saturday. 72 hours post vaccine, body aches and chills are gone, only intermittent headaches that come and go. As of 1/3, 4th day post vaccination I have a red bump under the injection site, it is not raised but it is red and warm to touch and it still hurts while moving my left arm.
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| 29 | 2021-01-03 | dizziness |
Experienced nausea and dizziness. Lost consciousness in elevator. Blood pressure and heart rate drop...
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Experienced nausea and dizziness. Lost consciousness in elevator. Blood pressure and heart rate dropped. Husband was present and took me to the ED, where I regained consciousness gradually. Received treatment.
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| 29 | 2021-01-03 | fever, fatigue, chills | Fever, body aches, chills, body aches and fatigue. |
| 29 | 2021-01-03 | headache, migraine |
developed a migraine; nausea; sensitivity to light and sound; sensitivity to light and sound; she de...
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developed a migraine; nausea; sensitivity to light and sound; sensitivity to light and sound; she developed significant loss of mental clarity (brain fog); On 18Dec in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the the touch. This lasted about a total of 36 hours and progressively improve; brain fog; retroorbital headache/intermittent mild tension type frontal headache; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received first dose BNT162B2 (lot number EH9899), via an unspecified route of administration on 17Dec2020 12:00 at 29 years old at single dose at Left arm for COVID-19 immunization. Medical history included Mirena IUD, personal and family history of retinal migraines (without headache). The concomitant medications were magnesium citrate, melatonin, ademetionine (SAME) and fish oil. On 18Dec2020 in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the touch. This lasted about a total of 36 hours and progressively improved. There was no swelling, redness, or other local symptoms. In the afternoon on 18Dec2020, she developed significant loss of mental clarity (brain fog) while at work. In the evening on 18Dec2020, developed mild retroorbital headache (this was actually the first headache of my life). All day 19Dec2020 and about half the day of 20Dec2020 developed a migraine (also the first of my life), experienced as retroorbital pounding headache, sensitivity to light and sound in 19Dec2020, nausea without vomiting in 19Dec2020, and loss of mental clarity. She had intermittent mild tension type frontal headache on 20Dec2020 PM with all other symptoms resolved, all symptoms resolved by 21Dec2020 AM. The patient used naproxen 440 mg and Tylenol 1000 mg on 19Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not Allergic to medications, food, or other products. The outcome of the events was recovered on 21Dec2020. The information on the batch number has been requested.; Sender's Comments: Based on information available, the reported loss of mental clarity together with other events was likely related to the first dose BNT162B2 due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 29 | 2021-01-04 | chills |
All of a sudden I did not have any taste or smell; All of a sudden I did not have any taste or smell...
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All of a sudden I did not have any taste or smell; All of a sudden I did not have any taste or smell; Tested positive; Tested positive; This is a spontaneous report from a contactable nurse reported for herself. A 29-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, batch/lot EH9899), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. Medical history included seasonal allergy. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient was taking a multivitamin a day. The patient experienced typical symptoms no taste, smell on 22Dec2020, Slight tingling, body aches, chills, all the other symptoms for Covid and now positive for Covid in Dec2020. Outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for Covid based on the known safety profile.
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| 29 | 2021-01-04 | fatigue |
I felt that maybe they administered it too high, like the muscle area of my deltoid, and then around...
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I felt that maybe they administered it too high, like the muscle area of my deltoid, and then around 10PM my shoulder started to hurt and then the next morning my pain level was 9/10 and it was unbearable. I was very fatigued and could not use my arm to work since the pain in the arm. I took some Ibuprofen and took a nap and then after that it got a little better, it still hurt but at least I could I use my arm. The next day it was fine.
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| 29 | 2021-01-04 | dizziness |
Mild nausea (dizziness, tightness in jaw, sour taste in mouth, stomach pain) 5-10 minutes after in...
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Mild nausea (dizziness, tightness in jaw, sour taste in mouth, stomach pain) 5-10 minutes after injection. Muscle soreness at injection site beginning in the evening.
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| 29 | 2021-01-04 | shortness of breath |
Started with numbness to the whole body, palpitation, Dyspnea, and increased heart rate. This began ...
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Started with numbness to the whole body, palpitation, Dyspnea, and increased heart rate. This began 20 minutes after the injection. Lasted about 25 minutes. After this episode subsided, I continued to have persistent Dyspnea, chest pain, palpitations and heart racing. Was unable to speak in full sentences, exercise. Walking short distances caused extreme SOB. These symptoms lasted about a week.
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| 29 | 2021-01-04 | dizziness |
Sudden onset of tachycardia and palpitations; Sudden onset of tachycardia and palpitations; tachypne...
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Sudden onset of tachycardia and palpitations; Sudden onset of tachycardia and palpitations; tachypnea without SOB; Sudden elevation of BP 178/100; Dizziness; Nausea; skin tingling; This is a spontaneous report from a contactable other healthcare professional, who is also the patient. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EJ1685), via an unspecified route of administration in the left arm on 30Dec2020 at 12:30 (at the age of 29-years-old) as a single dose for COVID-19 vaccination. Medical history included Psoriasis, psoriatic arthritis, exercise induced asthma (no inhalers or treatment for >10 years). The patient had known allergies to methotrexate and chlorhexidine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications received within 2 weeks of the vaccination included apremilast (OTEZLA) 30mg BID (twice a day), bupropion hydrochloride (WELLBUTRIN XL) 300 QD (once a day), and buspirone hydrochloride (BUSPAR) 5mg. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 30Dec2020 at 12:30 the patient experienced sudden onset of tachycardia and palpitations and tachypnea without SOB within 3-5 minutes of injection. The patient also had sudden elevation of BP 178/100, dizziness, nausea, and skin tingling. The patient's BP gradually came down over 60 minutes. The dizziness lasted about 50- 60 minutes. No medication or medical assistance required. The patient was able to drive home. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 27Dec2020, with Test: Nasal Swab and Result: Negative.
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| 29 | 2021-01-04 | dizziness, skin warm, throat pain, weakness, cold sweat |
Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness,...
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Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness, and verbalized feelings of being cold along with a very flushed appearance. Skin was slightly moist and very warm to touch. Complained she felt the same as when she was diagnosed with the coronavirus infection in March of 2020. Patient continued to experience ongoing weakness in all extremities, dizziness followed by complaints of some changes in her sense of the light with her eyes closed. Shortly thereafter patient began complaining of her heart "speeding" up. Medic arrived and transported patient to the local emergency room. On 1-2-2021 patient provided additional information including that later on the evening of the adverse event the arm where the injection was given became painful and itchy. Patient stated the pain and itching extended into Friday 1-1-2021 and then on into Saturday, 1-2-2021 she developed a sore throat, and some difficulty swallowing (described it as feeling something "stuck" in her throat) along with hoarseness. The patient also verbalized she remained weak, with a very sore arm and some small blisters which had formed on the same arm as where the injection had been given. A couple of the blisters the patient described where on the thumb of her hand as well her arm.
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| 29 | 2021-01-04 | headache, chills |
Woke up in the middle of the night with severe chills and body aches. Eventually my symptoms lessene...
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Woke up in the middle of the night with severe chills and body aches. Eventually my symptoms lessened throughout the day (I did use analgesics), but still had chills, some achiness, and a headache the day after I received my vaccine.
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| 29 | 2021-01-05 | fever, chills, sweating |
1/4/21 12 hr after vaccine fever of 101.3 bodyache and chills . On 01/05 Joint pain ,chest pain...
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1/4/21 12 hr after vaccine fever of 101.3 bodyache and chills . On 01/05 Joint pain ,chest pain hot sweat chills and diarrhea
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| 29 | 2021-01-05 | chills |
30 minutes after injection of vaccine, I developed tightness in my throat (not severe). This persist...
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30 minutes after injection of vaccine, I developed tightness in my throat (not severe). This persisted for approximately 1 hour. Later in the evening around 1830, I developed chills and body aches. When I woke up the next day, all symptoms were gone.
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| 29 | 2021-01-05 | chills |
Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned in...
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Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; This is a spontaneous report from a contactable health care professional nurse, the patient. A 29-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 29DEC2020 09:15 as a single dose for COVID-19 immunization. Medical history included depression from an unknown date and unknown if ongoing, and Covid-19 on '17th of this month ' and unknown if ongoing. The patient had no known allergies. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), spironolactone (SPIRONOLACTONE), desogestrel, ethinylestradiol (KARIVA). No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. On 29Dec2020 16:30, the patient experienced Arm pain that gradually turned into body pain, joint pain, chills. The pain was so extreme. Patient had Covid on the 17th of this month and was not told that you should wait 90 days after to get the vaccine. The patient reported her response was worse than the side effects of Covid. The events result in a Physician Office Visit The patient was treated for Arm pain that gradually turned into body pain, joint pain, chills with Heating pads, Ibuprofen (Manufacturer Unknown) and Tylenol alternated. The clinical outcome of arm pain that gradually turned into body pain, joint pain, chills was recovered. Information regarding lot number has been requested.
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| 29 | 2021-01-05 | chills, headache |
Experienced minor chills about 11 hours post vaccination (7:00pm) and took 1000mg acetaminophen and ...
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Experienced minor chills about 11 hours post vaccination (7:00pm) and took 1000mg acetaminophen and went to bed at 9:30pm. Woke at 11:30pm with uncontrollable chills, nausea, headache and muscle spasms (shaking). Took 1000mg acetaminophen and was able to get back to bed at 2:30am. Had a vivid/stressful dream ongoing off and on all night about completing a task I couldn?t understand, was irrational, and completion would lead to the symptoms subsiding. Woke back up at 4:00am with chills and shakes and a headache and took another dose of acetaminophen. Relaxed at 5:00am and got out of bed. Took 600mg ibuprofen for significantly sore injection site that feels very deep and even goes into the arm pit.
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| 29 | 2021-01-05 | fever, chills | FEVER, CHILLS, AND MUSCLE PAIN |
| 29 | 2021-01-05 | headache, fatigue |
Fatigue; Nausea; Headache; Abdominal pain; Muscle soreness (spot of injection, it is better now); Th...
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Fatigue; Nausea; Headache; Abdominal pain; Muscle soreness (spot of injection, it is better now); This is a spontaneous report from a contactable other healthcare professional, the patient. A 29-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0140), via an unspecified route of administration on 28Dec2020 at 04:00 PM (at the age of 29-years-old) as a single dose in the left arm for COVID-19 vaccination. The patient had no relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient's concomitant medications in the past two weeks included bupropion hydrochloride ER 200 mg and ritual vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020, the patient experienced fatigue, nausea, headache, abdominal pain and muscle soreness (spot of injection is better now). The patient did not receive any treatment for the events. The clinical outcome of fatigue, nausea, headache, abdominal pain and muscle soreness was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 29 | 2021-01-05 | chills, fever, headache |
Fever 100.2 chills,Headache, Joint body ache left armpit swelling dime size symptoms started 12...
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Fever 100.2 chills,Headache, Joint body ache left armpit swelling dime size symptoms started 12 hours later after vaccine
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| 29 | 2021-01-05 | fatigue, fever, runny nose, chills | Feverish Chills Fatigue Runny nose |
| 29 | 2021-01-05 | headache | I had a headache for just one day.. Three days after the vaccine |
| 29 | 2021-01-05 | fever |
I received the first dose and one week later I formed a rash on my lower legs and a fever. The docto...
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I received the first dose and one week later I formed a rash on my lower legs and a fever. The doctors suspect Erythema nodosum but the tests are still pending.
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| 29 | 2021-01-05 | headache, chills |
Myalgia, chills, headache starting 1/6/2021 at 6 am Local pain and swelling starting 2 hours post va...
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Myalgia, chills, headache starting 1/6/2021 at 6 am Local pain and swelling starting 2 hours post vaccine
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| 29 | 2021-01-05 | dizziness |
Tachycardia, palpitations, flushing, and dizziness 1-2 hours after the vaccination administration. H...
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Tachycardia, palpitations, flushing, and dizziness 1-2 hours after the vaccination administration. Has persisted since.
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| 29 | 2021-01-05 | throat irritation | hives tickle in throat 1 hour post vaccination |
| 29 | 2021-01-05 | shortness of breath |
palpitations; Shortness of breath; Heart rate was 160s; This is a spontaneous report from a contacta...
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palpitations; Shortness of breath; Heart rate was 160s; This is a spontaneous report from a contactable Physician. This 29-Year-old female physician reported that she received 1st dose of BNT162B2 on 30Dec2020 08:30 AM at right arm for COVID-19 immunisation. Medical history included allergies: Citrus and cinnamon- perioral contact dermatitis. Concomitant therapy included birth control- Mylan. The patient reported within 5 mins of vaccine administration, she experienced palpitations and shortness of breath. Heart rate was 160s on 30Dec2020. No rash or fever. Event onset time was reported as 30Dec2020 8:30. She needed to be taken to the emergency room. Treatment was received as Steroids epinephrine Benadryl. The outcome of the event was recovering. The events were reported as non-serious. Lot/Batch and Expiration date has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 29 | 2021-01-06 | throat pain |
5 hours after injection patient had sudden onset difficulty speaking, nausea and vomiting, and sore ...
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5 hours after injection patient had sudden onset difficulty speaking, nausea and vomiting, and sore throat
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| 29 | 2021-01-06 | fever, chills | Fever of 101, chills, body aches |
| 29 | 2021-01-06 | headache, fever |
Fever to 101.4F, headache, nuchal ridigity, tachycardia low 100s, nausea, muscle aches, extremely so...
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Fever to 101.4F, headache, nuchal ridigity, tachycardia low 100s, nausea, muscle aches, extremely sore arm with injection site.
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| 29 | 2021-01-06 | chills, fever | Fever, severe chills for around 4 hours |
| 29 | 2021-01-06 | chills, nasal congestion, headache |
Headache,Myalgia, chills, felt hot all over but temp normal, nasal congestion, injection site sorene...
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Headache,Myalgia, chills, felt hot all over but temp normal, nasal congestion, injection site soreness Narrative: 12/29 got vaccine. 12/30 feet and hands felt cold. then she felt hot all over. her temp was normal. Then she developed nasal congestion and a headache. Later in the evening she developed body aches and injection site soreness. She took tylenol. 12/31chills have resolved. She has ongoing body aches, feels hot, headache. She called in sick 12/31. Symptoms resolved as of Jan 2.
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| 29 | 2021-01-06 | skin warm |
I received the pfizer COVID vaccine Wednesday 12/16. I noted an erythematous raised warm painful con...
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I received the pfizer COVID vaccine Wednesday 12/16. I noted an erythematous raised warm painful confluent blanching rash on 12/18. So far I have not has SOB, fatigue, N/V - any other systemic sx.
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| 29 | 2021-01-06 | somnolence, dizziness, headache, migraine |
Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobi...
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Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobility/lessened neck pain but still limited mobility; Scalp tenderness and sensitivity; Significant migraines/debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness); Sharp pains in neck/Neck pain; Sharp pains in neck, ear, head pain (similar to an ear infection pain); head pain/sharp pains in lower head/covers whole head, pulsating, sharp pain/Increase in headaches but no longer centralized to back of head/ headaches induced by allergies; Nausea; Neck stiffness; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number was unknown, via an unspecified route of administration in the right arm on 22Dec2020 07:30 at a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received vaccine in Tuesday (22Dec2020). The following Sunday (27Dec2020) at 12:00, she had nausea and neck stiffness. On Monday (28Dec2020), she had sharp pains in neck, ear, head pain (similar to an ear infection pain), and nausea. She used teledmed appt and got antibiotics (unspecified). On Tuesday (29Dec2020), she had significant migraines, limited neck mobility, sharp pains in neck and lower head, scalp tenderness and sensitivity which felt like whiplash when she moved her head w/ her head feeling "swimmy". She tried to see urgent care but was to go to ER. On Wednesday (30Dec2020), there was lessened neck pain but still limited mobility, increased in headaches but no longer centralized to back of head. She went to ER and they said that she had headaches induced by allergies. She mentioned that she never had migraines or allergies in her life. They also reported no ear infection. She did complete CT Scan with no concerning results on 30Dec2020. On Thursday (31Dec2020) & Friday, she no longer has neck pain but with continued nausea, joint pain, debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness). The events were reported as non-serious. The treatment received for the adverse events included fluids, pain & nausea meds. The patient was not diagnosed with Covid prior to vaccination. She was tested for covid post vaccination on 30Dec2020 through a nasal swab with negative result. The outcome of the events neck stiffness, ear pain, scalp tenderness and sensitivity, and 'Headaches induced by allergies' was unknown; while neck pain was recovered on 31Dec2020. The outcome of the events 'significant migraines/debilitating migraines', nausea, limited neck mobility, head pain/Headache, joint pain, loss of balance, and increased drowsiness was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the event migraine cannot be excluded based on a compatible temporal relation between vaccination and onset of event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 29 | 2021-01-06 | migraine | Migraine started about 24 hours after getting the 2nd shot on 1/4 at 9:20 |
| 29 | 2021-01-06 | fever, headache, chills |
Onset of fever, chills, muscle aches/joint pain, headache 11 hours after injection. Fever, chills, a...
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Onset of fever, chills, muscle aches/joint pain, headache 11 hours after injection. Fever, chills, and severe muscle aches/joint pain lasted for about 24 hours. Milder muscle aches and headache lasted for about 36-48 hours.
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| 29 | 2021-01-06 | dizziness, discomfort |
Patient received vaccine @ 1910. Patient sat in recovery area. Pt reported to RN that she was feelin...
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Patient received vaccine @ 1910. Patient sat in recovery area. Pt reported to RN that she was feeling faint and a bit of heaviness. Assisted patient to the floor with head supported with jacket in supine position with feet elevated. Patient did not faint. Obtained vitals 1914 BP: 103/68, HR: 67., o2: 97%. Patient denies being pregnant, but states that she has started a diet. Pt states eating yogurt prior to receiving the vaccine. Continued to monitor patient, no change in status. 1920 BP 129/75, HR: 80, o2: 98%. Patient states feeling better, asked to sit up, still on the floor. 1930 BP: 119/77, HR: 71, o2: 98%. Offered patient apple juice, pt able to tolerate PO liquids. 1940 patient assisted to sit up in chair BP: 134/89, HR: 72, o2: 100%. Patient continued to remain stable with improvement, no feeling of faint or heaviness. 1950 patient transitioned to standing position BP: 118, HR: 75 , o2: 95%. Pt walked around clinic to see if she could tolerate walking. Pt states having to drive home, asked if a ride was available, pt stated no. Pt states feeling fine to drive home. Pt discharge @ 2000 in stable condition.
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| 29 | 2021-01-06 | headache, chills | Severe chills with shivering Sweating Severe back and neck pain Headache Nausea |
| 29 | 2021-01-06 | fatigue, headache, fever |
~3 hours after injection: soreness at injection site After waking up the next morning: 101F fever, f...
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~3 hours after injection: soreness at injection site After waking up the next morning: 101F fever, fatigue, muscle soreness, headache
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| 29 | 2021-01-07 | throat irritation |
25 minutes after injection numbness of throat and tingling/prickling at back of tongue. Another 10 m...
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25 minutes after injection numbness of throat and tingling/prickling at back of tongue. Another 10 minutes later entire tongue tingling/prickling. Another 5 minutes lips began tingling/prickling. Epi-pen administered by military staff present for vaccination. Taken to ER and received a dose of Benadryl and prednisone.
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| 29 | 2021-01-07 | throat pain |
29-year-old previously healthy female presenting today with difficulty sleeping, sore throat, and na...
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29-year-old previously healthy female presenting today with difficulty sleeping, sore throat, and nausea after receiving the second Pfizer COVID-19 vaccine around 10 AM. Patient says that after her first dose of the vaccine she had mild sore throat and hoarse voice that resolved spontaneously. She had her vaccine around 10, several hours later before coming to the emergency department between 2--230 she had the sudden onset of difficulty speaking with associated sore throat and nausea. She has had dry heaving but no large amounts of vomiting. She has not had stridor, wheezing, shortness of breath, syncope, or the development of a rash or hives. She has not had a reaction to her prior vaccines she does not have any other allergies in general. She has otherwise been well recently without infectious symptoms including fevers, chills, cough, and has not been exposed to Covid to her knowledge. Medications administered in ED included diphenhydramine 50 mg IV once, dexamethasone 10 mg IV once, famotidine 40 mg IV once, ondansetron 4 mg IV once. Had brief episode of shaking and R arm rigidity in the ED. Patient denies LOC during the episode, did not have a post ictal state, no tongue biting or episodes of incontinence. Given single event without LOC, less concern about episode being a seizure. Patient has had no further episodes of shaking since admission. CT brain was wnl, no FNDs noted on exam.
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| 29 | 2021-01-07 | body temperature increased, headache |
6 hours post vaccine patient developed a bad headache; 12 hours post vaccine patient developed a tem...
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6 hours post vaccine patient developed a bad headache; 12 hours post vaccine patient developed a temperature of 102 degrees tympanic; 36 hours post vaccine patient developed hives on both feet. 48 hours post vaccine patient's headache and fever were gone and mild hives remained on the feet.
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| 29 | 2021-01-07 | headache, fatigue | Achy, tired, dull headache |
| 29 | 2021-01-07 | chills | Arm soreness, chills, achiness, lymphadenopathy |
| 29 | 2021-01-07 | fever, chills, headache |
Body aches; onset of fever /low grade fever; muscle aches; headache; chills about 11 hours after sho...
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Body aches; onset of fever /low grade fever; muscle aches; headache; chills about 11 hours after shot; patient received bnt162b2 first dose on 15Dec2020 16:00 and then second dose on 04Jan2021 14:15; This is a spontaneous report from a contactable other healthcare professional (patient) via Pfizer sales representative. A 29-year-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular first dose on 15Dec2020 16:00 at single dose (batch/lot #: EH9899), and then second dose on 04Jan2021 14:15 at single dose (batch/lot #: EK9231) for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy from an unknown date and unknown if ongoing. No known allergies to medications, food, or other products. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient experienced onset of fever /low grade fever, muscle aches, headache, chills about 11 hours after shot on 05Jan2021 01:00 am with outcome of recovering, no treatment for above events, and patient also experienced body aches on unspecified date with outcome of unknown. The adverse events result in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report is considered non-serious.
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| 29 | 2021-01-07 | headache, fatigue, headache, fatigue | Fatigue, headache, joint pain |
| 29 | 2021-01-07 | weakness, chills, fever | Fever, chills, weakness, body aches |
| 29 | 2021-01-07 | shortness of breath |
Had Throat and chest tightness, SOB, pruritis within 5 min of covid immunization. BP: 146/111, P 14...
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Had Throat and chest tightness, SOB, pruritis within 5 min of covid immunization. BP: 146/111, P 144; o2 99%, RR 16. She was given albuterol inhaler x 3, Epi-pen x 1, benadryl 25 mg with some iprovement. She was sent to ED. PMHx: tree nut allergy, Hashimoto's thyroiditis, hereditary hemochromatosis, PCOS; Taken to ED
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| 29 | 2021-01-07 | headache |
Headache and nausea with vomiting; Headache and nausea with vomiting; Headache and nausea with vomit...
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Headache and nausea with vomiting; Headache and nausea with vomiting; Headache and nausea with vomiting; This is a spontaneous report from a contactable Other HCP (patient). A 29-year-old female patient received the first dose of BNT162B2 (Lot number and expiry date not reported), intramuscular on 30Dec2020 07:15 at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. On 01Jan2021, the patient experienced headache and nausea with vomiting. No treatment received for all the events. The outcome of the events was recovered on an unspecified date. The following information on the lot/batch number has been requested.
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| 29 | 2021-01-07 | fatigue |
Mild nausea shortly after injection; Injection site soreness beginning in the afternoon of that day,...
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Mild nausea shortly after injection; Injection site soreness beginning in the afternoon of that day, continuing for days; Fatigue; This is a spontaneous report from a non-contactable other HCP. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included endometriosis. There were no concomitant medications. The patient experienced Mild nausea shortly after injection. Injection site soreness beginning in the afternoon of that day, continuing for days and Fatigue on 04Jan2021 12:45. Patient has not been diagnosed with COVID-19 prior to vaccination. Patient has not tested for coronavirus disease (COVID-19) since having the vaccine. Outcome of events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 29 | 2021-01-07 | chills, headache, fatigue | Onset Headache, Body Aches, Chills, Fatigue 10 hours after vaccine |
| 29 | 2021-01-07 | fatigue, chills, headache | Side effects included diffuse myalgias preventing sleep, fatigue, chills, mild headache. |
| 29 | 2021-01-07 | cold sweat, dizziness |
Tachycardia-160 for about 10-20 minutes about 10-15 after injection, HR 120-130 for about 1 hour, cl...
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Tachycardia-160 for about 10-20 minutes about 10-15 after injection, HR 120-130 for about 1 hour, clamminess, shaky, dizziness
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| 29 | 2021-01-07 | fatigue | Well at injection site, swollen arm around injection site, nausea, fatigue. Resolved on 01/08/2021 |
| 29 | 2021-01-07 | headache, fever, fatigue |
Woke up with fever day after receiving second vaccine, Tmax 102.2 with associated headache, fatigue ...
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Woke up with fever day after receiving second vaccine, Tmax 102.2 with associated headache, fatigue .
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| 29 | 2021-01-07 | dizziness | dizziness, body pain in arm chest and back, painful to touch. |
| 29 | 2021-01-07 | fever | fever 99.6 for 12 hours, soreness in upper arm and injection site |
| 29 | 2021-01-07 | headache, fever, chills | myalgias, fever, headache, left arm pain, chills |
| 29 | 2021-01-07 | dizziness |
red skin, itching, injection site pain, dizzines. Given 25mg PO benadryl, and then 25mg more benadry...
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red skin, itching, injection site pain, dizzines. Given 25mg PO benadryl, and then 25mg more benadryl after symptoms continued. After the second dose of benadryl, s/s subsided enough for the staff member to go home.
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| 29 | 2021-01-07 | fatigue, fever |
strange feeling in my throat; Shaking; I felt like a fever was coming on/temp of 102; fatigue; extre...
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strange feeling in my throat; Shaking; I felt like a fever was coming on/temp of 102; fatigue; extremely sore arm; This is a spontaneous report from a contactable nurse, who is also the patient. This 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) via an unspecified route of administration in the left arm on 17Dec2020 at 09:00 at single dose for COVID-19 immunisation. Vaccination facility type: workplace clinic. The patient did not receive other vaccines in four weeks. Relevant medical history included asthma, hypothyroidism, seasonal allergy, allergy to pine nuts and almonds and past drug history included allergy to levofloxacin (LEVAQUIN). Concomitant medications included ethinylestradiol/norethisterone acetate (LOESTRIN), levothyroxine sodium (SYNTHROID), fluticasone furoate (VERAMYST), levocetirizine dihydrochloride (XYZAL) and montelukast sodium (SINGULAIR). On 17Dec2020, within a few minutes of receiving the vaccine, the patient noticed a strange feeling in her throat. The patient stated that it was difficult to describe, but only lasted a minute or so. That night (17Dec2020), as she was getting ready for bed, she felt like a fever was coming on, but she checked her temperature and it was 97.6 (her normal temperature). She woke up around midnight shaking, with a temperature of 102. She took ibuprofen and it came down to 100.8 before she fell back asleep. In the morning, her temperature was down to 98.5 and she did not experience any additional fevers. The only other symptoms she experienced were fatigue and an extremely sore arm. These lasted about two days. The patient recovered from the events strange feeling in her throat on 17Dec2020 and she recovered from the fever on 18Dec2020; the patient recovered from the other events in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient was tested for COVID-19 with a nasal swab on 31Dec2020 which was negative.
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| 29 | 2021-01-08 | chills, sweating, fever |
Arm tingling, more prevalent in right arm, face tingling R>L. Tingling started at 0030 1/8, only las...
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Arm tingling, more prevalent in right arm, face tingling R>L. Tingling started at 0030 1/8, only lasted a few hours. Intense body aches, chills, low grade temp, started at 00:30 and ended by 1800. Still experiencing intermittent chills, flushing, and sweating.
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| 29 | 2021-01-08 | headache, chills, dizziness | Chills, dizzy, headache, injection site pain |
| 29 | 2021-01-08 | dizziness |
Dizziness, NauseaVomiting, Vertigo Narrative: Employee observed for 15 min in clinic after Vaccinat...
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Dizziness, NauseaVomiting, Vertigo Narrative: Employee observed for 15 min in clinic after Vaccination. Went back to work, as Clinical Pharmacist. Found she felt dizzy, vertigo, and nauseated. Unable to concentrate or focus on her work. She went home to recover
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| 29 | 2021-01-08 | fatigue, fever, chills |
Low grade fever, fatigue, chills, sore arm. Narrative: Low grade fever, sore arm, chills, and fatig...
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Low grade fever, fatigue, chills, sore arm. Narrative: Low grade fever, sore arm, chills, and fatigue developed after administration of covid vaccine. Resolved by 1/1/21.
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| 29 | 2021-01-08 | fatigue | Redness, swelling, warmth of injection site Fatigue |
| 29 | 2021-01-08 | malaise, chills |
Severe body aches, chills, mild nausea, malaise? I took 3 ibuprofen and 1 extra strength Tylenol to ...
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Severe body aches, chills, mild nausea, malaise? I took 3 ibuprofen and 1 extra strength Tylenol to alleviate symptoms, and went to sleep around 2pm, woke up for dinner and a shower and went back to sleep through the night
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| 29 | 2021-01-08 | fatigue, fever, chills, headache | Started with chills, then fevers, then headaches and extreme fatigue. |
| 29 | 2021-01-09 | chills, fatigue, headache |
After the second dose: arm pain at the site, chills, fatigue, body aches and headache for about 20 h...
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After the second dose: arm pain at the site, chills, fatigue, body aches and headache for about 20 hours starting 4 hours after shot. After first dose: injection site pain the next day
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| 29 | 2021-01-09 | headache, fatigue, fever, chills |
Around 4 am. Fever of 100.2 and chills that lasted about 12 hours. Headache that was unrelieved by m...
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Around 4 am. Fever of 100.2 and chills that lasted about 12 hours. Headache that was unrelieved by medication that lasted 24 hours. Fatigue that lasted 24 hours. Severe injection site pain that lasted 12 hours. Nausea that lasted about 12 hours.
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| 29 | 2021-01-09 | fever, chills |
Diffuse Myalgias, chills, low grade fever requiring Tylenol day after vaccination. Now resolved. ...
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Diffuse Myalgias, chills, low grade fever requiring Tylenol day after vaccination. Now resolved. Round, erythematous, flat, tender area on arm about 2 cm inferior to injection site. First noticed 3 days after vaccination.
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| 29 | 2021-01-09 | shortness of breath, dizziness |
Flushed face, light headedness, shortness of breath, and chest tightness 20 minutes after vaccinatio...
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Flushed face, light headedness, shortness of breath, and chest tightness 20 minutes after vaccination. Needed albuterol inhaler and benadryl to stop reaction. Redness swelling at injection site up to 1/2 dollar in size now, still increasing in size. Even after 3 days since shot
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| 29 | 2021-01-09 | malaise, fatigue |
Heart burn (severe) unrelieved by tums or pepcid x 3 nights and 3 days Fatigue Malaise Generalized ...
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Heart burn (severe) unrelieved by tums or pepcid x 3 nights and 3 days Fatigue Malaise Generalized muscle pain and fatigue Mild nausea
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| 29 | 2021-01-09 | dizziness | Lightheadedness, mental status changes (foggy) with difficulty focusing |
| 29 | 2021-01-09 | fatigue, headache |
Muscle spasms and pain (pins and needles sensation), extreme fatigue, headache, debilitating body ac...
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Muscle spasms and pain (pins and needles sensation), extreme fatigue, headache, debilitating body aches for 24+ hours, abdominal pain for 2 hours.
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| 29 | 2021-01-09 | headache |
Red, hot, swollen arm at and around injection site lasting greater than 48 hours post vaccine admini...
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Red, hot, swollen arm at and around injection site lasting greater than 48 hours post vaccine administration. Bone pain, lymph node swelling, headache for 36 hours post.
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| 29 | 2021-01-09 | chills, body temperature increased |
Twelve hours afterwards I had full-body convulsive-like shivers and ran a high temperature roughly 3...
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Twelve hours afterwards I had full-body convulsive-like shivers and ran a high temperature roughly 36 hours. The morning after I also had nausea and a few episodes of vomiting. 48 hours post-dose I had diarrhea
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| 29 | 2021-01-10 | fever, headache, fatigue |
About 15 minutes after vaccine, hr 155, fever 102, covered in hives, sick to her stomach and a poun...
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About 15 minutes after vaccine, hr 155, fever 102, covered in hives, sick to her stomach and a pounding headache. Has had headache since then and been extremely fatigue.
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| 29 | 2021-01-10 | chills, sweating, fatigue, body temperature increased |
Body aches, chills, sweats, fatigue, tachycardia, GI (gas, diarrhea), elevated temperature (Normal 9...
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Body aches, chills, sweats, fatigue, tachycardia, GI (gas, diarrhea), elevated temperature (Normal 97.1 -> 99.4) lasted for about 12 hours
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| 29 | 2021-01-10 | chills | Chills, cyanosis of fingernail, nausea |
| 29 | 2021-01-10 | fatigue, chills, headache | Chills, myalgia, headache, fatigue lasted 1 day. headache persisted to the next day |
| 29 | 2021-01-10 | fever | Fever, Body ache and injection site soreness. Took paracetamol - felt better. |
| 29 | 2021-01-10 | fatigue, chills, fever |
Fever, Tmax 101.2, lasting 48 hours. Chills; severe fatigue, still present (it has been over 48 hou...
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Fever, Tmax 101.2, lasting 48 hours. Chills; severe fatigue, still present (it has been over 48 hours). Abdominal pain, still present *for over 48 hours now). Nausea - starting after 24 hours of taking the vaccine and lasted 12 hours.
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| 29 | 2021-01-10 | fever, headache, lethargy |
Fever, lethargy, headache, muscle + joint ache, skin sensitivity, hair sensitivity, swollen lymph no...
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Fever, lethargy, headache, muscle + joint ache, skin sensitivity, hair sensitivity, swollen lymph nodes. 3 days out axillary lymph nodes still swollen with joint pain, all other symptoms subsided on day 2.
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| 29 | 2021-01-10 | chills, runny nose, malaise, influenza like illness, headache, cough |
First vaccine dose received 12/18/2020 @ 1844. Symptoms appeared 1 days later. Flu like symptoms wi...
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First vaccine dose received 12/18/2020 @ 1844. Symptoms appeared 1 days later. Flu like symptoms without fever, upset stomach, nausea, cough, chills, headache and general malaise. Improved with Theraflu and Tylenol .Symptoms worsened on 12/24/2020 around 1800. Runny nose, cough, headache, chills, body ache but still no fever.
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| 29 | 2021-01-10 | headache | Headache |
| 29 | 2021-01-10 | fatigue, headache, fever |
Intermittent headache starting one hour post and persisting through the next day. Fever, back ache, ...
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Intermittent headache starting one hour post and persisting through the next day. Fever, back ache, fatigue, injection site tenderness, and swollen lymph node to right neck, started morning after vaccine and resolved by second day after vaccine. Took Tylenol twice. Swollen lymph node under right arm, starting morning after vaccination; has reduced but remains present.
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| 29 | 2021-01-10 | fatigue, headache |
Red swollen lump that started same day of vaccine and is still there. Larger and hot to the touch. F...
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Red swollen lump that started same day of vaccine and is still there. Larger and hot to the touch. Fatigue and exhaustion. Body aches. Headache.
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| 29 | 2021-01-10 | fatigue, fever, chills | Severe fever (104.6), chills, nausea, fatigue, muscle soreness for 36 hours and ongoing. |
| 29 | 2021-01-10 | fatigue, malaise, headache, fever, chills |
Soreness at injection site began a few hours after administration. By the evening I began experienci...
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Soreness at injection site began a few hours after administration. By the evening I began experiencing headache and an overall malaise feeling. This progressed into chills to the point of shivering and feeling feverish. Overnight I developed another headache and felt very mildly nauseous in addition to feeling fever/chills. Overnight I took 3 OTC Advil, was bundled up under multiple blankets, and got lots of rest. The next day I felt much better, only some fatigue.
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| 29 | 2021-01-10 | shortness of breath |
Started as itching at the injection site approx 35 minutes after shot which led to generalized itchi...
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Started as itching at the injection site approx 35 minutes after shot which led to generalized itching on left arm, chest, and back when another colleague examined my back and noted hives. Became slightly short of breath and felt my heart was racing. Took 25 mg of oral Benadryl and told to go to ED. In ED heart rate was 126 bpm and BP WAS 136/99. Monitored in the ED for a few hours with no further interventions. Heart rate improved to 102 bpm and blood pressure to 129/82.
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| 29 | 2021-01-10 | dizziness |
Vitals : heart rate 140?s after reaction noted. After taken to ED for assessment- Temp 36.7, RR 16, ...
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Vitals : heart rate 140?s after reaction noted. After taken to ED for assessment- Temp 36.7, RR 16, Pulse 92-96, BP 115/68 and 104/66. SpO2 99-100% on room air Reaction: pale, lightheaded, said she felt like she ?was in a tunnel? after receiving vaccine, but felt better by the time she got to ED. Impression from provider: ?Acute Vasovagal response to injection?
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| 29 | 2021-01-10 | body temperature increased, chills, headache |
Woke up the neck day with a headache, chills, body ache, back pain, and sensitive skin. Got worse th...
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Woke up the neck day with a headache, chills, body ache, back pain, and sensitive skin. Got worse throughout the day. Temperature at 10:00 pm (14 hrs after injection) was 99.1 degrees Fahrenheit. Went to bed and woke up the next day feeling better. Slight sensitive skin, sore neck, and headache. Did not urinate for 9 hours.
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| 29 | 2021-01-10 | fever, chills, headache, fatigue |
fever, chills, body aches, fatigue, muscle soreness, headache, enlarged/swollen lymph nodes on left ...
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fever, chills, body aches, fatigue, muscle soreness, headache, enlarged/swollen lymph nodes on left side of neck
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| 29 | 2021-01-11 | headache, fever, dizziness, sweating, fatigue, chills |
1/8/21 - 15 minutes after second dose of COVID19 vaccine I had flushing (warm rash like) all over my...
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1/8/21 - 15 minutes after second dose of COVID19 vaccine I had flushing (warm rash like) all over my chest and neck that lasted for about an hour. No itching or hives. 1/9/21 at 3am my heart rate started to increase to about 110bpm while sleeping and continued till 4am. 1/9/21 at 4am my apple watch alerted me to my heart rate was above 120bpm while resting. This is when I realized I was sweating and felt like I had a fever. I drank water and went back to sleep. 1/9/21 5am heart rate was at 135. then 6am 148bpm. 7am around 161bpm. Kept trying to go back to sleep. 1/9/21 8am got up and took an adult benadryl tablet and drank plenty of water. Tried to relax to lower my heart rate. 1/9/21 9am took another adult benadryl tablet and was able to get my heart rate just below 120 while sitting. Then ate breakfast and went back to bed. If heart rate was not going to lower, I was planning on going to the ER. 1/9/21 10am till next day. Heart rate was then under 100bpm. I was then so tired that I slept all day and did not eat anything else. 1/10 I experienced severe body aches, chills and headache. This was all day. 1/11 I woke up feeling mildly nauseous for about 3 hours and then dizzy for about an hour. after that I just had a sore arm. 1/12 Had a mildly sore arm.
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| 29 | 2021-01-11 | chills, fatigue, fever |
12 hours following vaccination experienced fatigue, chills, body aches, and fever of 100.3 (t max) t...
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12 hours following vaccination experienced fatigue, chills, body aches, and fever of 100.3 (t max) that lasted 24 hours.
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| 29 | 2021-01-11 | fever, throat pain |
12/22 vaccination 12/24 48 hour after started to have nasal drip, sore throat. 12/26/2020 low grade ...
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12/22 vaccination 12/24 48 hour after started to have nasal drip, sore throat. 12/26/2020 low grade fever 12/28/2020 chest congestion; COVID 2nd test; negative sore throat, nasal drip x2 weeks
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| 29 | 2021-01-11 | respiratory tract congestion, fatigue | Congestion, nausea, fatigue, body aches |
| 29 | 2021-01-11 | cough, runny nose, respiratory tract congestion, throat pain, headache, chills | Cough, runny nose, sore throat, congestion, chills, HA- positive swab for Covid 12/28/20 |
| 29 | 2021-01-11 | weakness, cough, head discomfort, respiratory tract congestion | Deep cough, muscle soreness throughout entire body, weakness, congestion and pressure in head |
| 29 | 2021-01-11 | fever, cold sweat, headache |
During the first few hours following vaccination, I had soreness at the injection sight and a mild h...
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During the first few hours following vaccination, I had soreness at the injection sight and a mild headache. About 10hours later, I started to experience more severe symptoms including a fever of 101-102deg, chills/cold sweats, a moderate headache, and body aches. This continued throughout the night and into the next day. In addition, I began to experience a burning sensation in my chest, similar to heart burn. I have consistently been taking Tylenol and recently took Tums to aide with the heartburn feeling.
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| 29 | 2021-01-11 | malaise |
Feeling unwell, such as when one is coming down with flu/cold at the start of day and by the end of ...
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Feeling unwell, such as when one is coming down with flu/cold at the start of day and by the end of the day, her entire body ached like that caused by the flu; Feeling unwell, such as when one is coming down with flu/cold at the start of day and by the end of the day, her entire body ached like that caused by the flu; This is a spontaneous report from contactable other healthcare professional (patient herself). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration at the left arm on 03Jan2021, 10:00AM at a single dose for COVID-19 immunization. The patient had no medical history and had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not receive other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Jan2021, 07:00 AM, the patient experienced feeling unwell, such as when one is coming down with flu/cold at the start of day and by the end of the day (no time reported), her entire body ached like that caused by the flu. No treatment was received for the events. Outcome of the events at the time of last observation in Jan2021 was reported as recovered. The report was assessed as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect. Information on the batch/lot number has been requested.
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| 29 | 2021-01-11 | nasal congestion, headache | Headache, nausea, body aches, stuffy nose. Resolved. |
| 29 | 2021-01-11 | fatigue, headache |
Headache-Tylenol /onset 10 hours after Pain at injection site-onset 10 hours after Fatigue-onset 10...
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Headache-Tylenol /onset 10 hours after Pain at injection site-onset 10 hours after Fatigue-onset 10 hours after Left side Lymph node pain-onset morning after Joint pain-onset 10 hours after Body aches-onset 10 hours after
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| 29 | 2021-01-11 | headache, chills |
I started experiencing chills around 9:00 pm the same day I received the vaccine. I then began havin...
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I started experiencing chills around 9:00 pm the same day I received the vaccine. I then began having body aches, headache, and joint pain. I did not seek professional treatment but took Tylenol. It is now one day after receiving the vaccine and my symptoms are better but not yet completely resolved.
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| 29 | 2021-01-11 | fatigue, fever, headache | Low grade temp, tired, headache. Resolved. |
| 29 | 2021-01-11 | headache, fatigue | Nausea Body aches Fatigue Headache Injection site soreness |
| 29 | 2021-01-11 | fever |
Pain. It began as lower back pain at 1800 on 1/8/2021. By 0230 1/9/2021 pain progressed. Anterior sh...
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Pain. It began as lower back pain at 1800 on 1/8/2021. By 0230 1/9/2021 pain progressed. Anterior sharp bilateral pain noted in kidney region (below ribs). Lower back pain continued to worsen. Pain began to subside by 1000 1/9/2021. No pain by 1400 1/9/2021. Tylenol taken. Did not weaken the symptom. Additional signs and symptoms: Headache. Fever (range 99.2-101.6). Lasting 1/8/2021 (0230) through 1/9/2021 (2000). Tylenol taken for all signs and symptoms. every 8 hours. One pill.
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| 29 | 2021-01-11 | shortness of breath, dizziness |
Patient began to feel light headed, hot, and flushed. Over the next few minutes, the patient began ...
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Patient began to feel light headed, hot, and flushed. Over the next few minutes, the patient began to start breathing rapidly and become short of breath. Also, red blotches started to develop around her neck. Epi 0.3 mg IM given along with diphenhydramine 50 mg orally.
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| 29 | 2021-01-11 | headache, shortness of breath, dizziness, sweating, chills |
Received the vaccine 11:20am, experienced expected arm soreness and fatigue for the rest of the day....
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Received the vaccine 11:20am, experienced expected arm soreness and fatigue for the rest of the day. Went to sleep with no issues. Woke up at 2:00am uncontrollably shaking with chills/goosebumps, sweating with shortness of breath. Extreme headache and all over body soreness also at that time. This continued in waves for the next several hours. I finally slept for a short time and woke with continued headache and muscle/joint soreness. This was accompanied by dizziness, nausea and decreased appetite. This persisted throughout the entire next day following vaccination. The day after that was slightly better and the subsequent day I felt relatively back to normal. I checked for fever many times throughout the symptoms but was always afebrile.
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| 29 | 2021-01-11 | chills, headache, fever |
This is a spontaneous report from a contactable nurse. A 29-year-old female patient received bnt162b...
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This is a spontaneous report from a contactable nurse. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular from 17Dec2020 07:00 at single dose at right arm for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 17Dec2020 18:00, it was reported that the patient experienced fever, chills, aches, HA, stomach pains for first two nights, and only at night. Woke up, fine by morning. The events were assessed as non-serious. The patient did not receive treatment for the events. The outcome of the events was recovered. Information on the lot/batch number has been requested.
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| 29 | 2021-01-11 | headache, chills |
body feels like a furnace; shaking from her core; All main muscle groups sore/tense; All main muscle...
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body feels like a furnace; shaking from her core; All main muscle groups sore/tense; All main muscle groups sore/tense; mild chills; arm hurts so bad, like deep in her arm pit bad; Shooting headache; Vivid stressful dreams; Nauseous; This is a spontaneous report from a non-contactable pharmacist. A 29-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the right arm on 05Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 17Dec2020 16:45, at the right arm for COVID-19 immunization. On 05Jan2021, the patient experienced mild chills at 19:00 and took acetaminophen (TYLENOL) and went to bed, at 23:30, patient reported shaking from her core and all main muscle groups sore/tense. In addition, patient stated her arm hurts so bad, like deep in her arm pit bad, had shooting headache, vivid stressful dreams, & was nauseous on the same day of 05Jan2021. On 06Jan2021 04:00, the patient also stated her body feels like a furnace. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for it since the vaccination. The patient was recovering from the events. No follow up attempts are possible. No further information is expected.
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| 29 | 2021-01-11 | chills, fever |
chills; temp of 100.2; muscle aches; This is a spontaneous report from a contactable nurse (patient)...
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chills; temp of 100.2; muscle aches; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 05Jan2021 12:00 PM at single dose for covid-19 immunization. Medical history included none. Known allergies was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient experienced chills, temp of 100.2, and muscle aches on 06Jan2021 12: 00 AM. Treatment received for the adverse event was unknown. The outcome of the events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information on the lot/batch number has been requested.
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| 29 | 2021-01-11 | chills, headache, fatigue |
pain in the left armpit; a small protrusion in the area of the left collarbone which hurts to the to...
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pain in the left armpit; a small protrusion in the area of the left collarbone which hurts to the touch; a small protrusion in the area of the left collarbone which hurts to the touch; feeling headache; tiredness; chills; bnt162b2 first dose on 15Dec2020 at 14:30 and then second dose on 04Jan2021 at 15:30; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK4176), intramuscularly on 04Jan2021 at 15:30 on Arm Left at single dose for COVID-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. No concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within two weeks of vaccination. The patient previous took acetylsalicylic acid (ASPIRIN) and experienced allergy; first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 15Dec2020 at 14:30 on Arm Left at single dose for COVID-19 immunization and had pain in her left arm where it was administered the vaccine on 15Dec2020 at 15:00, the next day (16Dec2020) the area was red and inflamed, the redness and the inflammation lasted three days. The patient experienced hours after receiving the second dose of the vaccine she began feeling headache, tiredness and chills on 04Jan2021 at 21:00. The next day of the vaccine on 05Jan2021 she began feeling pain in the left armpit and she had a small protrusion in the area of the left collarbone which hurts to the touch. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
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| 29 | 2021-01-11 | nasopharyngitis, respiratory tract congestion |
she is pregnant as well; she reported to be diagnosed positive for COVID last 01Jan2021 after showin...
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she is pregnant as well; she reported to be diagnosed positive for COVID last 01Jan2021 after showing symptoms on 31Dec2020; she reported to be diagnosed positive for COVID last 01Jan2021 after showing symptoms on 31Dec2020/tested positive for COVID-19; This is spontaneous report from a contactable Other Health Professional (patient) via a Pfizer Sponsored Program. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1685), intramuscularly in right deltoid on 23Dec2020 14:30 at single dose for COVID-19 vaccination while pregnant. Medical history was none. Concomitant medication included ongoing ascorbic acid, betacarotene, calcium carbonate, colecalciferol, docosahexaenoic acid, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, vitamin b12 nos, zinc oxide (PRENATAL MULTIVITAMIN + DHA, Prenatal Multi + DHA), one soft gel, every morning as prenatal medication. The reporter was asking for recommendations for her in taking the second dose as she reported to be diagnosed positive for COVID last 01Jan2021 after showing symptoms on 31Dec2020. She received the first dose of the vaccine last 23Dec2020. She is asking if she should wait 90 days before taking the 2nd dose. Agent has a physical therapist on the phone. She had her first dose of the COVID vaccine on 23Dec2020. She started to show symptoms of COVID on 31Dec2020. She tested positive on 01Jan2020. Caller wants to know does she need to wait 90 days for the second dose. Caller wanted to add she is pregnant as well. She declined to include a healthcare professional for the report. The caller states she started to feel symptoms towards the end of the day on 31Dec2020. She clarifies she felt like she was having a cold coming on. She had some congestion. When probed for outcome, caller stated it had improved quite a bit. She had been improved but today, its kind of like she had a cold again, but that had improved. Vaccination Facility Type: Hospital. Vaccine Administered at Military Facility: No. Prior Vaccinations (within 4 weeks): None within 4 weeks. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Relevant Tests: None. Investigation Assessment: Yes. Is a sample of the product available to be returned, if requested (Y/N): Vaccine was administered in hospital. No AE required a visit to emergency room and physician office. The reporter stated her symptoms have been pretty mild. The patient underwent lab tests and procedures which included COVID Fast-acting (rapid) test: positive on 01Jan2021. Outcome of events was recovering.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 cannot be completely excluded
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| 29 | 2021-01-12 | chills, headache |
11 hours after administration, I experienced chills without objective fever, myalgias, localized inj...
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11 hours after administration, I experienced chills without objective fever, myalgias, localized injection site muscle soreness, headache.
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| 29 | 2021-01-12 | fever, chills, fatigue, headache |
After first dose: moderate right deltoid soreness only After second dose: fever, chills, nausea for ...
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After first dose: moderate right deltoid soreness only After second dose: fever, chills, nausea for about 36 hours from onset time listed, significant headache and fatigue for 48 hours from onset time listed
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| 29 | 2021-01-12 | fever, headache | Arm pain and neck pain, body aches, fever, headache |
| 29 | 2021-01-12 | fatigue, chills, headache |
At 3PM: fatigue. At 6PM: muscle aches, chills, headache that lasted for the next day. Muscle aches p...
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At 3PM: fatigue. At 6PM: muscle aches, chills, headache that lasted for the next day. Muscle aches persisted for 2 days.
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| 29 | 2021-01-12 | fever, headache | Body aches, joint pain, headache, low-grade fever. Symptoms lasted approximately 30 hours. |
| 29 | 2021-01-12 | chills, headache, fatigue, body temperature increased |
Chills, 01:00 am 102 temperate and head ache and chills. Next day had head ache and fatigue diar...
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Chills, 01:00 am 102 temperate and head ache and chills. Next day had head ache and fatigue diarrhea for 36 hours and got tested for 12/28/2020 Tested for COVID -19 was negative.
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| 29 | 2021-01-12 | fatigue |
Employee was vaccinated on 1/12 prior to start of shift. Called this am to report feeling extreme f...
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Employee was vaccinated on 1/12 prior to start of shift. Called this am to report feeling extreme fatigue and arm soreness. Stated she was not able to tie her hair or use arm without pain. Denies fever, body aches at this time.
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| 29 | 2021-01-12 | fatigue, shortness of breath, headache, sweating, throat pain, chills, cough |
Estimated due date: 03/17/2021 On the day of the vaccine during observation I had tingling in my mou...
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Estimated due date: 03/17/2021 On the day of the vaccine during observation I had tingling in my mouth, numbness in tongue and I just used my Benadryl and it eased the symptoms. But at night I started wheezing, had sweats and chills, did not check my temperature but I had pretty severe chills that night. In the morning I checked no fever, but still chills, severe cough and sore throat.. Headache and fatigue. All got worse more severe on Saturday and then I decided to go get tested for Covid on the Care Clinic. I had a known exposure to COVID before I got the vaccine around 01/04/21 - my husband who tested positive on the 6th) I tested positive. All symptoms continued (except the tingling on the mouth it stopped on the 8th) and I saw my OB-GYN on the 11th due to a low amniotic fluid - I had an ultrasound at the facility and was referred to MD and saw him on the 11th as well. Now I lost my sense of taste and smell. The chills have subsided a little bit and so the headache, but fatigue, congestion and cough are still there. I had increased intermittent shortness of breathe but could be the baby's position.
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| 29 | 2021-01-12 | chills, headache, fatigue |
Fatigue staring at 3pm. Muscle aches, chills, and headache starting at 6pm and lasting all through t...
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Fatigue staring at 3pm. Muscle aches, chills, and headache starting at 6pm and lasting all through the next day. Persistent muscle aches on the day after
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| 29 | 2021-01-12 | fever, fatigue, chills, headache |
Fever 101.0F; chills; headache; fatigue; arm soreness; second dose on 05Jan2021 15:30 /first dose on...
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Fever 101.0F; chills; headache; fatigue; arm soreness; second dose on 05Jan2021 15:30 /first dose on 18Dec2020; This is a spontaneous report from an other hcp. A 29-year-old female non-pregnant patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1284), via an unspecified route of administration at left arm on 05Jan2021 15:30 at single dose for COVID-19 immunization. Facility type vaccine was Hospital. No known allergies. No other medical history. Concomitant medication included ibuprofen, alprazolam, ergocalciferol (VIT D), clarithromycin (CLARITIN), cranberry. No other vaccine in four weeks. The patient received first dose (lot number= EK5730) via an unspecified route of administration at Left arm on 18Dec2020 at single dose for COVID-19 immunization. The patient experienced Fever 101.0F, chills, headache, fatigue, arm soreness on 05Jan2021 20:00. The patient underwent lab tests and procedures which included body temperature: 101.0 fahrenheit on 05Jan2021. No covid prior vaccination, Covid was test post vaccination via Nasal Swab on 22Dec2020 with result of negative. The events Fever 101.0F, chills, headache, fatigue, arm soreness were recovering. Treatment of acetaminophen received for the events Fever 101.0F, chills, headache, fatigue, arm soreness.
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| 29 | 2021-01-12 | fever, chills, headache, malaise | Fever of 101.5 Chills/body aches Muscle stiffness General malaise Nausea Headache |
| 29 | 2021-01-12 | headache, malaise, chills, fever |
Fever, Chills, Severe headache and unilateral left sided neck pain, severe malaise, fatigue, body ac...
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Fever, Chills, Severe headache and unilateral left sided neck pain, severe malaise, fatigue, body aches, diarrhea and abdominal cramps
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| 29 | 2021-01-12 | fever, shortness of breath, chills |
I am having chills since last night; Shortness and breathlessness last night; throat is super dry; d...
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I am having chills since last night; Shortness and breathlessness last night; throat is super dry; don't have too much pain in my left arm right where I got the vaccine; Left clavicle that is swollen and painful to touch; Left clavicle that is swollen and painful to touch; Little bit fever; This is a spontaneous report from a contactable consumer reported for herself. A 29-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (expiry date: Apr2021), via an unspecified route of administration in left arm on 05Jan2021 at single dose to get vaccinated to prevent COVID. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and hadn't taken Vitamins yesterday or day before. The patient got yesterday on 05Jan2021 the vaccine and thought that it was a side effect which she didn't have with the first vaccine. She had been having chills since last night 05Jan2021 and little bit of fever in Jan2021. She didn't have too much pain in her left arm right where she got the vaccine but her left clavicle that was swollen and painful to touch in Jan2021. The patient felt like she had a little bit of shortness and breathlessness last night 05Jan2021 but she was fine, her throat was super dry in Jan2021. For lot number, she stated "It is E. I am not sure what the next one is. It might be like a 21284." The patient had taken only pain killers she took two pain killers before she went to bed she took two pain killers when she woke in the middle of night and in morning. For Lab work, she just started feeling like between 12. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 29 | 2021-01-12 | dizziness, malaise, fever |
On 1/6/2021, Felt like she got hit by a train. Fever 102. Body aches from head to toe. Dizziness ...
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On 1/6/2021, Felt like she got hit by a train. Fever 102. Body aches from head to toe. Dizziness with intermittent slight rash. On 1/7/2021 she developed severe muscle pain, joint pain, fever, and intermittent lightheadedness and dizziness. She went to the emergency room on 1/10/2021 but no changes made in medications. She reports her BP was 207/111 and her pulse was 165/minute and still runs that high now. She had hypertension and tachycardia. About 1.5 years ago she had a history of hypertension and tachycardia. 1/12/2021 this person continued to have hypertension and tachycardia. Instructed to make an appointment to see her primary physician.
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| 29 | 2021-01-12 | dizziness, headache | Patient felt dizzy, and had a headache and required prolonged rest post second COVID vaccine |
| 29 | 2021-01-12 | headache, fatigue |
Several hours after vaccination, I developed left arm soreness, which persisted for about 36 hours. ...
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Several hours after vaccination, I developed left arm soreness, which persisted for about 36 hours. Arm soreness was quite severe on 1/8, as it was painful to even lift the left arm for much of the day. I also noted, about 5 hours after vaccination, that my jaw felt slightly tense, bilaterally. On Friday, 1/8, I also experienced headache for the entire day, and I was fatigued for much of the day. I noted clavicular lymph nodes as well. About 18-20 hours after vaccination, I developed soreness in my back, and about 24 hours after vaccination, I noted some myalgia in the left leg. These symptoms were responsive to acetaminophen. The headache, clavicular lymph nodes, arm soreness, and myalgias were resolved by the time I woke up on 1/9. Finally, I noted development of an axillary lymph node during the evening of 1/8, about 28 hours after vaccination. This axillary node persisted until Monday, 1/11.
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| 29 | 2021-01-12 | fatigue, fever, headache |
The vaccine was given at 12:20 pm 1/9/21 8:30 pm Diahrrea 9:30 pm Exhaustion, body aches, headahce 9...
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The vaccine was given at 12:20 pm 1/9/21 8:30 pm Diahrrea 9:30 pm Exhaustion, body aches, headahce 9:30 pm-7:30 am body aches/muscle aches/joint pain so severe unable to sleep without waking up every hour 7:30 am took Ibuprofen and slept until 3 pm, exhaustion, headache 1/11/21 fever of 100.1 and body aches, headache and exhaustion, took Ibuprofen 1/12/21 back to normal functioning no aches/pains/fever
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| 29 | 2021-01-12 | dizziness, fever, malaise |
This person stated she felt like she was hit by a train starting about 8pm on 1/6/2021. She stated ...
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This person stated she felt like she was hit by a train starting about 8pm on 1/6/2021. She stated she had a fever of 102. Her body ached all over from head to toe. She had dizziness with an intermittant rash. She did go to the emergency room on Sunday 1/10/2021 with hypertension and tachycardia. Her BP was running at around 207/111 and her pulse has stayed around 165 even through today on 1/12/2021. She did state about 1.5 years ago she experienced tachycardia and hypertension but not since. She did not get any new medications upon her visit to the emergency room. She was going to try to see her physician today if possible on 1/12/2021.
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| 29 | 2021-01-12 | chills, headache, fatigue |
Tossed and Turned had chills awoke at 01:00 am tempt check 102. head aches, diarrhea, fatigue . Fa...
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Tossed and Turned had chills awoke at 01:00 am tempt check 102. head aches, diarrhea, fatigue . Fatigue and head aches for 36 hours Tested for COVID -19 negative.
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| 29 | 2021-01-12 | weakness, headache, body temperature increased, fatigue |
Weakness, tiredness, increase in temperature, nausea, headache, joint pain, stomach ache, heartburn,...
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Weakness, tiredness, increase in temperature, nausea, headache, joint pain, stomach ache, heartburn, vaccination site soreness
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| 29 | 2021-01-12 | fever, headache |
fever (102.6F), nausea/vomiting, body aches, headache; worst at 18hrs after receiving 2nd dose, reso...
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fever (102.6F), nausea/vomiting, body aches, headache; worst at 18hrs after receiving 2nd dose, resolved roughly 24hrs after onset
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| 29 | 2021-01-12 | fatigue, malaise, fever, headache |
fever of 38C; severe fatigue and malaise; severe fatigue and malaise; mild headache; Pain in the inj...
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fever of 38C; severe fatigue and malaise; severe fatigue and malaise; mild headache; Pain in the injection site began within a few minutes and gradually increased reaching it's maximum around 8 hours after the dose.; Neck pain was also significant; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 05Jan2021 12:00 PM (Left arm) at single dose on arm for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 09:00 PM (Arm Right) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included asthma and generalized anxiety disorder (GAD). The concomitant drug was reported as Escitalopram. The patient experienced pain in the injection site began within a few minutes (05Jan2021 12:15 PM) and gradually increased reaching it's maximum around 8 hours after the dose. Neck pain was also significant (05Jan2021 12:15 PM). Fatigue, malaise and mild headache started around 10 hours (05Jan2021 22:00) following vaccine administration. Almost 24 hours following administration (06Jan2021 12:00) a fever of 38 C started and persisted for about 6-8 hours. It subsided but severe fatigue and malaise (that prevent me to do daily activities) are still persisting greater than 48 hours following administration. The outcome of severe fatigue and malaise was not recovered. The outcome of Headache, Pain in the injection site, Neck pain, fever of 38 C, was recovering. No treatment received for the adverse event. No COVID prior vaccination and no COVID tested post vaccination. Information on Lot/batch number has been requested.
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| 29 | 2021-01-12 | fever |
fever; body aches; This is a spontaneous report from a Pfizer sponsored program. A contactable consu...
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fever; body aches; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via unspecified route of administration, on 15Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included stress, cold sores, and birth control. Concomitant medications included valaciclovir hydrochloride (VALTREX) from 2009 and ongoing for cold sores, fluticasone propionate (FLONASE), and ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20) from 2006 and ongoing for birth control. The patient received the vaccine through work. The first time she got it, she had a fever on 16Dec2020 that lasted in 24 hours (until 17Dec2020). She also had body aches that lasted for 48 hours. Those were from the 16th to 18Dec2020. She received the first dose on the 15Dec2020. Then, the morning of the 16Dec2020, she noticed body aches. She didn't get a fever until later that afternoon. She got the vaccine because she works in a nursing home. She is an essential worker who is at high risk. The patient recovered from the fever on 17Dec2020 and recovered from body aches on 18Dec2020.
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| 29 | 2021-01-13 | chills, throat pain, cough, runny nose, nasal congestion |
1 hour after: local site pain, ache throughout same extremity 24 hours after: chills and overall ski...
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1 hour after: local site pain, ache throughout same extremity 24 hours after: chills and overall skin sensitivity 48 hours: respiratory symptoms- cough, sore throat, runny nose, congestion
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| 29 | 2021-01-13 | weakness, dizziness |
1 week history of significantly worsened (previously present "low back strain" lower back pain that ...
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1 week history of significantly worsened (previously present "low back strain" lower back pain that had become radicular to both LE and associated with progressively worsening bilateral LE weakness, paresthesias since COVID vaccination last week. see continuation for HPI and assessment/plan from office note 1/13/21 HPI from OV dated 1/13/21 She had presented initially in December 2020 for her annual physical, and we evaluated some low back pain that that time, felt to be a sprain/strain resulting from a fall in the shower earlier December which was aggravated significantly by lifting/transferring a patient at the SNF she works for as a nurse. Presentation at that time was rather benign, no imaging obtained, pt was placed on leave from work for 1 week to avoid the heavy lifting and likely aggravation of back pain, and rx including diclofenac and cyclobenzaprine. She did not FU in the office, but returned to work at SNF a week after I saw her for the back pain. She states she had improved enough to feel like she could go back to work but wasn't 100% without back pain yet. At no time was comp mentioned at the visit in December. She did tell her employer about the injury and was off of work for a week and was encouraged to seek comp. We were never notified. Yesterday 1/12 she followed up in the office for the back pain and was found to have much more severe pain, now radicular to both LE (pain intensity worse on right), with new neurologic impairment including objective weakness bilateral LE (R>L), sensation disturbance bilateral LE (R>L). Xray of lumbar spine obtained in clinic, this was essentially unremarkable, non-acute. Pt was sent for stat MRI of the lumbar spine. MRI last night revealed no findings to explain her severe symptoms - she has mild symmetric disc bulging at L5-S1 nd mild bilateral facet arthropathy with patent canal and foramina, and a mild nonspecific "STIR signal abnormality" within the soft tissues abutting the left lateral aspect of the L5 spinous processes felt to be small and nonspecific. I did discuss the case and the imaging with the radiologist and he feels this is unlikely to be the source of her back pain/radicular symptoms. No obvious signs of apparent discitis or any signficant soft tissue abnormality. Pt contacted last night with initial "normal" results of MRI as formal results were pending - hydrocodone was sent to her pharmacy for pain relief overnight. Pt received 60mg toradol in the office yesterday during her visit. Pt noted significant improvement in her back pain, bilateral leg pain about 30 minuts after that injection. She continued to have pain in the evening but went to sleep. She woke at 3am unable to roll over due to weakness and pain - her sister gave her a hydrocodone and she went back to sleep' she woke this morning feeling much better; today, she has less severe low back pain, less severe right lower leg radicular pain, NO pain radiating into the left LE, lessening of the weakness in her right LE, lessening of paresthesia reported in the right LE (now isolated just to the heel), resolution of the weakness in the left LE, resolution of the tingling of the left knee. Other than the toradol and one dose of hydrocodone, no other medications were given, no other treatments given since presentation yesterday. Upon further questioning, patient does reveal that she received the 1st of 2 COVID-19 vaccinations (pfizer) last week. She received the vaccination at work at nursing home on 1/7/21. She had some relatively quick onset nausea and dizziness within an hour of the injection, but that resolved. She recalls feeling like her low back pain, bilateral lower leg pain, leg weakness and paresthesias all intensified sometime either Wednesday 1/6/21 or 1/7/21, but more obviously worsened over the weekend 1/9 and 1/10. Along with the lower extremity symptoms, she does admit today that she experienced soreness in bilateral upper arms starting the day following the vaccine administration, with left arm/shoulder still feeling sore and tender to the touch now. She also developed some altered sensation of the right thumb and index fingers the day following vaccination (1/8/21) and this has been persistent/unchanged. She is right handed. No prior issues with right hand/fingers. Other than the altered sensation, she denies pain, swelling, or notable weakness. She is right handed, and really hasn't done much with her right hand over the past week since she hasn't been working. Patient denies having significant headache, fever, chills, diaphoresis, fatigue, rashes/injection site erythema since the covid vaccination. She was not told to sign up for or told about the V-safe program and hadn't thought to report her symptoms to work or think to be concerned regarding possible vaccine SE. Pt denies prior hx of low back pain, neurologic symptoms including weakness/paresthesias, previous allergy to or adverse reaction to vaccination or injectable medications. She has a history of latent TB(fully treated) but is otherwise in good health. After gathering much further detailed information/history today from patient, review of chart including the MRI results and xray results from yesterday, my prior OV note, and discussion with radiologist today regarding her MRI - I Discussed with patient and her sister that I believe what is becoming more apparent to me now is that she is likely suffering from an adverse event associated with the COVID-19 vaccination she received on 1/7/21 through her workplace. I'm unable to define this for certain, but I suspect that she developed the progressive worsening of low back pain, development of radicular pain and bilateral LE weakness and paresthesias about 1-2 days following the vaccination administration. She has had notable and rather surprising improvement in both subjective and objective findings Today as compared to yesterday. Only intervention was toradol 60mg IM and one dose of hydrocodone, she had already been taking diclofenac or ibuprofen so I believe the only explanation for the improvement over the past 24 hours is the fact that she is gradually having resolution of the temporary paraparesis, neuralgia, paresthesia brought on by the recent COVID-19 vaccination. I believe she truly had injury to the low back in December, initial injury at home but had improvmenet and then significant worsening/exacerbation when transferring a resident at work. Her presentation following that was consistent with a strain/sprain of the lumbar spine. This was treated appropriately with rest, activity modification, stretching, NSAID, and muscle relaxers. She returned to work w/o restriction likely earlier than she should have but I believe the covid vaccination is likely what caused her condition to so significantly decline; Its also possible that her physically demanding job requiring lifting/transferring/standing for prolonged periods of time on top of an only partially resolved low back strain had aggravated her low back condition. plan from OV dated 1/13/21 Given the improvement since yesterday, I recommended obtaining some labs looking for any sign of alternative explanation including infectious etiology or autoimmune/inflammatory condition, however will hold on further imaging as would be the plan, specifically EMG of the bilateral LEs. Explained to patient that I'm hopeful with continued rest and time, her symptoms (weakness, tingling/numbness, radicular back pain) will completely resolve. She may need some eventual PT for the disc bulge in the lumbar spine and lumbar strain that is likely still lingering. Will contact pt with any change in care plan based on the laboratory findings. I would like to closely follow her, and make sure her symptoms continue to slowly improve /resolve. If at any point she develops worsening symptoms again or any new neurologic signs/symptoms (and we discussed what emergency signs/symptoms would be) then she needs to be in touch with me right away. I will work on reporting this suspected adverse covid vaccine reaction to VAERS / possibly also CDC and see if they have any additional input/suggestions for monitoring/treatment. For pain control, pt may continue with the diclofenac OR ibuprofen, and the hydrococone/APAP as needed for breakthrough severe pain uncontrolled with the NSAID. I have advised pt to remain off of work at this time, resting at home avoiding lots of physical activity as she continues to heal. Suspect will have her follow up in clinic sometime next week for repeat evaluation/examination depending on VAERS/CDC recommendations and of course the lab results and any updated condition reports from the patient in the interim. Will want to make sure she has full resolution of the paresis and adequate resolution of her back pain/radicular pain prior to returning to work, even in a limited capacity. I am informed today that there is light duty available and will keep that in mind. Pt to be contacted regarding follow up. Encouraged to call with questions/concerns/updates. Pt was very thankful for the care.
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| 29 | 2021-01-13 | dizziness |
1238 staff member received vaccine, 1245: staff member reported feeling dizzy with vital signs taken...
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1238 staff member received vaccine, 1245: staff member reported feeling dizzy with vital signs taken: bp-155/97, P-77, O2@98%, R-16. Reported to pharmacist who adm. vaccine, staff member was given water and told to stick around an additional 15 min for monitoring. 1257: Pharmacist rechecks staff member and notices Blotchy redness to her neck and chest, does not report signs of itchiness but does feel warm, window opened nearby, cont. to monitor staff member, 1320: staff member reports she feels better. 1309: staff member rechecked by pharmacist,
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| 29 | 2021-01-13 | fever, chills, fatigue, headache |
About 12 hours after receiving the second dose of the COVID 19 Vaccine (1/9/21), I had sudden onset ...
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About 12 hours after receiving the second dose of the COVID 19 Vaccine (1/9/21), I had sudden onset of fever, chills, nausea, headache, and fatigue. The fever, chills, nausea lasted for about 36 hours from onset, and notable headache and fatigue lasted for about 2.5- 3 days after onset of symptoms. They resolved by the evening of 1/12/2021.
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| 29 | 2021-01-13 | fatigue, chills, fever |
Chills, Fatigue, left arm pain and fever of 100.3. Treatment include Tylenol with no improvement at...
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Chills, Fatigue, left arm pain and fever of 100.3. Treatment include Tylenol with no improvement at this time.
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| 29 | 2021-01-13 | headache, chills | Chills, headache, diarrhea, nausea |
| 29 | 2021-01-13 | headache, body temperature increased |
Date of symptom onset ? 1/14/21? Symptoms - ? EE reports she woke up at 06:30 with body aches, mild...
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Date of symptom onset ? 1/14/21? Symptoms - ? EE reports she woke up at 06:30 with body aches, mild headache and back pain. EE reports she took 400 mg motrin at 0700 and came to work. EE reports around 09:00 worsening HA and nausea. EE took her temp (99.1) and took 1000 mg Tylenol. EE advised by manager to call vaccine support line for recommendations. Last day of work and shift - ? EE currently at work Home remedies? ? see ?symptoms? for narrative Any improvement? - mild Recommendation? EE encouraged to continue to monitor her symptoms and to contact the vaccine support line for further questions or concerns. EE denies covid-19 exposure without proper PPE and denies travel. EE does not meet criteria to be COVID tested at this time. EE educated to continue to manage per TCH Illness in the Workplace Policy and to notify manager if she needs to leave work today. EE verbalized back understanding and denied further questions at this time.
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| 29 | 2021-01-13 | fever, headache |
Fever (T-max 100.4); headache; body aches; This is a spontaneous report from a contactable health ca...
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Fever (T-max 100.4); headache; body aches; This is a spontaneous report from a contactable health care professional, the patient. A 29-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284) in the left arm on 07Jan2021 as a single dose, for COVID-19 vaccination. The vaccine was administered at a Hospital. Medical history included Stiff-man syndrome, polycystic ovarian syndrome and known allergies to soy, sesame, and walnuts. Concomitant medication included tramadol (TRAMADOL), gabapentin (GABAPENTIN), methocarbamol (ROBAXIN), dienogest, estradiol valerate (NATAZIA), insulin (INSULIN). The patient previously experienced drug hypersensitivity to Penicillin, Neosporin, and Levaquin. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), in the left arm on 17Dec2020 11:AM. No other vaccines were given within 4 weeks except the first dose of BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 07Jan2021 17:30, the patient experienced fever (t-max 100.4), headache and body aches. Lab data include body temperature: t-max 100.4 on 07Jan2021. No treatment was given for the events. The clinical outcome of the events fever (t-max 100.4), headache and body aches was recovering.
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| 29 | 2021-01-13 | shortness of breath, headache, fever, chills |
I had a fever and chills at night and also a headache, I felt nauseous, vomiting and difficulty brea...
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I had a fever and chills at night and also a headache, I felt nauseous, vomiting and difficulty breathing. I could not sleep that night after I received my vaccine. I decided not to go the ER and slept it off I woke up much better next morning. I saw a Doctor a couple of days later because I had shortness of breathing and a high heart rate while I was at work. He just told me to take it slowly at work. No meds. I then started working part-time for some weeks and am being introduced again now to my regular scheduled.
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| 29 | 2021-01-13 | sweating, headache, fatigue, dehydration, weakness |
I received my second dose of the vaccine at 03:00pm on 1/12/21. I noticed around 06:00pm that I star...
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I received my second dose of the vaccine at 03:00pm on 1/12/21. I noticed around 06:00pm that I started feeling a little tired and some pain around the injection site. I had anticipated this as I felt similar symptoms from the first dose of the vaccine. I took a nap and woke up around 09:00pm feeling some of the worst body aches I had felt in a long time. My arm that I received my vaccine in was painful and warm to the touch. I felt dehydrated as well so I drank a pedialyte, took OTC Tylenol extra strength, and laid down again. Around 07:00am on 1/13/21, I still felt achy, sweaty, and felt pain in the arm that I recieved the vaccine in. I went into my bathroom, and noticed two small red and raised areas around the injection site. I took pictures of the site, and continued to closely monitor through out the day. I ended up calling in sick to work on 1/13/21. It is now around 12:00pm on 1/14/21, and I woke up with a pounding headache, muscle aches, dehydration, nausea, and low energy. I feel like I am hungover or have the flu, and am planning on calling in sick to work again. I reported my symptoms to my staffing department at my workplace on 1/13/21 and wanted to file a report here as well.
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| 29 | 2021-01-13 | fatigue, chills, fever |
Nausea and vomiting about 12 hours after injection. Followed by fevers, body aches, sinus headache, ...
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Nausea and vomiting about 12 hours after injection. Followed by fevers, body aches, sinus headache, and fatigue for about 30 hours. Post 3 days after injection all finger tips have been cold, red, numbness, and tingling. Now post 5 days after injection finger tips have improved but still red, cold and difficult to get warm.
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| 29 | 2021-01-13 | chills |
On 1/14/2021 at 0630am, I noticed my armpits were bright red, with no raised rash, and warm to the t...
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On 1/14/2021 at 0630am, I noticed my armpits were bright red, with no raised rash, and warm to the touch. There is a sensation of warmth and feeling "full" in this area. At this time, no treatment has been taken as it is not uncomfortable. It is 1:45pm, and all symptoms are still present. The warmth sensation has slightly increased throughout the day. I have had bouts of chills throughout the day, but no fever or headache.
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| 29 | 2021-01-13 | sweating, dizziness |
Patient experienced light headedness, diaphoresis, stated "i could see black spots in my eyes," but ...
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Patient experienced light headedness, diaphoresis, stated "i could see black spots in my eyes," but did not loose consciousness. She stated that she may have not eaten enough for lunch and has a fast metabolism that may have contributed to her symptoms. Patient transported from hospital vaccine center to hospital ED for further evaluation.
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| 29 | 2021-01-13 | fever, malaise, chills |
Patient received first dose of Pfizer COVID-19 vaccination last evening. This morning, she awoke and...
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Patient received first dose of Pfizer COVID-19 vaccination last evening. This morning, she awoke and went to the bathroom at approx 0700 and noticed the red, raised rash throughout her lower extremities. She further noticed the same pattern distributed throughout her entire body including scalp. She endorses only very mild to no pruritis and denies associated pain. She does endorse mild chills and malaise noticed last PM following the shot. In addition, at her office visit this morning, she had a low grade fever of 100.2 measured. She given ibuprofen in clinic, as well as recommended ibuprofen, acetaminophen and prescribed famotidine, loratadine, and diphenhydramine for her symptoms and instructed to follow back up at the clinic tomorrow. Photos were taken of the rash and sent by patient to appropriate contact.
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| 29 | 2021-01-13 | chills, headache |
Severe headache; chills; nausea; inability to work for several days; bloating; abdominal pain; This ...
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Severe headache; chills; nausea; inability to work for several days; bloating; abdominal pain; This is a spontaneous report from a contactable Physician (patient). A 29-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot: EH9899) via an unspecified route of administration in left arm on 20Dec2020 10:00 at single dose for COVID-19 immunisation. There was no relevant medical history, no known allergies. The patient was not allergic to medications, food, or other products. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, chills, nausea on 30Dec2020, 01:00 AM 10 days after first dose, requiring COVID-19 testing and inability to work for several days, and nausea, bloating, and abdominal pain persistent for 3 days. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The patient received COVID test post vaccination via nasal Swab on 30Dec2020 with result of Negative. Events outcome was recovered. No follow-up attempts are possible. No further information is expected.
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| 29 | 2021-01-13 | weakness, fatigue, sweating |
Shooting chest pains, delirium, dry mouth/throat with mild difficulty swallowing, severe weakness, s...
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Shooting chest pains, delirium, dry mouth/throat with mild difficulty swallowing, severe weakness, severe fatigue, sweating.
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| 29 | 2021-01-13 | chills, headache, fatigue |
chills; body aches; headache; nausea; fatigue; This is a spontaneous report from a contactable Physi...
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chills; body aches; headache; nausea; fatigue; This is a spontaneous report from a contactable Physician, the patient. This 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730) (dose #1), via an unspecified route of administration in the right arm on 18Dec2020 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC SUMITOMO), levonorgestrel (KYLEENA), melatonin (MELATONIN), spironolactone (SPIRONOLACTONE). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took Celebrex for an unknown indication and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 20Dec2020 at 10:00, 44 hours after receiving the vaccine, the patient developed chills, body aches, headache, nausea and fatigue. These symptoms persisted for 5 days total. She was not febrile at any time. The adverse events resulted in a doctor or other healthcare professional/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of chills, body aches, headache nausea and fatigue was resolved on 25Dec2020. It was also reported that since the vaccination, the patient had been tested for COVID-19: negative on 21Dec2020 (saliva test) and negative on 22Dec2020 (nasal swab test).
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| 29 | 2021-01-13 | lethargy, migraine | nausea migraine unable to move left arm lethargy |
| 29 | 2021-01-14 | fatigue | Extreme fatigue, muscle pain. Started about 12 hours after vaccine and lasted a full 24 hours |
| 29 | 2021-01-14 | fatigue, headache, fever | FATIGUE, FEVER, HEADACHE, N/V |
| 29 | 2021-01-14 | cold sweat, throat pain, fatigue, runny nose, respiratory tract congestion, sweating, nasopharyngitis |
Jan.13th- Diarrhea, extreme fatigue, extreme nausea, body aches, congestion, rash under eyes and on ...
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Jan.13th- Diarrhea, extreme fatigue, extreme nausea, body aches, congestion, rash under eyes and on nose (itchy and burning). Jan14- extreme fatigue, nausea, loss of appetite, rash continues but no itching, light on burning, body aches, cold, could not get warm, temp stayed around 96.0-97.0 Jan 15- fatigue, nausea, extreme congestion, sweats, symptoms of a fever over night and during day. Cold sweats, shakes, cold then hot, body aches, fatigue. These happened off and on through the day. When started feeling crappy took temp and it was 99.6-99.8. When feeling cold temper drops down to 97.0 scratchy voice voice congestion, runny nose, little sore throat, when swallowing pills or hard texture foods, sometimes drinking something. Overall feeling of a cold. I think it?s important to note that I had Covid-19 in the month of November and received my first vaccine December 22nd. I had side effects after the first shot but not nearly as bad as this time. I am nurse in a doctors office if that matters at all. I am still feeling under the weather but wanted to get these down before I forgot them.
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| 29 | 2021-01-14 | fever, fatigue | Low grade fever, pelvic pain, body ache, fatigue. Resolved. |
| 29 | 2021-01-14 | chills, headache, fatigue |
Myalgia; Chills; Nausea; Joint pain; Headache; Fatigue; This is a spontaneous report from a non-cont...
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Myalgia; Chills; Nausea; Joint pain; Headache; Fatigue; This is a spontaneous report from a non-contactable pharmacist (patient herself). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the right arm on 06Jan2021 18:15 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (lot number: EL0140, expiry date not reported) in the right arm on 18Dec2020 at single dose for COVID-19 immunisation. On 07Jan2021 at 02:00, the patient experienced myalgia, chills, nausea, joint pain, headache and fatigue. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on 08Jan2021 at 02:00. No follow-up attempts are possible. No further information is expected.
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| 29 | 2021-01-14 | headache, fatigue |
body aches; Nausea; vomiting; fatigue; headache; lymphadenopathy; This is a spontaneous report from ...
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body aches; Nausea; vomiting; fatigue; headache; lymphadenopathy; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0142), via an unspecified route of administration on the left arm on 07Jan2021 08:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included ankylosing spondylitis, migraine, anxiety, and insomnia. Concomitant medications included fluvoxamine (FLUVOXAMINE), and adalimumab (ADALIMUMAB). The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (lot/batch number: EJ1685) via unknown route of administration on the left arm on 17Dec2020 17:30 at a single dose for COVID-19 immunization. On 07Jan2021 18:00, the patient experienced Nausea, vomiting, fatigue, headache, lymphadenopathy, and body aches. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events. The patient recovered from the events in Jan2021. No follow-up attempts are possible. No further information is expected.
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| 29 | 2021-01-14 | chills, body temperature increased, fatigue, headache |
on 1/12 symptoms experienced : temp99.5-99.8, Shivering Chills, chills, body aches, headache nausea...
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on 1/12 symptoms experienced : temp99.5-99.8, Shivering Chills, chills, body aches, headache nausea , vomitingx4 and fatigue
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| 29 | 2021-01-14 | fever |
whole right arm is in pain; have a swollen lymph node (i think?) around right clavicle area; Pain wi...
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whole right arm is in pain; have a swollen lymph node (i think?) around right clavicle area; Pain with minor touch to clavicle and upper arm (at site of injection); body/muscle aches; body/muscle aches; nausea; At 0230 on 07Jan21 I woke up shivering with a high fever; heart rate of greater than 100BPM all day on 07Jan21; This is a spontaneous report from a contactable Nurse reporting for self. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: El3248), via an unspecified route of administration in right arm on 06Jan2021 15:30 at single dose for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. At 0230 on 07Jan2021 patient woke up shivering with a high fever. Didn't realize it was a fever until 5am when woke up more, temperature taken at that time was 100.6. Fever stayed all day until 2000, no less than 99.0 even with Tylenol and ibuprofen until that time. Also developed body/muscle aches around 1200 on 07Jan2021, and some nausea. Got sent home from work that day. On 08Jan21 patient synced my (brand withheld) and checked my heart rate for day before. Didn't know it till then, but had heart rate of greater than 100BPM all day on 07Jan2021. Highest it got was 130, my resting heart rate is usually in the 60s. Also on 08Jan2021 no more fever, but whole right arm is in pain and have a swollen lymph node around right clavicle area. Pain with minor touch to clavicle and upper arm (at site of injection). Will be going to visit a doctor to make sure it is just a swollen lymph node since it is now 09Jan08Jan2021 and it's still swollen and there's still a lot of pain to R arm. Outcome of event fever was recovered, of others was not recovered.
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| 29 | 2021-01-15 | fever, headache, chills |
Received vaccine around 8 am, arm soreness within 4 hours of administration. At midnight (16 hours ...
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Received vaccine around 8 am, arm soreness within 4 hours of administration. At midnight (16 hours after administration), woke up with chills, body aches, headache, hands and feet hot, skin hot to touch/tactile fever.
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| 29 | 2021-01-15 | chills, headache, sweating, fever |
Severe chills, sweats, fever like symptoms with headache and muscle fatigue starting at 2:30am at ni...
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Severe chills, sweats, fever like symptoms with headache and muscle fatigue starting at 2:30am at night and lasting all night. Symptoms became mild for the next 24 hours but lasted till next morning in a more mild fashion.
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| 29 | 2021-01-16 | sweating |
29yo female patient reports feeling her throat tingling and closing sensation in her throat with a m...
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29yo female patient reports feeling her throat tingling and closing sensation in her throat with a metallic taste and diaphoretic approximately 3 minutes after receiving vaccine. She did not report these sensations until about 15min after injection. EMS assist was immediately called and pt was brought into one of the patient rooms. She was given Epipen injection approx. 20min after injection and EMS arrived to transport patient down to ER within 1-2 minutes after Epipen administered. Patient was monitored in ER and recovered well
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| 29 | 2021-01-16 | headache |
Approximately 6 hours following the second dose in the two-dose Pfizer COVID-19 vaccination series, ...
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Approximately 6 hours following the second dose in the two-dose Pfizer COVID-19 vaccination series, I began experiencing nausea, vomiting, moderate body aches, and headaches. I have been unable to keep down liquids (including water, gatorade, and soup broth) and solids. At this time, I have continuous vomiting, with each following the intake of food and/or beverages. Physical exam is negative for redness, swelling or rash at the injection site. Additionally, I have not appreciated any fever or signs of anaphylaxis. Following my first dose in the two-dose series, I did not experience any side effects other than the expected sore arm for 24-48 hours.
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| 29 | 2021-01-16 | skin warm, chills, fever |
Around 2 AM on 1/15/21 (about exactly 12 hours after receiving the 2nd COVID vaccine injection) I wo...
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Around 2 AM on 1/15/21 (about exactly 12 hours after receiving the 2nd COVID vaccine injection) I woke up with severe chills and had a fever of 102 degrees F. Also had joint pain in knees/ankles and thigh muscle pain, as well as injection site pain. Around 9 am, fever had increased to 104.4 degrees F. After taking 1000 mg of Tylenol, fever decreased to between 100 and 101 degrees F. Around 3 pm, fever was still above 100 degrees F so took 400 mg of ibuprofen. By 5 pm, fever was finally below 100 degrees F. By 1/16/21, all side effects had resolved except lymph node in injection arm was significantly swollen, hot, and tender. By 1/17/21, side effects still resolved besides swollen and tender lymph node.
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| 29 | 2021-01-16 | throat pain, shortness of breath, headache, fever |
Headache (first and second day post vaccine) Sore throat (first and second day post vaccine) Fever (...
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Headache (first and second day post vaccine) Sore throat (first and second day post vaccine) Fever (first and second day post vaccine) Nausea (first day post vaccine) Vomiting (first day post vaccine) Chest tightness/ difficulty breathing (beginning on second day post vaccine)
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| 29 | 2021-01-17 | chills, headache, fever, fatigue |
Headache; Nausea; pain at the injection site; Fever; Chills; body ache; Fatigue; tingling/numbness a...
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Headache; Nausea; pain at the injection site; Fever; Chills; body ache; Fatigue; tingling/numbness at injection site; tingling/numbness at injection site; shoulder stiffness; altered taste; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 08Jan2021 at 11:00AM at a single dose (dose number: 2) for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced swelling at injection site, inflammation around injection site. No Known allergies (allergies to medications, food, or other products) and no other medical history. It was unknown if the patient was pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced headache, nausea, pain at the injection site, fever/chills, body ache, fatigue, tingling/numbness at injection site, shoulder stiffness, altered taste - after 2nd dose. Events with start date on 08Jan2021 at 11:30 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.
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| 29 | 2021-01-17 | malaise, chills |
Started to have symptoms and fainted; Hit her nose and has a scar now; She blacked out; hit her nose...
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Started to have symptoms and fainted; Hit her nose and has a scar now; She blacked out; hit her nose, got the scar in the nose,
she was bleeding from that scar; hit her nose, got the scar in the nose,
she was bleeding from that scar; She started to feel unwell; Chills; Nausea; Rash in her arm; She had little red in her bumps; This is a spontaneous report from a contactable physician. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. and expiry date: unknown), via an unspecified route of administration on arm on unspecified date at a single dose (2nd dose) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Physician stated, "she had no medical conditions, she was in very good you know very like standing with herself." Patient had her 1st dose of Covid vaccine on unspecified date for COVID-19 immunization. Physician (reporter) stated, "I am the parent of someone who got the COVID dose, the second dose yesterday. I am very concerned because my daughter yesterday (08Jan2021) started to have symptoms and fainted at 4:00 in the morning and hit her nose and has a scar now. She had her second dose yesterday (pending clarification), after the second dose last night she started to feel unwell, getting chills, nausea and when she got up to go to the bathroom, she fainted, she blacked out. She lives alone, she is an adult, she hit her nose, got the scar in the nose, and the bleeding wouldn't stop, she was bleeding from that scar. She told me it took two hours for bleeding to stop from that scar." When asked when the events started, Physician stated, "Last night (08Jan2021), at 4:00 am she took the shot during the day while she was at work. She said, she started to getting chills and then she was nauseated." When asked if patient was still experiencing the event, the parent reported no as patient was just resting. Also stated, "She didn't take any treatment but she said she took Tylenol." Physician further added, "I am concerned, we are going to be taking her to the urgent care now but I am concerned about what is going on with platelets and all of that because of what had happened, last night the bleeding wouldn't stop for two hours and she was alone at the night and weekends. She said, she had to lay down and then her dad is there now because he is closer, he is going to be taking care of the urgent care but I want Pfizer to know what my daughter has gone through last night after she took this second dose." Physician further added, "she is having a rash in her arm, she had little red in her bumps as well. I want her to go get checked up as soon as possible in urgent care." Patient was taking some Ibuprofen (later clarified that patient took Tylenol as treatment). She was not taking any other medication. Outcome of the events was unknown. Information Requested on Lot/ Batch number.; Sender's Comments: The reported faint was most likely due to an accident, and less likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 29 | 2021-01-17 | cough, fever, malaise |
a low grade fever; cough; doesn't feel very well; feeling yucky; soreness in the arm where vaccine w...
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a low grade fever; cough; doesn't feel very well; feeling yucky; soreness in the arm where vaccine was given; This is a spontaneous report from a contactable Nurse (reporting for herself). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, bacth/lot no: EK9231 while expiry date was unknown), intramuscular on left deltoid on 07Jan2021 16:45 at a single dose for covid-19 immunization. There were no medical history and concomitant medications reported. Patient has no prior vaccination within 4 weeks.The patient got her first dose of the COVID 19 vaccine yesterday (07Jan2021) from her employer. She started "feeling yucky" today (08Jan2021) around noon with a low grade fever,and developed a cough that was not persistent. Patient has soreness in the arm where vaccine was given. She was asking what should she do about it? Outcome of the events low grade fever, cough, feeling unwell, feeling abnormal were not recovered while vaccination site pain was unknown. The events low grade fever, cough, feeling unwell were considered serious medically significant and related to vaccine.; Sender's Comments: Based on the time association, the events fever, cough and malaise are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 29 | 2021-01-19 | fever, headache, chills | 01/19/2021 Fever- 102.0 F Headache Chills Sore arm 01/20/2021 Fever 100.1, sore arms, chills |
| 29 | 2021-01-19 | sweating, dizziness |
10 minutes after receiving the vaccine patient complained of feeling sweaty and dizzy. She had mild...
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10 minutes after receiving the vaccine patient complained of feeling sweaty and dizzy. She had mild tachycardia. She had no nausea, vomiting or diarrhea. She had no shortness of breath, or wheezing.
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| 29 | 2021-01-19 | fatigue, dizziness, headache |
About an hour after receiving the vaccine I began to feel a little dizzy, tired, and started to deve...
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About an hour after receiving the vaccine I began to feel a little dizzy, tired, and started to develop a headache. By the next day my headache became overwhelming and the the dizziness became so pronounced that I could not stand for more than 5 minutes at a time. I a had an intolerable headache on the entire bottom of my head that made my neck start to hurt. I felt nausea that did not improve until four days later. My joints were hurting sharply two days after the immunization and lasted two days. Most of my symptoms improved on the 13th of January, but were still lingering. About 5 days after the shot my symptoms resolved completely.
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| 29 | 2021-01-19 | fatigue | Extreme Tiredness x2 days Very Nauseous x2 days Sinus Headache |
| 29 | 2021-01-19 | dizziness, headache, fatigue | Fatigue, headache, dizziness, body aches on same day Two days later chest pains, joint pains |
| 29 | 2021-01-19 | dizziness, shortness of breath, malaise |
I felt q lump in my throat and tingly in hands qnd feet for a few minutes after. I then was speaking...
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I felt q lump in my throat and tingly in hands qnd feet for a few minutes after. I then was speaking with management and felt faint and short of breath, continued to be tingly. Last night 1/19/21 I had a moment of not feeling well and my heart rate went from 60s to 120s with shortness of breath and nausea qnd tingling. This continued for about 30 minutes, I was debating going to the ED for the SOB. I then became really cold and had such bad shaking I couldn't hold anything for another 20 minutes. Today I continue to have some tingling. All of this on top of the expected side effects.
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| 29 | 2021-01-19 | shortness of breath |
P29 y/o f with no pmh, on OCP's, citrus allergy (contact dermatitis), non smoker, sent to ED with pa...
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P29 y/o f with no pmh, on OCP's, citrus allergy (contact dermatitis), non smoker, sent to ED with palpitations, sob approximately 5 mins after receiving COVID vaccine. Patient describes palpitations as heart beating fast also with tingling in her tongue. She was given epinephrine and symptoms improved, however restarted shortly after. She denies chest pain, rash, oral swelling, difficulty swallowing, coughing, nausea, vomiting, syncope. Treated with benadryl, dexamethasone, famotidine
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| 29 | 2021-01-19 | headache, fever, chills |
Unrelenting headache, chills, nausea, body aches, fever of 101.3F. Onset 14 hours after vaccine. Fev...
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Unrelenting headache, chills, nausea, body aches, fever of 101.3F. Onset 14 hours after vaccine. Fever 20 hours after. Relieved with Tylenol and Motrin, ice packs.
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| 29 | 2021-01-19 | headache | headache body aches joint pain |
| 29 | 2021-01-19 | throat irritation |
vaccine recipient complained of itching/tingling in her throat after receiving vaccine. states this...
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vaccine recipient complained of itching/tingling in her throat after receiving vaccine. states this is similar to other allergen/medication reactions she has had. treated with benadryl and observed in clinic.
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| 29 | 2021-01-21 | chills, body temperature increased, headache |
12 hour post vaccination starts shaving chills and mild myalgias. Took Tylenol with low grade temps....
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12 hour post vaccination starts shaving chills and mild myalgias. Took Tylenol with low grade temps. Overnight worsening myalgias, febrile to 101, nausea, headache despite Tylenol.
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| 29 | 2021-01-21 | sweating, fatigue, chills, malaise, fever |
12/26 started feeling extreme fatigue and malaise then led to body aches, chills, sweats, nausea, lo...
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12/26 started feeling extreme fatigue and malaise then led to body aches, chills, sweats, nausea, low grade fever 99F.
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| 29 | 2021-01-21 | fever, respiratory tract congestion, headache, chills, sweating |
Chills, fever of 100.5-101 degrees, sweats, congestion, headache that came and went for about 24 hou...
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Chills, fever of 100.5-101 degrees, sweats, congestion, headache that came and went for about 24 hours
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| 29 | 2021-01-21 | chills, fatigue, headache, fever | Fever, body chills, body aches, nausea, fatigue, headache, 14 hours |
| 29 | 2021-01-21 | headache, night sweats, sweating |
First Dose- I had a headache after the shot and tremors started that even and throughout the night....
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First Dose- I had a headache after the shot and tremors started that even and throughout the night. No fevor. Arm very sore, going into neck. Second Dose- Felt find the night. Woke up that morning at 1am and with tremors and in a night sweat. Checked temp and it was only 96, but felt hot and was sweating. Woke up the next morning and my entire body, muscles and joints ached. My knuckles, ached, kept getting sharp pains in my knuckles. My jaw ached, difficulty eating. My entire body, my muscle ached, difficulty moving. I didn't get a headache till that evening. I also had severe heart burn that night, not sure if it was related, but I have never had heart burn that bad. The next morning when I woke up (5am) (now two days after my shot), again my joints hurts, I couldn't even stand. Its like my knees couldn't even support me and I had a massive headache. I went back to bed and woke around 9am, no longer had a headache, muscles still hurt. Around 11am, all of a sudden, muscles and joints felt fine. The only thing (day three) is my arm pit on my left side where i got the shot is bothering my extremely bad. I was able to put an ultrasound probe on my axilla area, and I have swollen lymph nodes in my axilla in the area that is very painful. I also have a dull pain in my elbow.
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| 29 | 2021-01-21 | headache |
Hand of arm that vaccination was administered in began hurting, tongue tingling, & mouth feeling wie...
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Hand of arm that vaccination was administered in began hurting, tongue tingling, & mouth feeling wierd, light headache
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| 29 | 2021-01-21 | headache, fatigue | Headache, fatigue, soreness at injection site, mild nausea |
| 29 | 2021-01-21 | sweating, dizziness |
Hypertensive (167/91), tachycardia HR of 126, flushing, dizzy, dry mouth, sweating. patient refused...
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Hypertensive (167/91), tachycardia HR of 126, flushing, dizzy, dry mouth, sweating. patient refused further care and her symptoms improved then left the waiting area at 2:55pm. Before leaving, her vitals were BP 133/69, HR 70 and SpO2 100% on room air.
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| 29 | 2021-01-21 | dizziness, fatigue, headache |
I woke up the morning after the vaccine and felt very nauseous with occasional lightheadedness. I wa...
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I woke up the morning after the vaccine and felt very nauseous with occasional lightheadedness. I was also extremely fatigued and found it difficult to get out of bed or off of the couch. I had a severe headache that lasted the majority of the day. Thursday's are typically my day off therefore I did not have to call out of work sick, however I most likely would have if I had been scheduled that day.
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| 29 | 2021-01-21 | dizziness |
LIGHTHEAEDED, FEELING WOOZY HEART RATE 140 -160 BP UP TO 150/80 EXPERIENCED SIMILAR WITH FIRST D...
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LIGHTHEAEDED, FEELING WOOZY HEART RATE 140 -160 BP UP TO 150/80 EXPERIENCED SIMILAR WITH FIRST DOSE OF VACCINE.
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| 29 | 2021-01-21 | chills, fever |
Pain on area of injection so bad I can?t move or use my right arm. Started around 7:30pm the day of ...
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Pain on area of injection so bad I can?t move or use my right arm. Started around 7:30pm the day of the vaccination. Day after vaccination I have fever, nause, joint pain, chills, and the pain in the arm persists.
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| 29 | 2021-01-21 | fever | body aches for 36 hours and low grade fever for unknown amount of time |
| 29 | 2021-01-21 | chills, fatigue | chills, severe body aches, upset stomach, fatigue |
| 29 | 2021-01-24 | migraine |
About 24 hours after 2nd dose of vaccine received 1/23/21, really intense migraine started. Started ...
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About 24 hours after 2nd dose of vaccine received 1/23/21, really intense migraine started. Started about 4pm, lasted through going to sleep at 9pm, and then woke up fine.
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| 29 | 2021-01-24 | fever, shortness of breath | Body aches and joint pain increased over the day. Had a fever and no appetite. Shortness of breath. |
| 29 | 2021-01-24 | fatigue, dizziness | Body aches, fatigue, dizziness, brain fog. |
| 29 | 2021-01-24 | chills, headache, fatigue |
Body aches; chills; nausea; headache; arm pain; fatigue; received second dose of BNT162B2 on 09Jan20...
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Body aches; chills; nausea; headache; arm pain; fatigue; received second dose of BNT162B2 on 09Jan2021; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received second single dose of BNT162B2 (Pfizer, solution for injection, batch/lot number and exp date not reported), intramuscular (left arm) on 09Jan2021 11:00 for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included migraines. The patient was not pregnant. There were no concomitant medications. No other vaccine was received in four weeks. No other medication within two weeks. The patient previously took acetylsalicylic acid (ASPIRIN) wherein patient had known allergies and anaphylaxis. The patient received the first single dose of BNT162B2 on 22Dec2020 15:00, Intramuscular (left arm). The patient received second dose of BNT162B2 on 09Jan2021 11:00. The patient experienced body aches, chills, nausea, headache, arm pain, and fatigue on 09Jan2021 21:00 (09:00 pm). The patient did not have COVID prior vaccination. Patient was not Covid tested post vaccination. Treatment for AE included paracetamol (TYLENOL) OTC every 4 hours x 24 hours. The patient recovered from the events body aches, chills, nausea, headache, arm pain, and fatigue on an unspecified date in Jan2021. Information about lot/batch number has been requested.
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| 29 | 2021-01-24 | headache, nerve pain, fatigue |
Dose 1 received 12/23/20 - had mild symptoms of fatigue and headache on 12/24/20. Dose 2 received 1/...
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Dose 1 received 12/23/20 - had mild symptoms of fatigue and headache on 12/24/20. Dose 2 received 1/14/21. Initial symptoms of mild/dull dental pain started on 1/19/20. on 1/21/21 and 1/22/21 started getting EXTREME right-sided oral/facial nerve pain/spasms that migrated to head that occurred intermittently every 30-60 min and lasted 2-5 min at a time in the evening. Saw dentist on 1/22/21 to check for issues with teeth, no dental issues were found on exam and on xray. Symptoms similar to trigeminal neuralgia/ bells palsy. Called Teledoc on 1/22 who suspected bell's palsy and prescribed prednisone 50 mg po qday x 5. Nerve pain attacks went always after first dose of prednisone. Currently still left with mild dull right-sided pain.
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| 29 | 2021-01-24 | chills, fatigue, headache, chills, headache, fatigue | Fatigue, chills, headache and muscle aches |
| 29 | 2021-01-24 | throat pain, shortness of breath |
Mild Shortness of breath for about 24hrs. Swollen lip from about 4:15pm into next morning until abou...
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Mild Shortness of breath for about 24hrs. Swollen lip from about 4:15pm into next morning until about 8:00 am. Sore throat for about 24 hrs. All treated with Benadryl from home.
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| 29 | 2021-01-24 | fever, chills, shortness of breath | PATIENT REPORTS CHILLS, FEVER, BODY ACHES, SHORTNESS OF BREATH BEGINNING 12 HOURS POST VACCINE #2 |
| 29 | 2021-01-24 | malaise, chills, migraine, fatigue, headache |
Severe injection site pain that began around 2 hours and went into the evening, severe in the evenin...
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Severe injection site pain that began around 2 hours and went into the evening, severe in the evening and night. Light soreness continued over the next day. 3 hours after receiving the 2nd vaccine, nausea, loss of appetite and general 'unwell' feeling began. Nausea, fatigue, loss of appetite, headache continued the rest of the first day. Symptoms impacted ability to work, went home early from work. Day 2: splitting headache, migraine, sinus pressure, joint pain which began in hips then spread to elbows, ankles, knees; muscle pain began in left calf then spread to shin. Injection site soreness was not severely painful any longer, mild pain. Loss of appetite continued. Nausea decreased, and no longer present by afternoon of day 2. Fatigue, increased sleep, sinus pressure in eyes, and cold chills persisted. Day 3: Migraine was present still upon waking and continued for whole day; loss of appetite remained but improved by late afternoon on day 3. Joint and muscle pain continued for duration of day 3. Fatigue continued. Increased need for sleep most noticeable today. For the first time, ibuprofen was taken for symptoms after receiving the vaccine almost 50 hour prior. Day 4: was able to return to work for the first time. Headache continued throughout day, nausea in the evening. Day 5: Headache continued but went away. Day 6 and Day 7, mild headache.
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| 29 | 2021-01-24 | headache, fatigue | severe headache, Muscle/body aches, severe Fatigue |
| 29 | 2021-01-25 | fatigue, weakness, headache | Body aches, fatigue, HA, weakness, increased BP |
| 29 | 2021-01-25 | chills, headache, fatigue | Body aches, headache, nausea, vomiting, chills, fatigue, arm tenderness |
| 29 | 2021-01-25 | headache, dizziness |
Dizziness within 15 minutes of receiving vaccine; headache; high blood pressure; This is a spontaneo...
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Dizziness within 15 minutes of receiving vaccine; headache; high blood pressure; This is a spontaneous report from a contactable other health care professional. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), intramuscular on 24Dec2020 08:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included allergic to nuts and peaches. There were no concomitant medications. On 24Dec2020 08:15, the patient experienced Dizziness within 15 minutes of receiving vaccine; couple of hours after patient reported headache and high blood pressure x2 days. After 2 days both headache and high blood pressure subsided. The patient received treatment for the event headache (Tylenol). It was reported that the patient had a physician office visit. The outcome of the event dizziness was recovered on an unspecified date, while the events headache and hypertension was recovered on 26Dec2020.
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| 29 | 2021-01-25 | influenza like illness |
Enlarged lymph nodes on the left side of her neck and under the left armpit; Flu like symptoms; The ...
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Enlarged lymph nodes on the left side of her neck and under the left armpit; Flu like symptoms; The lymph nodes are also a little painful.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 06Jan2021 at single dose by injection in the left arm for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced flu like symptoms on 10Jan2021, enlarged lymph nodes on the left side of her neck and under the left armpit on 11Jan2021, the lymph nodes are also a little painful in Jan2021, this is on the same side that she received the vaccine, on the left. The outcome of the events was not recovered.
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| 29 | 2021-01-25 | fatigue, chills |
Fatigue; Sensitive skin; Chills; Body aches; This is a spontaneous report from a non-contactable oth...
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Fatigue; Sensitive skin; Chills; Body aches; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176), intramuscular in the left arm on 11Jan2021 12:30 at a single dose for COVID-19 immunization. The patient's medical history included diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek5730), intramuscular in the left arm on 12Dec2020 11:30 at the age of 28 years old for COVID-19 immunization. The patient had not been tested for COVID-19 since the vaccination. On 11Jan2021 20:00, the patient experienced fatigue, body aches, sensitive skin, and chills. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. No follow-up attempts are possible. No further information is expected.
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| 29 | 2021-01-25 | chills, fever |
Fever; nausea; vomiting; chills; body aches; This is a spontaneous report from a contactable nurse (...
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Fever; nausea; vomiting; chills; body aches; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date then received the second dose on the left arm on 11Jan2021 08:00 both via an unspecified route of administration at a single dose for Covid-19 immunization. The patient medical history was reported as none. The patient takes multivitamins. On 11Jan2021 19:00, the patient experienced fever, nausea, vomiting, chills and body aches. The patient did not received any treatment for all the reported events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 29 | 2021-01-25 | fever, headache, dizziness |
HA, dizziness, minor chest pain, body chills, fever starting 1/24/21 Notably, pt had an IV iron infu...
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HA, dizziness, minor chest pain, body chills, fever starting 1/24/21 Notably, pt had an IV iron infusion on 1/22/21
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| 29 | 2021-01-25 | dizziness |
swelling on the face; dizzy; This is a spontaneous report from a contactable consumer (patient). A 2...
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swelling on the face; dizzy; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL1284), via an unspecified route of administration in the left arm (upper shoulder) on 11Jan2021 at a single dose for COVID-19 immunisation. The patient has no other medical history and no concomitant medications. The patient stated that she got the first shot for the covid vaccine yesterday in the evening and now she is feeling swelling on the face. When she got up in the morning, she felt swelling on the face. She is asking on what she has to do. She also felt a little dizzy. She was dizzy when she got up in the morning, she did not feel anything yesterday, she felt everything today. The outcome of the events was not recovered. She has had no positive test for covid before the vaccine. She had a negative test a few days ago this month in Jan2021. She got the test on a Monday and got the results on Friday.
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| 29 | 2021-01-26 | migraine, weakness, cough, dizziness, shortness of breath, headache, fatigue, fever |
1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressu...
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1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours, took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness
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| 29 | 2021-01-26 | chills, headache |
Approximately 10 hours after receiving 2nd dose of vaccine, onset of moderate joint pain, headache, ...
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Approximately 10 hours after receiving 2nd dose of vaccine, onset of moderate joint pain, headache, body aches and chills noted. Symptoms persisted for 16 hours without intervention of medication. After 16 hours, symptoms were alleviated with 2 doses of 1000mg acetaminophen taken 6 hours apart. 1st dose at 11am on 1/26/21 and second dose at 5pm on 1/26/21
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| 29 | 2021-01-26 | headache | Headache early morning, and chest pain. |
| 29 | 2021-01-26 | fever | Low-grade fever, muscle and joint pain, major depressive episode |
| 29 | 2021-01-26 | headache |
Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Headache-...
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Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Headache-Severe, Systemic: Other- Itching-Severe
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| 29 | 2021-01-28 | nerve pain |
1week after second shot started experiencing facial nerve pain. No medical history of any pain befor...
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1week after second shot started experiencing facial nerve pain. No medical history of any pain before. Negative etiology from dentist. Received 5 day course of prednisone 50mg daily which resolved pain, however 1 day after finishing course pain returned. Worse at night with bouts of pain every 30 minutes when trying to sleep. Received steroids and carbamazepine from internal medicine doctor but this has not helped for this episode. Max doses of Tylenol and ibuprofen have not helped this episode.
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| 29 | 2021-01-28 | migraine, body temperature increased, chills, malaise, fever |
Chills started around 8:30pm, uncontrollable shaking from the chills, my skin hurt. My temperature w...
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Chills started around 8:30pm, uncontrollable shaking from the chills, my skin hurt. My temperature was 103.5F when I checked it at 12:30am. I removed clothing and put ice on my neck, and took tylenol and the fever came down to 102.5F in 30 min. I had a moderate headache, felt lightheaded and a little disoriented, and nauseous. The following morning and the entire next day I had a moderate to severe headache, malaise, nausea, and a low grade temp 99-99.8F.
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| 29 | 2021-01-28 | chills, fever, headache | FEVER, CHILLS, HA |
| 29 | 2021-01-28 | headache, fever | Pregnant. Due august 2, 2021 Having fever (up to 100 F), headache, nausea, vomiting, aches |
| 29 | 2021-01-28 | fatigue, fever | Started with a fever that progressed to a Chinese, fatigue up to 102.3 at worst for two days. |
| 29 | 2021-01-28 | sweating, skin warm |
The date of injection I didn't have any symptoms. The next morning i woke up and my arm felt like it...
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The date of injection I didn't have any symptoms. The next morning i woke up and my arm felt like it was on fire. I had a rash on the opposite arm that i had the injection. I took benadryl to help with the rash in the morning and at night. That night i was freezing and i woke up in a sweat. This morning i woke up and the rash looks worse.
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| 29 | 2021-01-28 | headache |
raspy throat; red ears; a temperature; Headache; lip swelling; tongue swelling; This is a spontaneou...
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raspy throat; red ears; a temperature; Headache; lip swelling; tongue swelling; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration on the left arm, on 14Jan2021 at 05:15, at a single dose for Covid-19 immunization. Medical history included asthma and uses an inhaler, glaucoma, nonsustained ventricular tachycardia for which she takes no medication. When she was a baby she had a reaction to the pertussis vaccine, she thought it was just a rash. Concomitant medications included topiramate (TOPAMAX) and bupropion hydrochloride (WELLBUTRIN). On 14Jan2021, the patient had a reaction after getting the vaccine. She reported that she had lip and tongue swelling. On the day of the report she still has the lip swelling. On 15Jan2021, the patient also had a raspy throat, red ears, a temperature, and headache. The center where she got the vaccine gave her diphenhydramine hcl (BENADRYL) through injection and the swelling went down. She noted she can breath, that has been complete fine. She explained that the lip and tongue swelling had gone completely down last night after the diphenhydramine hcl, but the lip swelling has come back as she has not taken any diphenhydramine hcl yet at the time of the report. She plans on taking some soon. The outcome of the event of tongue swelling was recovered on 14Jan2021 and outcome of other events was not recovered.
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| 29 | 2021-01-28 | chills, headache |
the redness around the site came back; the redness around the site came back; headache; body aches; ...
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the redness around the site came back; the redness around the site came back; headache; body aches; chills; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EL3246 and Expiration Date unknown) via intramuscularly on 12Jan2021 08:15 AM (Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EK5730 and Expiration Date unknown) via intramuscularly on 21Dec2020 05:15 PM (Right arm) at single dose for COVID-19 immunisation. With first dose, patient had redness to the site the day after injection. It was probably about a quarter to half dollar in size and was red and inflamed but went away and faded as the week went on. Then about a week after that vaccine, the redness came back but it was itchy, hot to touch, and hard. Over the next day or so it grew quite large (have pictures for comparison throughout the days). Treatment included oral antibiotic and it slowly began to fade and go away. Other medical history was reported as Attention deficit hyperactivity disorder (ADD), eczema, psoriasis. The concomitant medications included unspecified Birth control, vitamin b complex (VITAMIN B) and ergocalciferol (VIT D). No other vaccine in four weeks. After second vaccine patient had a typical immune response- headache, body aches, chills, etc on the first day after vaccination and then on the second day post vaccination the redness around the site came back. Patient worried it was going to continue to grow again. The outcome of events was unknown.
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| 29 | 2021-01-29 | dizziness, fever, weakness, headache |
"Pfizer-BioNTech COVID-19 Vaccine EUA" I received my 2nd dose of the Pfizer COVID-19 vaccine on Jan....
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"Pfizer-BioNTech COVID-19 Vaccine EUA" I received my 2nd dose of the Pfizer COVID-19 vaccine on Jan. 20th, 2021. On Jan. 21st, 2021, I woke up feeling feverish. I went to use the bathroom, and after washing my hands I walked towards the bathroom door and felt light-headed and dizzy. Suddenly, I passed out and hit my head and upper neck on the tile floor. My parents heard the sound of my fall and luckily rushed to the bathroom. They found me lying unconscious on the floor with my eyes rolled up for what felt like more than a minute. I regained consciousness on my own, and I drank water with a bit of sugar and salt mixed in. I felt too weak to get up and walk, and the back of my head and upper neck were in pain. I told my parents to call 911 as I wanted to make sure that there was no serious damage to my brain or neck area. I went to the local hospital in an ambulance. I was taken to the emergency room: Vitals were done and my temperature ranged from then was 99.5-101F and my heart rate was high- it stayed around 112 bpm for some time I was given 2 L of IV Saline Fluids EKG result: no clinical abnormalities CT head/neck/spine: negative 2 different types of COVID-19 tests: results were both negative Bloodwork: CBC/BMP/D-dimer: no clinical abnormalities Chest Xray: negative 2D- doppler ultrasound: negative Holter monitor: negative for irregular heart rhythm I was discharged the same day around 4:30pm
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| 29 | 2021-02-01 | dizziness, headache |
Because of patient's previous reaction, pt premedicated with famotidine 20 mg, benadryl 25 mg, ibupr...
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Because of patient's previous reaction, pt premedicated with famotidine 20 mg, benadryl 25 mg, ibuprofen 400 mg 30 min before injection. Received vaccine at 9:15 AM. She initially felt well, but about 20-30 minutes after administration began to feel dizzy. Then had nausea, vomiting, dizziness, severe headache, feeling of her body being heavy, arm pain at site of administration. Vitals were monitored/stable throughout. Pt was given Zofran 4 mg disintegrating tab at 9:50, which did not do much to relieve sx. However, at 10:35 she noted that headache was gone, although still had dizziness, arm pain. By 11:08 no longer had symptoms except for arm pain. By 11:43 still feeling back to normal except for arm pain.
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| 29 | 2021-02-03 | chills, nasal congestion, fatigue |
Abdominal pain, diarrhea, pain in joints, tiredness, nausea, pain in the chest, chills, nasal conges...
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Abdominal pain, diarrhea, pain in joints, tiredness, nausea, pain in the chest, chills, nasal congestion and discomfort in the throat.
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| 29 | 2021-02-05 | fatigue |
32 Weeks pregnant Due Date: 4/1/2021 1st child About 8 hours after I started with nausea and a litt...
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32 Weeks pregnant Due Date: 4/1/2021 1st child About 8 hours after I started with nausea and a little fatigue. I woke up the next morning with joint and muscle pain. That lasted a full day along with the nausea. I did take Tylenol, it didn't take it away but made it more tolerable. This lasted for about two days.
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| 29 | 2021-02-08 | headache, shortness of breath |
trouble breathing; Patient experienced itching on legs arms and face along with hives; Patient exper...
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trouble breathing; Patient experienced itching on legs arms and face along with hives; Patient experienced itching on legs arms and face along with hives; Headache getting severe by the minute; This is a spontaneous report from a contactable pharmacist. A 29-year-old female patient received 2nd dose of bnt162b2 (BNT162B2; lot number EN5318) on 25Jan2021 intramuscular at right arm for COVID-19 immunization. Medical history was not reported. The patient had no COVID prior to vaccination. Historical vaccine include BNT162B2 for COVID-19 immunization. The patient had no other vaccine in weeks, concomitant drugs was none. The patient experienced headache getting severe by the minute. Patient experienced itching on legs arms and face along with hives and trouble breathing. Event start date was 25Jan2021. One epinephrine was received. Patient was taken to the hospital. The events resulted in Emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events headache, dyspnea, urticaria and pruritus are possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 29 | 2021-02-10 | fever, night sweats |
anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feelin...
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anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; in the evening arm swelled/swelling went down to size of pin hole; there was a welt at the vaccination site / there was still a little knot on arm; fever; night sweats; body rash/ rash beneath eyes; blister sores; swelling of eyes; arm was painful and is still; This is a spontaneous report from a contactable consumer. A 29-years-old female patient, a registered nurse, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number BK9231, in Hospital, via an unspecified route of administration in left arm on 04Jan2021 at 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of the vaccination. Concomitant medications included ibuprofen and cetirizine hydrochloride (ZYRTEC). The patient reported that 2 mins after the shot, her left arm felt heavy and was hard to move and, on 04Jan2021 at 14:15 she had tingling/dead feeling; in the evening arm swelled and there was a welt at the vaccination site. On an unknown date in Jan2021 she had fever at 102 °F for 48 hours and swelling went down to size of pin hole; her arm was painful and was still sore, there was still a little knot on arm. On 07Jan2021 she experienced an anxiety attack; 20 days after, in Jan2021 the patient experienced night sweats. She also experienced body rash and little blister sores on her body and both arms, swelling of eyes and rash beneath eyes. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered to the patients for the events. On 25Jan2021 the patient underwent COVID-19 test via Nasal Swab which showed negative results. The event "Fever" resolved after 48 hours, whereas the outcome of all the reported events was unknown at time of the report.
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| 29 | 2021-02-16 | shortness of breath |
Difficulty breathing- received EpiPen dose, patient was able to breath normally again Shortly therea...
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Difficulty breathing- received EpiPen dose, patient was able to breath normally again Shortly thereafter patient was witnessed to have seizure like activity, EMS was called and administered Ativan and Benadryl in route to ED
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| 29 | 2021-02-21 | chills, cold sweat, fatigue, headache |
Fatigue, cold sweat/chills, slight headache, muscle/joint pain, skin painful to the touch (typically...
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Fatigue, cold sweat/chills, slight headache, muscle/joint pain, skin painful to the touch (typically occurs to me right before getting a fever or becoming sick)
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| 29 | 2021-02-21 | headache |
Headache: in middle of forehead start date: 2-20-2021 at 9:30pm and ended on 2-21-2021 at 8am. No co...
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Headache: in middle of forehead start date: 2-20-2021 at 9:30pm and ended on 2-21-2021 at 8am. No conmeds taken.
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| 29 | 2021-02-21 | weakness, chills, headache, dizziness, fever, sweating |
High fever for 24 hours that couldn't be controlled with OTC meds, chills/sweats, severe headache a...
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High fever for 24 hours that couldn't be controlled with OTC meds, chills/sweats, severe headache and dizziness, shaking, muscle cramps (all lasted about 24 hours straight through. Muscle and joint pain and weakness continued through 48 hours. Left arm, under arm and shoulder were very tender and mobility restricted through day 3.
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| 29 | 2021-02-21 | fatigue, fever, headache |
Nausea, fever, chills, aches and pains, fatigue, headache, neck ache, ear pain, swollen lymph nodes,...
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Nausea, fever, chills, aches and pains, fatigue, headache, neck ache, ear pain, swollen lymph nodes, sore arm. These symptoms lasted about 2 days total.
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| 29 | 2021-02-21 | fever, chills, fatigue, influenza like illness |
She developed flu like symptoms the day after receiving the vaccine, including, fever, chills, nause...
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She developed flu like symptoms the day after receiving the vaccine, including, fever, chills, nausea, vomiting, fatigue, myalgias, rash, which have persisted for 6 days.
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| 29 | 2021-02-21 | weakness |
Symptoms 01/24/2021- numbness, weakness, tingling bilateral legs. Lost inability to walk and bladder...
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Symptoms 01/24/2021- numbness, weakness, tingling bilateral legs. Lost inability to walk and bladder control Admitted to hospital 01/24/2021-1/26/21. Not diagnosed. Had 4 MRIS and a lumbar puncture 02/3/2021- was in ED at hospital due vision issues/double vision- discharged same day. Repeated 4 MRIS and blood work, and lumbar puncture. 02/09/2021- patient was seen at a neurologist, due to numbness in bilateral hands and arms. And was admitted to Medical Center until 02/13/2021. Ruled out MS, GB, repeated 4 MRIS and LP. Was sent home with home health and PT. Saw PCP 02/19/2021, Did paperwork for disability and removed from work until 04/30/2021. PCP ordered more blood work up to 35 tubes of blood done on 02/17/2021. Will not be ready until 14 days post draw. Patient is still complaining of tingling on bilateral hands and feet, and weakness. Mainly sensory nerves related symptoms.
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| 29 | 2021-02-21 | weakness, fever |
The morning after the vaccine, pt noted low grade fever and general weakness, syncope with loss of c...
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The morning after the vaccine, pt noted low grade fever and general weakness, syncope with loss of consciousness for undetermined time period, facial trauma resulting in fractures of maxilla and teeth
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| 29 | 2021-02-22 | sweating, weakness, head discomfort, dizziness |
Approx 5 minutes after receiving the vaccine, client started c/o feeling hot, sweaty, Left side of t...
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Approx 5 minutes after receiving the vaccine, client started c/o feeling hot, sweaty, Left side of tongue numb and she had pressure on the left side of her head, her BP dropped and she felt weak. No medications given. She felt better after 10 minutes. She called her doctor and he gave her an epi pen and told her not to take the 2nd dose of Pfizer. She says she felt dizzy and weak for 3 weeks afterwards, but fine now.
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| 29 | 2021-02-22 | shortness of breath, dizziness |
Lightheaded, short of breath, tightness across chest, unsteadiness in legs, cloudy brain. Went to ER...
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Lightheaded, short of breath, tightness across chest, unsteadiness in legs, cloudy brain. Went to ER with labs done (tryp 4.8). Discharged.
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| 29 | 2021-02-22 | weakness, fatigue |
Rash developed on left arm below vaccination and went across the chest and then 24 hours later hives...
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Rash developed on left arm below vaccination and went across the chest and then 24 hours later hives on face and behind ears and some on shoulders and arms client took Benadryl by pm the face was red without hive and by Sunday the Hives had disappeared. Monday redness on face and by Tuesday all hives had resolved. Tuesday still very weak and fatigued and if sits upright HR increases, eating and drinking without interruption.
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| 29 | 2021-02-23 | fever |
Firs and Second dose done in left arm 2 days after second vaccine I had a fever and the top left of ...
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Firs and Second dose done in left arm 2 days after second vaccine I had a fever and the top left of my mouth and teeth have been numb and I can?t feel anything. It?s the top 3 to 3 teeth and my gums that feel as if I was getting numbed at the dentist. It still hasn?t gone away I can?t feel my lip and my teeth hurt to chew anything and are sensitive to cold and hot and throbbing. I went to the dentist and they said it was fine. So I?m here reporting it and now I will be going to my PCP. Thank you
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| 29 | 2021-02-23 | migraine |
Site swelling and high pain for 3 days; Site swelling and high pain for 3 days; Global Migraines; Ir...
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Site swelling and high pain for 3 days; Site swelling and high pain for 3 days; Global Migraines; Irritated; This is a spontaneous report from a non-contactable nurse (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9262) via an unspecified route of administration on the left arm on 21Jan2021 22:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 31Dec2020 for COVID-19 immunization. On 22Jan2021 03:00 AM, the patient experienced site swelling and high pain for 3 days. Global Migraines that I have never hard before 2 days after vaccination and irritated. Events treatment included paracetamol (TYLENOL), cetirizine (ZYRTEC) and diphenhydramine (BENADRYL). Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
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| 29 | 2021-02-24 | fatigue, fever, chills, cough |
Dizziness, Lightheaded, Chills, the first time I had to stop because couldn't drive, I had spasm's a...
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Dizziness, Lightheaded, Chills, the first time I had to stop because couldn't drive, I had spasm's around the injection site, Generalized Numbing, the symptoms of the fisrt dose lasted one week. I don't like to take medicine and I had no choice but take Panadol every 4 hours and apply ice to treat the muscular pain. I went to emergency and was told that I had an urine infection (which is very rare on me), and was treated with antibiotics. With the second dose I took acetaminophen 500 mg befor the vaccine, that helped because the day of the shot I didn't have pain, but the numbness was like if I couldn't connect my body to the brain. Couldn't talk properly, sleep 2 hours during the day, is funny that I applied ice on the injection site (Me thinking) but the pain doesn't go away, when the ice melts I notice that I applied the ice on the wrong arm. That's what I mean when I talk about numbness. Fever of 39.8F and Chills even today . Some cough and dry throat (Dryness can be because I'm a teacher) and constant tiredness.
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| 29 | 2021-02-25 | chills |
Rigors; pain at injection site; body aches; This is a spontaneous report from a non-contactable nurs...
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Rigors; pain at injection site; body aches; This is a spontaneous report from a non-contactable nurse reporting for herself. A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 29-year-old via intramuscular in the left arm on 28Jan2021 01:00 PM at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was not allergic to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient experienced rigors, pain at injection site, body aches on 29Jan2021 at 03:00 AM. No treatment was received for the events. The nurse considered the events as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
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| 29 | 2021-02-28 | runny nose, headache |
Joint/muscle aches; Joint/muscle aches; Mild headache; Sneezing; Sniffling; This is a spontaneous re...
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Joint/muscle aches; Joint/muscle aches; Mild headache; Sneezing; Sniffling; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3248, expiration date was unknown), via an unspecified route of administration in the left arm on 27Jan2021 at 11:45 at a single dose for COVID-19 immunization. The vaccine facility type was reported as the hospital. The patient had no medical history; she had no known allergies. Concomitant medication included escitalopram. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She was not tested for COVID post vaccination. On 28Jan2021 at 15:00, or around 30 hours post-vaccination, the patient experienced joint/muscle aches, mild headache, sneezing, and sniffling. The patient did not receive any treatment for the adverse events (AEs). The patient was not recovered from all the events.
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| 29 | 2021-03-02 | chills |
Approximately thirteen hours after I received my second dose of the vaccine I started having crampin...
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Approximately thirteen hours after I received my second dose of the vaccine I started having cramping in my abdomen. The cramping got increasingly worse and I started to get really bad chills. The cramping feeling turned into a stabbing pain and reached a threshold that I could no longer stand so my husband had to drive me to the ER. I have never been in so much pain. Once it the ER I received medicine for the pain and a CT scan that revealed that I had appendicitis and needed to have it removed with an appendectomy.
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| 29 | 2021-03-02 | dizziness, fatigue |
Dizziness; tiredness; This is a spontaneous report from a contactable consumer (patient). A 29-year-...
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Dizziness; tiredness; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received first dose of BNT162B2 (brand=Pfizer), via an unspecified route of administration (vaccine location=left arm) on 29Jan2021 12:45 at a single dose for COVID-19 immunization at a hospital. Medical history was not reported. Concomitant medications included prenatal vitamins. No other vaccine in four weeks. No covid prior vaccination. On 29Jan2021 06:30 PM (as reported), the patient experienced dizziness and tiredness, onset less than one hour post injection. Symptoms worsened into following day. No treatment received for the events. No covid test post vaccination. The outcome of the events was not recovered. Information on batch/lot number was requested.
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| 29 | 2021-03-02 | fever, chills, fatigue, headache |
fever; chills; aches; headache; fatigue; loss of appetite; Dulled taste; patient received the first ...
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fever; chills; aches; headache; fatigue; loss of appetite; Dulled taste; patient received the first dose on 12Jan2021 and the second dose was on 29Jan2021; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: El9362; expiration date: unknown) at vaccination age of 29-year-old via an unspecified route of administration in the left arm on 29Jan2021 16:45 at a single dose for covid-19 immunization. Medical history included hypothyroidism, PCOS (polycystic ovarian syndrome) and penicillin allergy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included levothyroxine, metformin and vitamin nos (MULTIVITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: Ek4176) at vaccination age of 29-year-old via an unspecified route of administration in the left arm on 12Jan2021 16:45 at a single dose for covid-19 immunization but had lump on neck, sore arm, diarrhea starting day 3 through today and sore rib. The patient received the most recent COVID-19 vaccine in a hospital. It was reported that the patient received the first dose on 12Jan2021 and the second dose was on 29Jan2021. On an unspecified date after the second dose, the patient had fever, chills, aches, headache, fatigue, loss of appetite and dulled taste. It was unknown if the patient received treatment for the adverse events and events were considered as non-serious. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering.
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| 29 | 2021-03-05 | dizziness |
49 hours after I began to feel dizzy, my ears clogged and I felt generally bad. I was sent to a doct...
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49 hours after I began to feel dizzy, my ears clogged and I felt generally bad. I was sent to a doctor who sent me to a hearing test. My right ear got damaged and cannot hear below ~40-50 decibel on all frequencies. + I got tinnitus. The treatment I got is Prednisolone 60 mg daily for a week. 4 days, nothing changed so far
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| 29 | 2021-03-07 | chills, headache, fever |
headache; 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2/fever; chills; muscle ac...
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headache; 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2/fever; chills; muscle aches; nausea; This is a spontaneous report from a contactable Other Health Professional reported for herself (patient). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302; expiration date not provided), intramuscular (left arm) on 02Feb2021 13:30 at SINGLE DOSE for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Patient is not pregnant. The patient has no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140; expiration date not provided), intramuscular (left arm) on 13Jan2021 for COVID-19 immunisation. The patient experienced headache, '9.5hrs after the 2nd vaccine dose a fever set in', chills, muscle aches, and nausea all on 02Feb2021 at 23:00. Patient's clinical course is as follows: 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2. To accompany the fever were chills, muscle aches, nausea, and a headache. After taking a fever reducer, the nausea stayed and the fever returned approximately 8hrs as did the chills, muscle aches, and headache. It was reported that patient took a fever reducer again and now waiting to see if that helps again. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included body temperature with result of '101.2 (9.5hrs after 2nd vaccine dose a fever set in, and climbed to 101.2)' on 02Feb2021. The patient has not received treatment for headache, chills, muscle aches, and nausea. Facility where the most recent COVID-19 vaccine was administered was reported as 'Workplace clinic'. Outcome of the events was not recovered.
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| 29 | 2021-03-14 | fatigue |
some kind of back pain, behind her heart; heart pain; pretty strong chest pain; fatigue caused by th...
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some kind of back pain, behind her heart; heart pain; pretty strong chest pain; fatigue caused by the vaccine was so profound; This is a spontaneous report received from a contactable consumer(reporting for her daughter) A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 expiry date 31Mar2021 via an unspecified route of administration on 08Jan2021 (at the age of 29-year-old) at single dose for COVID-19 immunisation. The first dose of bnt162b2 was taken on 17Dec2020. The patient's medical history included bipolar disorder. Concomitant medications included quetiapine (QUETIAPINE). The patient experienced some kind of back pain, behind her heart, heart pain and pretty strong chest pain on 08Jan2021 with outcome of recovered. In addition experienced "fatigue caused by the vaccine was so profound that was advised to not take her bipolar medication, quetiapine" on an unspecified date with outcome of recovered. It was reported that "It took 36 hours for the extreme fatigue to stop. This was very frightening because being without the medication could cause auditory hallucinations to return after 36 hours. There should be a warning for people who must take sedative medication regularly so that they can make an informed decision about whether or not to receive the vaccine".
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| 29 | 2021-03-18 | fatigue |
on the legs, hands: nerve damage; Left side: sharp shooting pains,Constant pain; fatigue; numbness; ...
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on the legs, hands: nerve damage; Left side: sharp shooting pains,Constant pain; fatigue; numbness; tingling; bruising; rash; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), via an unspecified route of administration in the left arm, on 01Feb2021 08:30, at a single dose, for covid-19 immunization. Medical history included kidney stones, BPD2 (bipolar II disorder), and anxiety; there were no known allergies. Concomitant medications included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; and imipramine taken for an unspecified indication, start and stop date were not reported. The patient had no Covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The vaccine was given at the hospital. The patient experienced left side: sharp shooting pains, constant pain; fatigue; numbness; tingling; bruising; rash and; on the legs, hands: nerve damage. All the adverse events happened on 02Feb2021 which resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient had not recovered from all the adverse events at the time of the report despite having an unspecified medication and ongoing treatment received for them. The patient also had imaging and labs on Feb2021 for these adverse events with unknown results. The patient has not been Covid-tested post vaccination.
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| 29 | 2021-03-21 | pneumonia, shortness of breath |
29 y/o female presented to hospital with complaints of SOB, skin flares secondary to history of disc...
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29 y/o female presented to hospital with complaints of SOB, skin flares secondary to history of discoid lupus, protracted vomiting, and joint pain. Side effects began 2 days after her 2nd COVID vaccine. Pt was transferred to hospital from another institution due to O2 sat in the 60s (room air), leukocytosis, and AKI. Patient was treated empirically for sepsis/pneumonia as well as lupus flare. She was also initiated on high dose steroids. Possible reaction to vaccine. Chest CT showed diffuse ground-glass opacities and no signs of pulmonary embolism. Pt was transferred from hospital to another facility given progressive organ failure, most specifically liver failure.
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| 29 | 2021-04-01 | headache, shortness of breath |
Patient described myalgias, headache and dyspnea at ER visit on 4/1/21 at 2:37 am. Patient was disch...
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Patient described myalgias, headache and dyspnea at ER visit on 4/1/21 at 2:37 am. Patient was discharged. Patient returned the same day at 15:40 cyanotic, altered, hypoxic and hypotensive. The patient was found to have profound metabolic acidosis, liver failure, renal failure. She went into cardiopulmonary arrest, was revived, rearrested and died. Patient was treated for possible sepsis, shock, liver failure.
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| 30 | 2020-12-31 | chills, headache, fatigue, shortness of breath |
12/28/2020-1230 began feeling numbness/tingling left foot, left hand, left cheek (face), intermitten...
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12/28/2020-1230 began feeling numbness/tingling left foot, left hand, left cheek (face), intermittent 1500- chest tightness, palpitations lasting 20-30 minutes 1900- feet b/l ice cold, muscle aches, chills, lasting 8 hrs 12/29/2020- upon awakening-fatigue, SOB 6 hrs, intermittent paresthesia persist left foot, left cheek, new onset teeth pain (lasts less than 1 minute) left sided headache (1-5 min) left sided back pain at SI joint 12/30- tingling sensation persist, fatigue is gone. Chills- 1-3 min duartion, intermittent. left ear pain, left headache, "pings " of left cheek, tingling back pain persists (left) 12/31/2020 noted mild left facial weakness-, left eye brow rise, unilateral wrinkle forehead, smile reduced left sided tingling persists with intermittent headache, ear pain, teeth pain sought care of PCP tx of early onset bells palsy with steroid taper + PPI Began prednisone 40 mg PO 1/1/2021 left sided back pain persists
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| 30 | 2020-12-31 | chills | Chills, myalgias and pre-syncope |
| 30 | 2020-12-31 | fever, chills, shortness of breath, cough, headache, throat pain |
Sudden onset cough, shortness of breath, and wheezing. A fever of 100.6 was noted but unsure as to w...
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Sudden onset cough, shortness of breath, and wheezing. A fever of 100.6 was noted but unsure as to when that occurred as I did not have chills. Feber has subsided. Cough, shortness of breath and intermittent wheezing remain as well as some chest pressure, sore throat, headache and chills. Coughing fits are bad enough to cause urinary incontinence but I did give birth 4 months ago so this may not be significant. No signs of allergic reactive such as redness, urticaria or swelling.
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| 30 | 2020-12-31 | throat pain, chills, runny nose, nasopharyngitis |
The next day I had a sore throat, and now it has developed into a cold. Sore throat, running nose, h...
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The next day I had a sore throat, and now it has developed into a cold. Sore throat, running nose, had some chills and body aches.
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| 30 | 2021-01-01 | fatigue, headache, fever |
100 degree fever, body aches, sore under arm/armpit of left arm (injection arm), fatigue, nausea, sl...
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100 degree fever, body aches, sore under arm/armpit of left arm (injection arm), fatigue, nausea, slight headache, swollen lymphnodes
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| 30 | 2021-01-01 | cough, chills, fever, shortness of breath |
30YO F ICU nurse obesity (BMI 35) COVID 19 on Dec 2 symptoms, Dec 3 tested positive for COVID-19. ne...
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30YO F ICU nurse obesity (BMI 35) COVID 19 on Dec 2 symptoms, Dec 3 tested positive for COVID-19. never hospitalized, outpatient only. 12/12 completed isolation 12/21 received vaccine 12/7 developed Fever chills diarrhea SOB cough Urgent care visit. RLL consolidation on CXR given doxycycline 100 mg po bid worse, fever 40 targetoid lesions to LE (started before doxy) WBC 22K tachycardic tachypneic admitted requiring 2-4L oxygen CT angio without clot, diffuse ground glass and RML dense infiltrate DDimer 7.8 LDH 599 CRP 41 procal 0.67 ferritin 500 Viral respiratory PCR negative Sputum cx with oral flora (pending) COVID ag testing neg COVID PCR 1/3 targets positive (called as indeterminate).
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| 30 | 2021-01-01 | shortness of breath |
Vaccine given at 7:05am 12:00noon, 5 hours later, I started experiencing severe chest pain, jaw pain...
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Vaccine given at 7:05am 12:00noon, 5 hours later, I started experiencing severe chest pain, jaw pain and shortness of breath in which EMS was called and I was taken to the hospital. Since then, I lost feeling in my hands and feet, numbness and tingling. I've improved however, during my recovery suffered with spinal pain, shortness of breath, very winded, muscle pain and loss of appetite to especially meat.
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| 30 | 2021-01-01 | dizziness | Very severe body aches and feeling lightheaded, causing fall on the ice |
| 30 | 2021-01-02 | sweating, chills |
Arm became very sore about 10 hours after the vaccine. Around 12 hours later became very sore throug...
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Arm became very sore about 10 hours after the vaccine. Around 12 hours later became very sore throughout entire body, had very bad chills, and was unable to sleep. By 9 am I was finally able to sleep one hour and awoke sweating, but chills had subsided. Body aches did not subside until Wednesday morning (vaccine was administered Monday).
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| 30 | 2021-01-02 | fatigue |
Become tired after returning home from getting the vaccine. I fell asleep and woke up to large hives...
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Become tired after returning home from getting the vaccine. I fell asleep and woke up to large hives on my face. Not much longer and the hives/itching spread down my back and chest. Face became swollen. Benadryl cream was initially attempted, but only briefly subsided the itching and reaction continued spreading. I took oral quick release Benadryl and was able to prevent the reaction from continuing. I had to take a secondary Benadryl dose a few hours later and extreme joint pain accompanied the allergic reaction.
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| 30 | 2021-01-03 | respiratory tract congestion, fever, throat pain, headache, chills, runny nose |
I had a sore arm the first couple of days, on the 22nd I had chills sore throat headache congestion...
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I had a sore arm the first couple of days, on the 22nd I had chills sore throat headache congestion sneezing sniffling and low grade fever 99.6. on the 23rd loose stools nasal drainage, I called the hospital hotline and I had to be off for ten days and went to Urgent care and took a rapid test and the test was positive. I have been quarantined for 14 days . The 25th was probably the worst day the 26th was a little better. the 27th symptoms were more mild and I also had diarrhea The 28th I woke up with a headache and light sniffles and the 27th I had no symptoms
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| 30 | 2021-01-03 | body temperature increased, chills |
On 12/23 around 2pm exp chills, higher temp than normal. My heart rate and BP was higher than normal...
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On 12/23 around 2pm exp chills, higher temp than normal. My heart rate and BP was higher than normal lasted about a hour. I had to miss a day and 1/2 of work.
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| 30 | 2021-01-03 | fatigue |
Patient began to experience symptoms shortly after vaccination. Pt became flushed and developed red ...
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Patient began to experience symptoms shortly after vaccination. Pt became flushed and developed red splotches over chest and neck. C/o difficulty swallowing and some GI upset. Began to shake uncontrollably. Initial BP was 149/99 and HR 118. O2 sats at 99%. Administered 25mg of benadryl and monitored patient for approximately 1 hour. After about 30-45 minute, her vitals stabilized at 120/80, Pulse 90, O2 at 100% on room air. D/C'd home at 1:32pm. 24 hours later patient c/o of hives and flushing off and on. Also complained of some GI upset and fatigue. Pt was able to return to work on 1/3/2021.
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| 30 | 2021-01-03 | headache, dizziness, sweating |
Pfizer-BioNTech COVID-19 Vaccine: On the day I received the first does of the vaccine, I felt fine u...
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Pfizer-BioNTech COVID-19 Vaccine: On the day I received the first does of the vaccine, I felt fine until about 6 hours later. At that point, I started to get very dizzy and lightheaded. Every time I opened my eyes, everything was spinning. This lasted four about 3-4 hours. I kept breaking out into sweats. I had a horrible headache for about 4 days straight. I am still continuing to having headaches. I am still having hot flashes and dizziness episodes at times that go away after about a few minutes. Two days ago, I stated to developing swelling in my hands with achy joints which has not gone away.
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| 30 | 2021-01-03 | body temperature increased |
Redness around the injection site,continued muscle pain at the injection site, warmth and numbness a...
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Redness around the injection site,continued muscle pain at the injection site, warmth and numbness and tingling locally as well. Temperature taken during our call was 99.9 F. She denies hives, dizziness, face or throat swelling or any other signs of allergic reaction. Initially after having the vaccination, she did have some GI upset that resolved after a couple of days.
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| 30 | 2021-01-04 | headache, chills, fever |
12 hours after injection I began to have chills and rigors, the rigors subsided after ~30 min. For t...
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12 hours after injection I began to have chills and rigors, the rigors subsided after ~30 min. For the next 11 hours i had chills, severe body aches, a headache and spiked a fever to 101. The following day after ~12 hrs of symptoms I began to improve slightly and all that remained was a severe headache and body aches. Now, I am about 32 hours in to the adverse event and I still have a headache and sore arm/shoulders but other symptoms have resolved.
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| 30 | 2021-01-04 | dizziness |
12/29/2020 VACCINATION. WAS IN SITTING AREA, FELT FINE. AFTER 20 MINUTES, WALKED OUT OF ROOM AND FE...
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12/29/2020 VACCINATION. WAS IN SITTING AREA, FELT FINE. AFTER 20 MINUTES, WALKED OUT OF ROOM AND FELT LIGHT HEADED AND DIZZY. NEAR SYNCOPY EPISODE, TUNNEL VISION, PALE.
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| 30 | 2021-01-04 | fever, chills, headache |
Body aches; low grade fever; chills, shivering; headache; nausea; stiff/sore arm; stiff/sore arm; Th...
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Body aches; low grade fever; chills, shivering; headache; nausea; stiff/sore arm; stiff/sore arm; This is a spontaneous report from a contactable Other Health Professional for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685) dose number 1, intramuscularly on 26Dec2020 15:30 at single dose on arm Left for COVID-19 immunization. Medical history included irritable bowel syndrome, chicken allergy and COVID-19. Concomitant medications received within 2 weeks of vaccination included clonazepam, spironolactone and melatonin, all from unknown date for unknown indication. Onset of symptoms began roughly 9hrs post vaccine. Lasted roughly 24 hours (28Dec2020). Body aches, low grade fever, chills, shivering, headache, nausea, stiff/sore arm. Adverse event start date: 27Dec2020 00:00. No treatment was received for the events. The action taken in response to the events for BNT162B2 was not applicable. Outcome of the events was resolved on 28Dec2020.
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| 30 | 2021-01-04 | fever, chills | Fever with chills |
| 30 | 2021-01-04 | nasal congestion |
I experienced nasal congestion the next morning, and redness, induration and pain on the injection s...
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I experienced nasal congestion the next morning, and redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; redness, induration and pain on the injection site. Induration and redness was around 1-1.5 inches diameter; This is a spontaneous report from a contactable physician. A 30-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration in right arm on 23Dec2020 13:30 at a single dose for covid-19 vaccination. Vaccination was done in the hospital. There were no relevant medical history and no concomitant medications. The patient was not pregnant. The patient experienced nasal congestion the next morning, on 24Dec2020 07:00, and redness, induration and pain on the injection site. The induration and redness was around 1-1.5 inches diameter. The outcome of the events was recovering. There were no treatment involved for the events. This was assessed as non-serious. Information on the lot/batch number has been requested.
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| 30 | 2021-01-04 | fatigue, chills |
Initially soreness in injection area; body backs with back, hip, and knee pain limiting mobility; bo...
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Initially soreness in injection area; body backs with back, hip, and knee pain limiting mobility; body backs with back, hip, and knee pain limiting mobility; limiting mobility; Fatigue; chills; This is a spontaneous report from a contactable Other HCP (patient). A 30-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685), via an unspecified route of administration in right arm, on 28Dec2020 03:30 PM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Relevant medical history included COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. The patient experienced Initially soreness in injection area on 29Dec2020 10:30 AM. At 19 hours after vaccination started to experience body backs with back, hip, and knee pain limiting mobility on 29Dec2020 10:30 AM. Fatigue and chills fan at 24 hour mark and are continuing now at 28 hours on 29Dec2020 10:30 AM. No treatment was received for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 30 | 2021-01-04 | cough |
It felt a little numb on the part that was injected; I kept filling the medicine drip from my nose a...
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It felt a little numb on the part that was injected; I kept filling the medicine drip from my nose and since then I have been having really bad cough; I kept filling the medicine drip from my nose and since then I have been having really bad cough; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no concomitant medications. The patient stated that she believed she had a little bit side effects on the vaccine in Dec2020. She took the vaccine about maybe more than a week ago and yesterday it felt a little numb on the part that was injected and she kept "filling the medicine" drip from her nose and since then she had been having really bad cough. The patient stated that for her cough, she took natural stuffs (unspecified). Outcome of the events was unknown. Information on the batch/lot number has been requested.
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| 30 | 2021-01-04 | headache, dizziness, fever |
It looks like one of the ingredients may have an animal cell lipid; Syncope; Dizziness; feeling fain...
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It looks like one of the ingredients may have an animal cell lipid; Syncope; Dizziness; feeling faint; like going to pass out now and then; overall achiness, severe headaches, fever; overall achiness, severe headaches, fever; overall achiness, severe headaches, fever; This is a spontaneous report from a contactable nurse reporting for herself. This A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EH9899), intramuscular at single dose in the left arm on 22Dec2020 09:00 for covid-19 immunisation. Medical history included reaction to pork, porsine and/or if she ever was exposed to exposed to heparin. There were no concomitant medications. On 23Dec2020, the patient experienced syncope (medically significant), dizziness (medically significant), feeling faint; like going to pass out now and then (medically significant), overall achiness, severe headaches, fever. The outcome of the events syncope, dizziness, feeling faint; like going to pass out now was recovering and outcome of overall achiness, severe headaches, fever was recovered on 24Dec2020. The patient ask: are there any animal products, pork gelatin or a lipid form of that contain in the vaccine? The events were described as follows: She experienced a significant amount of syncope and dizziness, for greater than 4 or 5 days post-receiving the vaccination. Also feeling faint like she is going to pass out every now and then. Has a more important question, wondering along with the doctors if one of the ingredients may have an animal product, like pork gelatin or a lipid form of that. It looks like one of the ingredients may have an animal cell lipid and was wondering if she was having a reaction to that. Declines to provide primary care provider details. States she received this first dose at occupational health in her workplace. Received the vaccine on the 22Dec2020 at 9am. 24 hours post vaccination, 1 day after, the syncope, dizziness, feeling faint started. Also the other symptoms, overall achiness, severe headaches, and fever were also experienced, but they stopped after that 24 hours. Those were expected since it was listed as side effects that popped up, so she expected those and they stopped after 24 hours. The syncope, dizziness, and faint feeling are not any worse and are very slowly improving, but she still has it and had to call out of work today because of it. That's consistent. Mentions it takes her a while to get down the stairs when getting product details for the COVID-19 vaccine. Unable to provide the vaccine NDC or expiry, or dose. Did not have any other vaccines at time of this one and none 4 weeks prior. Had to call a (company withheld) doctor and has to go to occupational health tomorrow to be seen. Declines having COVID virus. No further details provided.; Sender's Comments: Based on the compatible time association, the events syncope and dizziness are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 30 | 2021-01-04 | dizziness | Light headed |
| 30 | 2021-01-04 | chills, headache, fever, fatigue, dizziness |
Patient received vaccine on 12/17/2020 at approximately 12pm. At 10pm that day, patient developed ch...
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Patient received vaccine on 12/17/2020 at approximately 12pm. At 10pm that day, patient developed chills and fatigue. At 6am on 12/18/2020, patient developed fever (temperature 100.2) and a very sore arm. Patient took acetaminophen (Tylenol) at 6:30am for the fever and pain. By 1pm on 12/18/2020, patient reports headache and dizziness. Patient took Rizatriptan (Maxalt) for the headache and dizzy, but it did not help. Patient took ibuprofen at approximately 4pm. Patient felt normal at 5:30pm on 12/18/2020. Took Tylenol at 6:30 for the sore arm. Took Maxalt for the headache/dizziness (sometimes migraines make me dizzy, maxalt didn?t help). Took ibuprofen around 3-4ish? And felt fine by 5:30.
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| 30 | 2021-01-04 | dehydration | Severe nausea, vomiting, dehydration requiring IV hydration and antiemetics |
| 30 | 2021-01-04 | throat pain, malaise, fatigue |
Sore throat; not feeling well/general malaise; feeling tired/fatigue; Feeling achy; This is a sponta...
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Sore throat; not feeling well/general malaise; feeling tired/fatigue; Feeling achy; This is a spontaneous report from a contactable physician (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 11:00 single dose for preventive. Medical history included depression. Concomitant medication included duloxetine hydrochloride (CYMBALTA) for depression. The patient previously took flu vaccine for immunization. The patient received the Covid 19 vaccine on Wednesday. Patient stated there was a possibility of feeling achy just a general possibility of not feeling well like feeling tired, like it was she had that flu, vaccine too. But, her symptoms had persisted and she also had an isolated sore throat that started after she got her vaccine. She understood that the vaccine did not cause Covid but she was not sure like if having a sore throat was what other people have reported or this was something where she should go and get tested. Physician stated that question hadn't been answered by the previous department. When probed if the indication was a preventive measure for Covid, Physician stated "Preventive." Event (sore throat) started on 23Dec2020. The patient was given the vaccine at 11 am and her symptoms started probably at around 21:00 (9 pm). Patient further stated she received vaccine on 23Dec2020 around 11am and developed side effects of sore throat, fatigue/general malaise that evening. She couldn't find any data specifically reporting on sore throat. She was wondering if she should get tested for covid. Investigation assessment was no. The outcome of the events was unknown.
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| 30 | 2021-01-04 | headache |
headache; constipation; This is a spontaneous report from a contactable other HCP. A 30-year-old fem...
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headache; constipation; This is a spontaneous report from a contactable other HCP. A 30-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular in left arm on 23Dec2020 at a single dose for covid-19 vaccination. The vaccine was administered in the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient was not pregnant. On 24Dec2020, the patient experienced constipation and headache since vaccine (7 days). The outcome of the events was unknown. There was no treatment for the events. ON 24Dec2020, the patient had COVID test type post vaccination=Nasal Swab with a negative result. The events were assessed as non-serious.
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| 30 | 2021-01-05 | fatigue |
15 weeks today, healthy pregnancy, due date is June 30th. I had a lot of arm soreness and fatigue. F...
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15 weeks today, healthy pregnancy, due date is June 30th. I had a lot of arm soreness and fatigue. Felt like I could not get up or do anything.
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| 30 | 2021-01-05 | dizziness |
At approximately 1630, patient was getting ready to leave the vaccine clinic. She advised writer tha...
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At approximately 1630, patient was getting ready to leave the vaccine clinic. She advised writer that she had a strong metallic taste in her mouth. It started 10-15 minutes after the injection. Denied all other symptoms that could be considered a side effect or allergic reaction to the vaccination. Advised patient she could stay later for further observation. Patient declined to stay. She felt fine otherwise. Patient was further advised if develops shortness of breath, or throat tightening to call 911 immediatley. Patient verbalized understanding. She indicated that she does have an epi pen due to allergies and will use it if necessary. Called patient at approximately 1830. She informed writer that she did have the strong Metallic taste in her mouth that started 15 minutes after the immunization and it lasted for about 1 hour. She reports that she was slightly light headed once she got home. Patient is not sure if it is due to starting night shift last night or if it was from the vaccine. Patient encouraged to increase her water intake. She was also encouraged to call PCP's office if light headedness does not completely resolved. If develops life threatening symptoms, to call 911. She was in agreement with plan. Writer will completed VAERS report tomorrow.
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| 30 | 2021-01-05 | throat irritation, fatigue, headache |
Burning sensation in throat, mild color change in neck and chest- beginning around 8am lasting until...
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Burning sensation in throat, mild color change in neck and chest- beginning around 8am lasting until about 10am. Uncontrollable tremors, feeling like I need to constantly be moving and tachycardia- started around 830a started to diminish once I took a benadryl around 10a. Headache, fatigue and nausea beginning hours after vaccine, still present on 01/05. Sore arm at injection site and swollen axillary lymph node in same arm.
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| 30 | 2021-01-05 | fatigue |
Fatigue; Muscle soreness in the arms, neck, and upper back; This is a spontaneous report from a cont...
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Fatigue; Muscle soreness in the arms, neck, and upper back; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular on left arm on 16Dec2020 13:30 at single dose for COVID-19 immunization. Medical history included obstructed sleep apnea, chronic sinusitis, and obesity. The patient has no known allergies. There were no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at a hospital and the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experience muscle soreness in the arms, neck, and upper back as well as fatigue on 17Dec2020 12:00 (starting about 24 hours after the vaccination). The symptoms were resolved by the next day (Dec2020), or approximately 48 hours after the vaccination. No treatment was given for the events. Information about lot/batch has been requested.
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| 30 | 2021-01-05 | headache, fatigue | Headache fatigue, pain at injection site, mental fog |
| 30 | 2021-01-05 | fatigue, dizziness, migraine, fever |
Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fat...
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Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; This is a spontaneous report from a contactable Nurse (the patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL0140, expiration date unknown) via an unspecified route of administration on 29Dec2020 at 12:30 PM (at the age of 30-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. The patient's medical history was not reported. No information was reported regarding allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient answered "yes" when asked to list any other medications she had received within two weeks of vaccination but did not list those medications. The patient stated that she experienced lightheadedness on 29Dec2020 "immediately after vaccine." About twenty-four hours later, on 30Dec2020 at 13:00 she experienced "SEVERE" diarrhea/urgency, nausea, fatigue, fever of 101 and migraine. The patient did not receive any treatment for the events. The clinical outcomes of lightheadedness, severe diarrhea/urgency, nausea, fatigue, fever of 101 and migraine were reported as recovering. The patient underwent lab tests and procedures which included body temperature: 101 on 30Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19.
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| 30 | 2021-01-05 | chills, malaise | Pain in site of injection, malaise, chills, retro orbital pain for approximately 24h. |
| 30 | 2021-01-05 | dizziness |
Palpitations, elevated heart rate. Red Face. Red upper chest. Complained of lightheadedness and pre-...
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Palpitations, elevated heart rate. Red Face. Red upper chest. Complained of lightheadedness and pre-syncopal. HR radial 120 bpm, BP 145/91 with HR 111 with BP cuff. Able to be released, feeling better. Recheck of BP 137/84, HR 88 bpm.
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| 30 | 2021-01-05 | headache, chills, fever, fatigue | Rigors (4 hours), Fever to 101F (4 hours), muscle aches, fatigue, headache (ongoing) |
| 30 | 2021-01-05 | dizziness, dehydration, sweating |
severely dehydrated; sweaty; dizzy; This is a spontaneous report from a non-contactable consumer (pa...
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severely dehydrated; sweaty; dizzy; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration from 03Jan2021 14:30 to 03Jan2021 14:30 as single dose for COVID-19 immunization. Medical history included allergies to latex, psoriatic arthritis, asthma, migraines and COVID19 prior vaccination. The patient's concomitant medications were not reported. The patient previously took Vicodin, Codeine, Imitrex and experienced allergies. On 03Jan2021 15:00, the patient got severely dehydrated, sweaty, dizzy. The outcome of the events was recovered. The patient does not received treatment for the events. No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
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| 30 | 2021-01-06 | malaise |
12/26/2020 WOKE UP, STOMACH HURTING, DIARRHEA. MALAISE. CYCLE BETWEEN BOTH, ALL DAY. WENT TO ER SAM...
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12/26/2020 WOKE UP, STOMACH HURTING, DIARRHEA. MALAISE. CYCLE BETWEEN BOTH, ALL DAY. WENT TO ER SAME DAY; EVENING. COULD NOT GET A STOOL SAMPLE. VITALS WERE GOOD. ADMINISTERED IV FLUIDS. 12/27 STOMACH STILL HURTING BUT NOT AS SEVERE.
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| 30 | 2021-01-06 | malaise |
12/26/2020 DIARRHEA, MALAISE, SEVERE STOMACH PAINS. WENT TO ER. ADMINISTERED IV FLUIDS. 12/27/2020 ...
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12/26/2020 DIARRHEA, MALAISE, SEVERE STOMACH PAINS. WENT TO ER. ADMINISTERED IV FLUIDS. 12/27/2020 STARTED TO FEEL BETTER.
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| 30 | 2021-01-06 | fever, fatigue, chills | 13 hrs post vaccination started with fever (101), body aches and chills. Today just fatigue |
| 30 | 2021-01-06 | fever, fatigue | 13hrs post vaccination fever of 101, body aches,fatigue. today just fatigue |
| 30 | 2021-01-06 | fatigue, headache |
5 days after injection started a light headache. 6 days after injection joint pain, in hips and tail...
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5 days after injection started a light headache. 6 days after injection joint pain, in hips and tailbone. feeling fatigue, nausea. with decreased appetite. Night time of day 6 stomach cramps with diarrhea.
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| 30 | 2021-01-06 | chills, fever |
Chills and body aches, 30 hours Fever, 8 hours, max 101.7, Tylenol Soreness and injection site, 48 h...
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Chills and body aches, 30 hours Fever, 8 hours, max 101.7, Tylenol Soreness and injection site, 48 hours
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| 30 | 2021-01-06 | chills |
Chills, myalgias, rash to chest and ear that is pruritic (started day after the vaccine and continue...
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Chills, myalgias, rash to chest and ear that is pruritic (started day after the vaccine and continued to day 3 post vaccine). No signs of anaphylaxis.
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| 30 | 2021-01-06 | fever, chills |
Fever for 8 hours with max 101.7, Tylenol taken x2 doses Chills and body aches for 30 hours Sore arm...
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Fever for 8 hours with max 101.7, Tylenol taken x2 doses Chills and body aches for 30 hours Sore arm for 60 hours
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| 30 | 2021-01-06 | fatigue, headache |
For 48 hours following injection, mild to moderate injection site pain was experienced. 5 days after...
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For 48 hours following injection, mild to moderate injection site pain was experienced. 5 days after the injection, symptoms including headache, body aches, fatigue lasting 24 hours.
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| 30 | 2021-01-06 | chills, dehydration, fatigue, headache, malaise |
Headache back of neck, twmples and eyebrows, really sore injection site. Fatigue, Malase, nausea off...
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Headache back of neck, twmples and eyebrows, really sore injection site. Fatigue, Malase, nausea off and on, decreased appetite. Feeling dehydrated, chills/ at times painful sensitive skin similar to the flu. Muscle aches throughout the body.
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| 30 | 2021-01-06 | chills, headache | Headache, arm pain, and chill |
| 30 | 2021-01-06 | lethargy, fever, chills, headache |
Injection site pain; headache for 2 days; neck and lower back joint pain; neck and lower back joint ...
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Injection site pain; headache for 2 days; neck and lower back joint pain; neck and lower back joint pain; fever of 101; nausea; chills; neck and lower back joint pain; lethargy; This is a spontaneous report from a contactable Nurse (the patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899, expiration date unknown), intramuscularly, on 31Dec2020 at 07:30 (at the age of 30-years-old) an unspecified dose in the left arm for COVID-19 vaccination. Medical history included anxiety and depression from unknown dates. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 01:00 the patient experienced vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101 degrees, nausea, chills and lethargy. The patient did not receive any treatment for the events. The clinical outcomes of vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101degrees, nausea, chills and lethargy were reported as recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
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| 30 | 2021-01-06 | migraine |
Left sided Migraine that lasted 3 days. I took BC powder, Excedrin, and my regular prescribed migrai...
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Left sided Migraine that lasted 3 days. I took BC powder, Excedrin, and my regular prescribed migraine meds. Nothing helped, it was relentless. I am still having some pain but not as severe. I did not seek treatment as I hate the shots they used to do before my Topamax was prescribed. I had been migraine free for a little over year before this shot.
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| 30 | 2021-01-06 | fever, chills | Nausea, fever, chills, body aches |
| 30 | 2021-01-06 | fatigue, respiratory tract congestion, headache, chills |
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 17 hours post vaccination, I woke with moderate ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 17 hours post vaccination, I woke with moderate body aches, moderate headache, moderate congestion, mild chills (NO fever), mild nausea, and significant overall fatigue. Symptoms ongoing for 8 hours, however chills and nausea are gone.
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| 30 | 2021-01-06 | throat pain, dizziness | SORE THROAT, LIGHT HEADINESS; TREATMENT: GAVE 25MG OF DIPHENHYDRAMINE |
| 30 | 2021-01-06 | dizziness, fatigue |
Shortly after receiving the vaccine: lightheadedness lasting a few hours. The day after sore arm at ...
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Shortly after receiving the vaccine: lightheadedness lasting a few hours. The day after sore arm at the injection site. 3 days after until present: major fatigue.
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| 30 | 2021-01-06 | shortness of breath |
When patient presented to get immunization she reported previous mild reaction of hives with flu imm...
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When patient presented to get immunization she reported previous mild reaction of hives with flu immunization. She reported prior to receiving her flu immunization she would take 50mg diphenhydramine. We had her take 50mg diphenhydramine & then wait 30 minutes prior to receiving the first COVID-19 dose. After receiving the vaccine we had her stay in the room directly in front of us for 30 minutes so we could monitor her. It was noted she seemed to be having difficulty breathing & at that point we administered the first epinephrine 0.3mg dose. She reported feeling better & her color got better. We continued to closely monitor her & in approximately 7 to 8 minutes her breathing became labored again. A second epinephrine 0.3mg dose was administered & we called to have her transported to the hospital.
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| 30 | 2021-01-06 | fever | fever, body aches |
| 30 | 2021-01-06 | fever | fever, vomiting |
| 30 | 2021-01-06 | fatigue | muscle aches, confusion, fatigue, lymph nodes tenderness in underarms and jaw 1/7/20 |
| 30 | 2021-01-07 | fever, chills |
Developed palpitations and tachycardia with sustained HR in low 100?s (baseline is 55). Febrile to 1...
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Developed palpitations and tachycardia with sustained HR in low 100?s (baseline is 55). Febrile to 103, chills, rigors, nausea/vomiting.
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| 30 | 2021-01-07 | fatigue, chills, headache | Fatigue, body aches, chills, very sore site extremity all last about 24 hours, rigid neck, headache |
| 30 | 2021-01-07 | headache, fever, chills | Fever, chills, muscle and joint pain, headache; improved with ibuprofen |
| 30 | 2021-01-07 | fever, fatigue |
Fever; aches; fatigue; injection site soreness for 5 days; loss of appetite; This is a spontaneous r...
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Fever; aches; fatigue; injection site soreness for 5 days; loss of appetite; This is a spontaneous report from a contactable healthcare professional. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), intramuscular on left arm on 18Dec2020 16:30 at a single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medication included birth control medication (unspecified) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior to vaccination, patient was not diagnosed with Covid-19. On 19Dec2020 at 09:00 AM, patient experienced fever, aches, fatigue, injection site soreness for 5 days and loss of appetite. No treatment was received for the reported adverse events. Since the vaccination, the patient has not been tested for Covid-19. The outcome of the events was recovered. Information about lot/batch number has been requested.
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| 30 | 2021-01-07 | headache, sweating, malaise |
Generalized body aches, malaise, tachycardia, nausea, headache, sweats. Intermittently for 48 hours,...
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Generalized body aches, malaise, tachycardia, nausea, headache, sweats. Intermittently for 48 hours, worse at night.
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| 30 | 2021-01-07 | headache | Headache, pain and warmth of injection site, and strange dreams |
| 30 | 2021-01-07 | fatigue, fever |
Low grade fever; Tingling face and tongue; Muscle aches; Fatigue; This is a spontaneous report from ...
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Low grade fever; Tingling face and tongue; Muscle aches; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, intramuscular on left arm on 02Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included fibromyalgia. The patient was not pregnant. Patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced low grade fever, tingling face and tongue, muscle aches, and fatigue, all on 03Jan2021 06:00. The events were reported as non-serious. Patient was not diagnosed with COVID-19 and has not been tested for COVID-19 prior to vaccination. Outcome of the events was recovering. Information on the Lot/Batch Number has been requested.
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| 30 | 2021-01-07 | fatigue, chills |
Mild chills - onset 8-12 hours after Body aches - onset 8-12 hours after Fatigue - onset 8-12 hours...
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Mild chills - onset 8-12 hours after Body aches - onset 8-12 hours after Fatigue - onset 8-12 hours after
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| 30 | 2021-01-07 | headache, fatigue, chills, fever, sweating |
Over night on 01/06 I experienced chills and was very cold. At times I was extremely warm. The next ...
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Over night on 01/06 I experienced chills and was very cold. At times I was extremely warm. The next morning I had a fever and my joints, muscles, head and even my skin was hurting. My fever never came down to normal even with advil and I was extremely tired all day. The arm that had the injection is extremely sore with splotches of red (which is expected.) Today, 01/08, I woke up in a pool of sweat. My head is still hurting and I still have a fever. My arm is still sore but my skin and joint pain has improved. I am still very cold. Have been wearing my winter coat in my house even with the heat and the fire place on. I had to take the last two days off work.
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| 30 | 2021-01-07 | dizziness |
Patient received the Covid-19 vaccine. 10 min after the vaccine she reported a feeling that her hear...
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Patient received the Covid-19 vaccine. 10 min after the vaccine she reported a feeling that her heart was racing, felt light headed, no throat tightness. Her initial b/p was 150/95 HR 145 sao2 100% Slightly pale in appearance. After about 5 minutes she reported feeling better, she drank water, ate pretzels. She was observed to a total of 30 minutes. Recheck of her B/P 144/80 HR 76 100 % sao2 . Pt left on her own accord Ambulatory. She will follow up in the ED if her symptoms return or for any concerns.
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| 30 | 2021-01-07 | fatigue, headache, influenza like illness, fever, chills |
Severe flu like symptoms, fever over 101, chills, body aches, headache, nausea/loss of appetite, fat...
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Severe flu like symptoms, fever over 101, chills, body aches, headache, nausea/loss of appetite, fatigue, soreness in the arm from injection
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| 30 | 2021-01-07 | headache, somnolence |
Soreness at the site about 3 hours after the injection followed by headache about 24 hours after. Th...
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Soreness at the site about 3 hours after the injection followed by headache about 24 hours after. Then about 48 hours after, developed diffuse myalgia and drowsiness
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| 30 | 2021-01-07 | fatigue |
a little fatigue; minor body aches; her arm was a little sore; This is a spontaneous report from a c...
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a little fatigue; minor body aches; her arm was a little sore; This is a spontaneous report from a contactable nurse . A 4-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Was notified on 04Jan2021 while the reporter scrolling on Facebook a friend of her who is a nurse who got the Pfizer COVID-19 vaccine and had side effects. Someone on had asked if the patient had any affects, patient stated a little fatigue and minor body aches. The reporter went back to and took a screenshot of the post that was dated from 23Dec2020. Patient was in her late 30's. Patient received vaccine on 23Dec2020 and she worked at Hospital name. This then triggered her to look into her other nurse friends. Apologizes for not having much information to provide on patient, she hasn't spoken to patient in 6 years. Mentioned that post only mentioned her arm was a little sore, but that was with any vaccine. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 30 | 2021-01-07 | dizziness, throat swelling, throat pain, fatigue |
light headed, sore throat, swollen throat, body and muscle aches and fatigue, encouraged to seek med...
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light headed, sore throat, swollen throat, body and muscle aches and fatigue, encouraged to seek medical attention.
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| 30 | 2021-01-07 | shortness of breath |
palpitations; shortness of breath; ears burning; This is a spontaneous report from a contactable phy...
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palpitations; shortness of breath; ears burning; This is a spontaneous report from a contactable physician. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04Jan2021 08:00 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced palpitations on 04Jan2021 08:00, shortness of breath on 04Jan2021 08:00, ears burning on 04Jan2021 08:00. All events were nonserious. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No treatment was received. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. the patient has not been tested for COVID-19 since the vaccination. No allergies to medications, food, or other products. The outcome of the events was resolved in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 30 | 2021-01-07 | headache, weakness, cough, shortness of breath, fatigue |
shortness of breath/progressed until I went to urgent care; I started to really bad cough and then i...
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shortness of breath/progressed until I went to urgent care; I started to really bad cough and then it actually got worse and worse; I was so weak like I am breastfeeding, I couldn't even hold my baby; extreme fatigue; I couldn't stay awake for more than a few hours at a time; Headache; lung problem; This is a spontaneous report from a contactable physician (the patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EH9899, via an unspecified route of administration on 16Dec2020 13:00 at single dose for COVID-19 immunisation. Medical history included history of reaction to mango (like face swelling and just a rash) and then gluten intolerant: if she eat it she doesn't have difficulty breathing. She never had problems with asthma in the past. The patient previously took BENADRYL for shortened like when she had a reaction with mango many years ago. In the past the patient had problems with cold and problems having bad cough that linger but she never needed Albuterol or steroids before. The patient had flu vaccine a month before, administered in deltoid left. The patient's concomitant medications were not reported. The patient experienced extreme fatigue on 19Dec2020 with outcome of recovering, shortness of breath/progressed until she went to urgent care on 21Dec2020 with outcome of recovering, She started to really bad cough and then it actually got worse and worse on 21Dec2020 with outcome of recovering, She was so weak like she was breastfeeding/She couldn't even hold her baby on 19Dec2020 with outcome of recovered on 20Dec2020, She couldn't stay awake for more than a few hours at a time on Dec2020 with outcome of unknown, headache on Dec2020 with outcome of unknown, lung problems on Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included chest x-ray: normal on unspecified date; SARS-COV-2 test: negative on 23Dec2020. The vaccine was administered at Hospital Facility. The patient was treated with steroids (20mg for 5 days) and an albuterol inhaler (2 puff every 4 hour). The events required visit to Emergency Room. The events were non serious.
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| 30 | 2021-01-08 | nasopharyngitis, fatigue, body temperature increased, chills, headache |
3am woke up freezing cold and shivering. Temp 99.7. 4:30am temp was 101.3. Took 975mg Tylenol. 8:00a...
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3am woke up freezing cold and shivering. Temp 99.7. 4:30am temp was 101.3. Took 975mg Tylenol. 8:00am fever broke. Headache. Took more Tylenol 2:00pm headache. Took migraine medication. Laid down to sleep. 5:30pm woke up. Temp 100.7. Took 650mg Tylenol. 8pm fever broke. Headache better. *fatigue and soreness at injection site all day* Saturday 1/9/21 Feeling much better. No fever or headache so far. 11:30am.
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| 30 | 2021-01-08 | dizziness, headache | Dizziness, increased heart rate, feeling like fainting, and headache. |
| 30 | 2021-01-08 | chills, sweating, headache |
Headache and body pain beginning following morning, progressive throughout day adding chills/sweats ...
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Headache and body pain beginning following morning, progressive throughout day adding chills/sweats by 2pm which resolved by about 10 pm. Residual minor headache next day
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| 30 | 2021-01-08 | fever, chills |
Immediately after getting the vaccine my left arm was sore, which became worse in the evening, causi...
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Immediately after getting the vaccine my left arm was sore, which became worse in the evening, causing me pain to raise my left arm. Around 5 pm the same day, I started having body aches and had the chills. Then around 8pm I spiked a fever which reached up to 102.0 Fahrenheit, which I treated with Tylenol. In the morning (1/9/2021) the fever returned at 101.2 Fahrenheit, which I treated with Tylenol again.
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| 30 | 2021-01-08 | chills, fever |
Neck pain, chills, high fever, joint pain for 72hrs nausea, abd. cramping (48 hrs post vaccine) pers...
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Neck pain, chills, high fever, joint pain for 72hrs nausea, abd. cramping (48 hrs post vaccine) persistent symptoms lasting 5 days after COVID vaccine Cervical & submandibular lymph adenopathy
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| 30 | 2021-01-08 | shortness of breath, dizziness |
Tingling hands, difficulty breathing, face felling hot and swollen - started almost immediately afte...
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Tingling hands, difficulty breathing, face felling hot and swollen - started almost immediately after injection. Benadryl was given and EMT advised going to the hospital for observation. Heart rate and bp returned to normal a few hours later. Still feel dizzy and lightheaded when standing. Was informed that it was a vasovagal reaction. Arm is also very sorry at injection sight. Left arm where injection was placed it still tingling in hand, right hand feels normal.
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| 30 | 2021-01-08 | headache, fatigue |
severe body aches, swollen and painful lymph nodes in both armpits and bilateral neck, achy joints a...
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severe body aches, swollen and painful lymph nodes in both armpits and bilateral neck, achy joints and muscles, headache, achy eyes, extreme tiredness, itchy all over and swollen, painful and itchy injection site.
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| 30 | 2021-01-09 | chills, fever, malaise |
About 12 hours of receiving my second dose I started to get really bad chills. Nothing could keep me...
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About 12 hours of receiving my second dose I started to get really bad chills. Nothing could keep me warm and I had a fever of 102. I had muscle aches as if I just went through a rigorous workout. I had zero appetite but I?m not sure if that was due to side effects or the fact that I wasn?t feeling well. When I did finally eat something that evening I could barely taste it, I ate it but my taste buds were faintly picking up the flavors. Again I don?t know if it was because of the side effects or the fact that I wasn?t feeling well. The following day, Saturday 01/09/21 I only had chills which would come and go. I did not have fever and my appetite was back. Now today, 01/10/21 I feel my usual self.
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| 30 | 2021-01-09 | fever, headache, chills |
At 8 am on Friday morning, about 14 hours after I received my 2nd dose of Pfizer covid vaccine, I ha...
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At 8 am on Friday morning, about 14 hours after I received my 2nd dose of Pfizer covid vaccine, I had muscle soreness and aching. I went home and slept after working night shift. I woke up at 11 am, 17 hours post vaccine, and had a 102.4 F fever, chills, body aches and headache. At 3pm I still had 102-103F fever and called employee health and in which was directed to take Tylenol or Advil. I took 600mg Advil, and my fever broke at 8 pm, 26 hours post vaccine. That night my fever returned 102-103 F, I continued to take Advil. I took Advil around the clock, but let it lapse in dose Saturday evening 50 hours after receiving my vaccine. I then had a 101.5 F temp, I waited and it continued to rise, at midnight tonight, 30 mins ago, I took 600 mg Advil
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| 30 | 2021-01-09 | fever, fatigue, chills | Chills, Fever (103.6), body aches, fatigue |
| 30 | 2021-01-09 | headache |
Patient felt HR elevating, then c/o headache, tachycardia. Monitored closly (see sheet for V.S. etc...
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Patient felt HR elevating, then c/o headache, tachycardia. Monitored closly (see sheet for V.S. etc.) Benadryl 25 mg. by mouth. 7:42 Stable, discharged at 07:42 to self.
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| 30 | 2021-01-09 | headache | Pfizer-BioNTech COVID-19 Vaccine EUA Headache without fever, 3 days, treated with acetaminophen |
| 30 | 2021-01-09 | fever, chills, headache, fatigue | Sore and swollen arm at injection site, headache, fatigue, fever, chills |
| 30 | 2021-01-09 | fever, chills |
The day after I received the second dose, I experienced arthralgia, chills, fever, and muscle aches....
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The day after I received the second dose, I experienced arthralgia, chills, fever, and muscle aches. The second day after the vaccine, those symptoms were much relieved.
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| 30 | 2021-01-10 | fever, chills, headache |
About 14 hours post getting the second dose I started having chills and rigor and ended up having a ...
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About 14 hours post getting the second dose I started having chills and rigor and ended up having a fever of 100.5 degrees fareinheight, took 1 gram Tylenol, fever broke, 4 hours later I had rigor and chills again and was febrile again, and took ibuprofen. I also felt nauseous and have a headache.
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| 30 | 2021-01-10 | fatigue, headache |
Arm soreness- mild, 2 days Headache - mil, 20-60 minutes Diarrhea - mild, 1 day Fatigue - mild, .5...
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Arm soreness- mild, 2 days Headache - mil, 20-60 minutes Diarrhea - mild, 1 day Fatigue - mild, .5 day
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| 30 | 2021-01-10 | fatigue, chills, dizziness |
At 3 am the next day after my vaccine (sat the 9th)I woke up to all my joints burning, like they wer...
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At 3 am the next day after my vaccine (sat the 9th)I woke up to all my joints burning, like they were on fire. The next morning I had chills, severe joint pain, fatigue, dizziness, nausea, and rash/ redness on my face (cheeks, nose, forehead). The next day (Sunday, the 10th) I felt much better but still a bit of joint pain and fatigue. Today (Monday the 11th) I felt fatigued, with. A resting heart rate of 90 according to my fitbit. I had some numbness/tingling in my right arm, dizziness, and felt fatigued. Towards the end of today I felt better but still have some pain in lower back and neck.
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| 30 | 2021-01-10 | dizziness | Became lightheaded and dizzy , syncopal.VSS, MD assessed and transported to Clinic for observation |
| 30 | 2021-01-10 | headache, fatigue |
Fatigue, muscle aches, joint paint, slight headache beginning early morning on 1/9/2021. Chest pain...
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Fatigue, muscle aches, joint paint, slight headache beginning early morning on 1/9/2021. Chest pain from 9pm 1/9/2021 to 2am on 1/10/2021. Symptoms resolved without any interventions.
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| 30 | 2021-01-10 | headache, fever | Fever, Body aches, Headache |
| 30 | 2021-01-10 | dizziness, lethargy |
Immediate numbness on top of left hand, tachycardia, flushing, dizziness, dry/numb mouth, feeling fa...
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Immediate numbness on top of left hand, tachycardia, flushing, dizziness, dry/numb mouth, feeling faint, lethargy. Was wheeled to ED where they left me in the waiting room for two hours, not seen by a provider, before being told I was "fine" and sent home. On 1/9/2020 I began experiencing widespread bodily itch, no hives or swelling that included in and around my mouth. Took cirtirizine and symptoms were alleviated.
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| 30 | 2021-01-10 | chills |
Pain at injection site, constant, began ~2 hours after vaccine administration-time of VAERS submissi...
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Pain at injection site, constant, began ~2 hours after vaccine administration-time of VAERS submission Chills, duration from 3 AM-5 AM on 1/11/2020 ~14 hours after vaccine administration Generalized muscle aches, constant, began at 6 AM on 1/11/2020 - time of VAERS submission, ~ 17 hours after vaccine administration
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| 30 | 2021-01-10 | chills, headache | Severe head ache; nausea/vomiting; chills; muscle aches; injection site pain and swelling |
| 30 | 2021-01-10 | fatigue |
Slight pain at the injection site; sore/tender muscles on the left side of the body (mainly shoulder...
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Slight pain at the injection site; sore/tender muscles on the left side of the body (mainly shoulder & neck); soreness/stiffness in left hip; soreness/stiffness in left hip; fatigue; This is a spontaneous report from a contactable pharmacist, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL1284) solution for injection intramuscular in the left arm on 31Dec2020 at 12:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no relevant medical history. There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01Jan2021, the patient experienced slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue. No treatment was provided for the events slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue. The outcome of the events slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
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| 30 | 2021-01-10 | malaise |
Strong pain throughout my body. Stronger pain in lower back and neck. Fatigue and tiredness. Stomach...
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Strong pain throughout my body. Stronger pain in lower back and neck. Fatigue and tiredness. Stomach malaise
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| 30 | 2021-01-10 | dizziness, cold sweat, chills |
Within seconds of vaccine administration, I felt flushing of my upper and lower extremities as well ...
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Within seconds of vaccine administration, I felt flushing of my upper and lower extremities as well as muffling in my right ear. My hands and feet became clammy. A small fan helped subside symptoms momentarily. Within minutes my lower extremities became shaky. I developed chills and felt faint. VS were measured. I was hypertensive (BP 134/100, baseline BP usually runs 110/80s). I developed intermittent tachycardic and heart palpitations, with a max HR of 124. Symptoms lasted approximately 1hour post vaccine administration. I work at a COVID testing site, chances of me being exposed to COVID-19 are high. I was not tested prior to receiving either dose of the vaccine; however, I have remained asymptomatic for the duration of the series.
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| 30 | 2021-01-10 | headache, dizziness, chills | body aches, chills, dizziness, headache. Improving. |
| 30 | 2021-01-10 | fever | fever of 100.9, swollen lymph nodes, body aches, joint pain |
| 30 | 2021-01-10 | fever | fever up to 102 body aches arm pain |
| 30 | 2021-01-10 | headache, fatigue | headache, fatigue |
| 30 | 2021-01-11 | fever, chills, headache |
12 hours after vaccination: Uncontrollable Rigors, muscle contractions, fever, chills, hyperesthesia...
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12 hours after vaccination: Uncontrollable Rigors, muscle contractions, fever, chills, hyperesthesia, abdominal pain, nausea, headache, back pain
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| 30 | 2021-01-11 | shortness of breath |
20 minutes after dose pt experienced some chest tightness, trouble breathing, and headache. Patient ...
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20 minutes after dose pt experienced some chest tightness, trouble breathing, and headache. Patient was still talking so gave her 50mg Benadryl and ice water, had her sit down and continue drinking water for another 30 minutes. 30 minutes after Benadryl was given patient's symptoms subsided.
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| 30 | 2021-01-11 | shortness of breath, dizziness |
3-5 mins after receiving, developed tachycardia, shortness of breath, dizziness, and nausea. Improve...
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3-5 mins after receiving, developed tachycardia, shortness of breath, dizziness, and nausea. Improved within 2-3 mins, cleared within 5-10 mins. No further reaction.
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| 30 | 2021-01-11 | chills, fatigue, body temperature increased |
Approximately 15 hours after vaccine, developed muscle aches, chills., elevated Temperature to 99.2 ...
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Approximately 15 hours after vaccine, developed muscle aches, chills., elevated Temperature to 99.2 F. No true fever. Muscle aches, fatigue, and chills persisted for approximately 24 hours. All moderate intensity and with some response to tylenol/advil as needed. At 40 hours post vaccine, no remaining symptoms
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| 30 | 2021-01-11 | dizziness, headache | Body aches, HA, dizzy, back/neck/ aches |
| 30 | 2021-01-11 | fever | Developed fever and nausea after vaccine. unable to work the day after vaccine |
| 30 | 2021-01-11 | malaise, fever, chills, fatigue, headache |
Fever, body aches, chills, joint pain, headache, felling inwell, fatigued, sore arm all started 12/2...
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Fever, body aches, chills, joint pain, headache, felling inwell, fatigued, sore arm all started 12/28/2020 at 2100. Took cold/flu medicine
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| 30 | 2021-01-11 | fever, fatigue, headache | Headache, body ache, fever, fatigue. Improving. |
| 30 | 2021-01-11 | fever, chills, malaise, headache | Malaise, fever, chills, headache, body aches |
| 30 | 2021-01-11 | headache, fatigue | Muscle aches, headaches and fatigue |
| 30 | 2021-01-11 | malaise, migraine, headache |
Nausea; Feeling unwell; 1st dose Pfizer covid vaccine administered on 17Dec2020/second shot of the P...
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Nausea; Feeling unwell; 1st dose Pfizer covid vaccine administered on 17Dec2020/second shot of the Pfizer Covid vaccine yesterday (04Jan2021); back pain/back pain was pretty severe and was worse than it would normally be; severe headache that turned into a migraine; severe headache that turned into a migraine; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: Apr2021) intramuscular at left deltoid on 04Jan2021 16:00 at single dose for covid-19 immunisation. 1st dose Pfizer covid vaccine was administered on 17Dec2020 (Lot number: EH9899). She was covid positive the day after receiving her first dose of the Pfizer covid vaccine. Her primary care informed her to get the booster despite testing positive for the virus. She was told since she was asymptomatic that she could get the vaccine. Medical history included back pain, covid from 3 weeks ago (Dec2020). There were no concomitant medications. The patient experienced back pain and severe headache that turned into a migraine on 04Jan2021, nausea and feeling unwell on 05Jan2021. She got the second shot of the Pfizer Covid vaccine yesterday (04Jan2021) around 16:00. Overnight she had back pain, severe headache that turned into a migraine. Now she had developed nausea and was generally feeling unwell. She had covid 3 weeks ago and she was instructed to get the vaccine. She has a history of back pain but states it was obviously triggered. Reports that last night her back pain was pretty severe and was worse than it would normally be. Nausea and feeling unwell was reported as worsened. Back pain was slightly improved. Headache that turned into migraine improved with medication. The outcome of events back pain and severe headache that turned into a migraine was recovering; of events nausea and feeling unwell was not recovered.
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| 30 | 2021-01-11 | chills, fever, fatigue |
Rigors; Feverish (yet afebrile); Myalgias; Fatigue; This is a spontaneous report from a non-contacta...
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Rigors; Feverish (yet afebrile); Myalgias; Fatigue; This is a spontaneous report from a non-contactable consumer (patient herself). This 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date at single dose; and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 at single dose, for COVID-19 immunisation. Vaccine location was right arm. The patient did not have a relevant medical history. No known allergies. No relevant concomitant medications were provided. No other vaccine was received in four weeks. On unknown date, the patient developed rigors, feverish (yet afebrile), myalgias, and fatigue. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was not treated for the events. She recovered from the events on unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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| 30 | 2021-01-11 | chills, headache, fever | That night I had the chills, a fever of 101 and the worst headache |
| 30 | 2021-01-11 | dizziness | Vertigo sx, dizziness, tinnitus , sx are improving. |
| 30 | 2021-01-11 | dizziness, fatigue, headache, chills, fever, migraine |
Vomiting and inability to eat or retain food, swollen/painful arm lasting 4 days, hard welt/ball lik...
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Vomiting and inability to eat or retain food, swollen/painful arm lasting 4 days, hard welt/ball like swelling at peak of swelling beginning Thursday evening through Saturday, inability to raise, hold, grasp or use arm for 2 days after injection, consistent fever for 36 hours/intermittent fever through Saturday, tightness in chest (relieved with inhaler every 2 hours) for 36 hours, tingling and phantom pain along left side of body and face, excessive exhaustion, dizziness and unfocused thoughts 48 hours, persistent migraine for 36 hours, intermittent headaches continuing with chills and nausea. Worse symptoms were 24-72 hours after injection, more mild side-effects (intermittent headache, nausea and chills) continuing through today.
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| 30 | 2021-01-11 | headache, chills |
aches; Chills; Headache; tight muscles; Hot flashes; Next 2 days: soreness in left arm; This is a sp...
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aches; Chills; Headache; tight muscles; Hot flashes; Next 2 days: soreness in left arm; This is a spontaneous report from a contactable Other HCP (patient). This 30-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK5730) intramuscular at left arm on 03Jan2021 at 10:30 AM at single dose for COVID-19 immunisation. Medical history was unknown. Concomitant medications included cyclobenzaprine, levothyroxine and drospirenone/ethinylestradiol (NIKKI). The patient experienced aches and chills, headache and tight muscles on 03Jan2021 at 13:00. Then the patient had hot flashes and soreness in left arm from 03Jan2021 next 2 days. No treatment was received. The patient had no allergies to medications, food, or other products. The patient was no pregnant. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of all events was recovered.
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| 30 | 2021-01-11 | fatigue, headache | muscle aches, headache and fatigue |
| 30 | 2021-01-11 | headache |
severe headache for 72 hours bump beginning under skin 24 hours after injection, small bumps under t...
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severe headache for 72 hours bump beginning under skin 24 hours after injection, small bumps under the surface appear 72 hours later, today (1/12) bumps appearing around injection site
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| 30 | 2021-01-11 | chills, respiratory tract congestion, headache |
within 6 hours experienced severe chills and covid-like symptoms, she also tested positive for COVID...
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within 6 hours experienced severe chills and covid-like symptoms, she also tested positive for COVID-19; within 6 hours experienced severe chills and covid-like symptoms, she also tested positive for COVID-19; This is a spontaneous report from a contactable nurse. A 30-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left arm on 04Jan2021 11:30 at a single dose for COVID-19 vaccination. Medical history included allergies to Sulfa diagnosed in 2008, Allergies to Strawberries diagnosed when she was very young, Diamox allergy diagnosed in 2008, dyslexic, and Obesity but never been treated. Concomitant medication included levothyroxine (LEVOTHYROXINE), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), zinc (ZINC), nd cetirizine hydrochloride (ZYRTEC). The patient previously took diamox [acetazolamide] and experienced drug hypersensitivity. Patient received first dose Monday, 04Jan2021, then she experienced severe chills and Covid like symptoms. Apparently, she tested positive for COVID 19. She ws not sure if it was a false positive or if she actually has COVID, but was concerned because her husband has cancer and was immunocompromised. Literally, she got the vaccine because her OB/GYN told her she needs to get it as soon as possible. She did blood work and she tested negative for pregnancy. There was no prescriber as it was given as part of her work. Fifteen minutes after receiving the vaccine, she had the worst headache she has ever had in her life. Six hours after that, she had such bad chills. That night, it worsened and it got better every hour when she took something. She said her congestion was still present. She stated she took Tylenol and hour later and it subsided. The outcome of the events was not recovered. The patient underwent laboratory date including negative antibodies on an unknown date, blood work on Mar2020 with unknown result, then on 05Jan2020 tested positive to COVID 19 by saliva test at 09:15 and nasal test at 11:30 Information about Lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available
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| 30 | 2021-01-12 | malaise, chills, fatigue, fever |
1/7/21: Sore arm the night of the vaccine. 1/8/21: Woke-up around 4am with chills. Fever of 101.4 ar...
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1/7/21: Sore arm the night of the vaccine. 1/8/21: Woke-up around 4am with chills. Fever of 101.4 around 7am with generalized malaise and severe fatigue. Spent most of the day in bed. Fevers on and off throughout the day with Tmax of 101.4. Some mild body aches. Sore arm with itching at the injection site. Lump at injection site. Had to call off of work. Loss of appetite. 1/9/21: Afebrile the whole day. Moderate fatigue in the morning. Overall felt better by the afternoon. Sore arm continued with itching and lump remaining at the injection site. 1/10/21: Overall felt better, arm soreness and itching at injection improving. 1/11/21: Mild fatigue. No arm soreness. Itching improved. Lump at injection site improving. Mild body aches in the evening. 1/12/21: Mild fatigue. 1/13/21: No arm soreness, itching and lump at injection site gone.
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| 30 | 2021-01-12 | throat irritation |
11 minutes after vaccine this employee developed a metallic taste in her mouth, tachycardia and hive...
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11 minutes after vaccine this employee developed a metallic taste in her mouth, tachycardia and hives on her chest and neck. She reports her heart rate normalized quickly. Before she went to bed, she felt her tongue slightly swell and developed a scratchy throat. She reports the top portion of her throat feeling swollen as well. Benadryl resolved the symptoms.
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| 30 | 2021-01-12 | chills, fever, headache |
1st shot: sore arm 2nd shot: woke up the next morning with a low grade fever, headache, chills and b...
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1st shot: sore arm 2nd shot: woke up the next morning with a low grade fever, headache, chills and body aches
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| 30 | 2021-01-12 | chills, fever, fatigue |
2pm fatigue, soreness in arm 11pm nausea, vomiting, chills 12pm insomnia, fever, chills, body aches,...
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2pm fatigue, soreness in arm 11pm nausea, vomiting, chills 12pm insomnia, fever, chills, body aches, joint pain 2am continued fever despite fever reducers 6am (day after) continued fatigue, arm soreness reduced 12pm continued low grade fever -99.6-100, fatigue 6pm continued low grade fever, fatigue 6am (2 days after) improvement in symptoms 12pm return of low grade fever, and fatigue. continued soreness in arm
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| 30 | 2021-01-12 | headache, chills |
Beginning 12 hours after vaccine experienced chills, aches, nausea and headache. Also experiencing p...
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Beginning 12 hours after vaccine experienced chills, aches, nausea and headache. Also experiencing pain and swelling at injection site.
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| 30 | 2021-01-12 | chills, fatigue | Body aches, chills, fatigue |
| 30 | 2021-01-12 | dizziness, fatigue, chills |
Chills, body aches, joint pain, fatigue, dizziness. I took ibuprofen 400mg q6 with minimal effect. I...
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Chills, body aches, joint pain, fatigue, dizziness. I took ibuprofen 400mg q6 with minimal effect. I felt much better by my second day after the vaccine but still with fatigue, dizziness and joint pain. By the third day after I felt back to normal.
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| 30 | 2021-01-12 | fever, fatigue | Extreme fatigue 101 degree fever Body aches |
| 30 | 2021-01-12 | fever, chills |
Fever for 8 hours, max 101.7; Chills; body aches; Injection site pain; female patient who just got t...
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Fever for 8 hours, max 101.7; Chills; body aches; Injection site pain; female patient who just got the COVID vaccine and is currently breastfeeding; female patient who just got the COVID vaccine and is currently breastfeeding; This is a spontaneous report from a contactable nurse (patient). This nurse reported for both mother and baby. This is maternal report. A 30-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: Elt9899; expiration date: not known), via an unspecified route of administration on left arm on 19Dec2020 10:00 at single dose for covid-19 immunization, administered at workplace clinic. Medical history included childbirth in Jul2020 and currently (ongoing) breastfeeding. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included norethindrone (NORETHINDRONE [NORETHISTERONE]) and unspecified prenatal vitamin (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested with covid-19 since the vaccination. On 19Dec2020 10:00, the female patient who just got the COVID vaccine and is currently breastfeeding. On 19Dec2020 18:00, the patient experienced fever for 8 hours, max 101.7; chills and body aches for 30 hours; and injection site pain for 48 hours. The reported events were non-serious. There was no treatment received for the events fever, chills, body aches, and injection site pain. The outcome of the event 'fever' was recovered on 20Dec2020 02:00 (for 8 hours), of event "chills and body aches" was recovered on 21Dec2020 00:00 (for 30 hours), and of event "injection site pain" was recovered on 21Dec2020 18:00 (for 48 hours).; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021011500 baby case
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| 30 | 2021-01-12 | headache, fatigue | Headache, fatigue and nausea. No treatment and no improvement. Recommend patient get tested for flu. |
| 30 | 2021-01-12 | headache | Headache, neck pain. Starting day 2 until day 4 |
| 30 | 2021-01-12 | weakness |
I developed mild injection site pain about 5 minutes after the second dose which didn?t happen the f...
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I developed mild injection site pain about 5 minutes after the second dose which didn?t happen the first time so quickly. It shortly progressed to a cold/numb sensation from my deltoid down to my finger tips. This persisted but seemed to transition from more numbness to moderate pain from my left scapula, neck and down to my fingers about 7 hours after the vaccine. I also developed intermittent fasiculations of my forearm muscles on the left arm. This morning I woke up with worsening pain, mild numbness but new weakness in the hand and arm. I have a weak grip and can?t fully grab objects. My wrist flexión and extension are also weak as well as shoulder abduction (I am a neurologist by the way so can?t localize it to any nerve distribution). I?m not weak anywhere else and I only have mild arthralgia and diarrhea systemically.
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| 30 | 2021-01-12 | fatigue |
Initial injection site reaction (swelling and redness) began in 24 hours and resolved after 3 days. ...
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Initial injection site reaction (swelling and redness) began in 24 hours and resolved after 3 days. A secondary injection site reaction (redness and itching with minor swelling) began 10 days after injection and was almost resolved by 15 days after injection. Fatigue occurred 12 hours after injection and resolved in 3 days
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| 30 | 2021-01-12 | fever, chills, fatigue |
Pfizer-BioNTech COVID-19 Vaccine EUA Fatigue and arm soreness within a few hours turned into full b...
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Pfizer-BioNTech COVID-19 Vaccine EUA Fatigue and arm soreness within a few hours turned into full body chills, aches, and a fever about 8hrs after injection. Symptoms were intense and lasted throughout the night with Tylenol only minimally reducing fever. All symptoms lasted for about 24hrs, after which I felt completely normal.
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| 30 | 2021-01-12 | chills | Severe chills, muscle ache, joint aches. |
| 30 | 2021-01-12 | headache, fever, fatigue, chills |
The initial shot wasn't bad. Sore arm within 5 hours. That's all I had, until Thursday evening at 6....
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The initial shot wasn't bad. Sore arm within 5 hours. That's all I had, until Thursday evening at 6. Overwhelmed with exhaustion and fatigue. Massive headache coinciding. My arm felt like I had tennis elbow and overall joint pain. Nausea and vomiting through the night. Went to bed about 9:30. Woke up with a fever of 99. Off and on fever and chills through Friday, 72 hours after initial injection. Finally resolved late Friday night.
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| 30 | 2021-01-12 | fatigue, fever, chills |
chills; Tiredness; generalized body aches; fever 101.4; This is a spontaneous report from a contacta...
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chills; Tiredness; generalized body aches; fever 101.4; This is a spontaneous report from a contactable Nurse (patient). A 30-year-old non-pregnant patient female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1686),intramuscular at Right arm on 06Jan2021 08:15 at single dose for COVID-19 immunization. Facility type vaccine was Hospital. Medical history included covid-19 prior vaccination. Concomitant medication included levothyroxine and multivitamin. The patient experienced tiredness, generalized body aches, chills, fever 101.4 on 06Jan2021 20:00. No treatment received. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 30 | 2021-01-12 | chills, fever, sweating |
moderate chills, body aches, sweats, fever measured at 100.7F: occurred about 12 hours after injecti...
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moderate chills, body aches, sweats, fever measured at 100.7F: occurred about 12 hours after injection and lasted 8-10 hours
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| 30 | 2021-01-12 | nasal congestion, fever, nasopharyngitis, headache |
stuffed nose/stuffed up nose; fever (103F); headache; Cold like symptoms; This is a spontaneous repo...
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stuffed nose/stuffed up nose; fever (103F); headache; Cold like symptoms; This is a spontaneous report from a contactable consumer (consumer's daughter) via Medical information team. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 15:00 in arm, (want to say left arm but not sure) at single dose for COVID-19 immunization. Medical history included overweight 200 lbs upwards from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had fever (103F), stuffed nose and a headache on 05Jan2021. The fever went down in the afternoon. The patient asked if it be caused by the vaccine, 1 week later? The patient works in the dietary department of a senior residency facility. The patient received her first dose of Pfizer COVID-19 Vaccine on 28Dec2020. In the morning of 05Jan2021, she woke up with a fever of 100.3 degrees fahrenheit and cold like symptoms. She knows that those symptoms are associated with the Pfizer COVID-19 vaccine from the product paperwork she has; but her question is is it could the symptoms still be from the vaccine when the symptoms did not start until 05Jan2021. The patient was supposed to receive second dose of vaccine around 18Jan2020. She was tested for COVID-19 05Jan2021 with unknown result as of this time. She was tested for COVID-19 31Dec2020 which was negative as far as caller knows. Patient has been tested for COVID-19 for weeks and so far as far as she knows the results have been negative. The results are supposed to be a 24 hour turn around to get results; and the patient explained to caller that if she does not hear anything back about the tests then she assumes they are negative. The patient underwent lab tests and procedures which included body temperature: 103 fahrenheit and 100.3 fahrenheit on 05Jan2021, COVID test: negative on 31Dec2020 , and unknown result on 05Jan2021. The outcome of the event cold like symptoms was recovering while unknown outcome for the remaining events. Information about Lot/Batch number has been requested.
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| 30 | 2021-01-13 | chills, headache, weakness, fatigue |
Adverse event contacted by V-safe was that I was unable to perform my job duties the day after the v...
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Adverse event contacted by V-safe was that I was unable to perform my job duties the day after the vaccine. Symptoms included left arm pain, back pain, aches/chills starting at midnight on 1/6/21 into 1/7/21. Headache lasted all day, slept intermittently all day, low energy and extreme fatigue. Was 13 weeks pregnant at the time of the vaccine.
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| 30 | 2021-01-13 | shortness of breath, dizziness |
At 4:10 I awoke with pruritus and when i looked at my arms and I developed hives on my bilateral fo...
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At 4:10 I awoke with pruritus and when i looked at my arms and I developed hives on my bilateral forearms and bilateral hip area. I felt itchy all over. When I stood up, I felt palpitations and started to feel as if I was going to pass out. I sat down and I started to tremor and felt like it was hard to catch my breath. I took an antihistamine and took a puff of albuterol. I felt a lot better. At 10 AM in the morning, the hives have improved but i still feel some pruritus.
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| 30 | 2021-01-13 | headache, fatigue |
Day of vaccination no symptoms. Day after about 0730 had slight headache, sore arm, fatigue and loss...
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Day of vaccination no symptoms. Day after about 0730 had slight headache, sore arm, fatigue and loss of taste. Day 2 post vaccination only loss of taste, slightly improved.
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| 30 | 2021-01-13 | dizziness | Dizzy, tingling in left arm, chest tightness and heaviness, tongue feels weird |
| 30 | 2021-01-13 | fatigue | Fatigue, Nausea, Arm soreness Currently pregnant: EDD 08/20/2021 |
| 30 | 2021-01-13 | fever, fatigue | Fever 100.8, right arm soreness and fatigue. Treatment: Tylenol. Outcome: mild improvement |
| 30 | 2021-01-13 | chills, fever | Fever, chills, muscle aches, joint pain, back pain, vomitting, nausea |
| 30 | 2021-01-13 | headache |
Headache; pain/warmth at injection site; pain/warmth at injection site; nightmares; This is a sponta...
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Headache; pain/warmth at injection site; pain/warmth at injection site; nightmares; This is a spontaneous report from a non-contactable other health care professional. A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: lot number: EL0142), via an unspecified route of administration on 07Jan2021 at SINGLE DOSE at right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and Aspirin; and experienced allergies. On 07Jan2021, the patient experienced headache, pain/warmth at injection site, and nightmares. The outcome of the events was recovered. The patient took some ibuprofen as treatment. No follow up attempts are possible. No further information is expected.
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| 30 | 2021-01-13 | headache |
Joint pain and headaches. Also full body raised bumps (non pruritic, non pustular). Headaches resol...
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Joint pain and headaches. Also full body raised bumps (non pruritic, non pustular). Headaches resolved in about 1 week, joint pain and bumps have lasted a couple weeks now.
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| 30 | 2021-01-13 | headache, fever, chills |
Less than an hour after the shot, i had a sore arm, headache and slight sensitivity to light. I took...
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Less than an hour after the shot, i had a sore arm, headache and slight sensitivity to light. I took 975mg of Tylenol when I got home in the evening. But 12 hrs later after the vaccine shot, i woke up with severe body aches, chills, headache. Then i took another 975mg Tylenol but 3 hours later I started having fever that?s on and off. My fever even went up to 102.5F and the headache is very bad that is not relieved by Tylenol.
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| 30 | 2021-01-13 | migraine | Migraine, stiff neck, and body aches |
| 30 | 2021-01-13 | dizziness |
Patient began feeling dizzy and nauseous about 2 minutes after vaccine administration. She couldn?t ...
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Patient began feeling dizzy and nauseous about 2 minutes after vaccine administration. She couldn?t stand without falling. 911 was called and she was taken to the nearest hospital
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| 30 | 2021-01-13 | body temperature increased, dizziness |
Quickly after receiving vaccine patient began feeling lightheaded/dizzy then progressed to nauseated...
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Quickly after receiving vaccine patient began feeling lightheaded/dizzy then progressed to nauseated and feeling the need to vomit. Patients temperature increased slightly to 99.4. Placed a cool washrag on neck and gave Diphenhydramine 25mg at 12:15pm (patient stated had Benadryl at 6am at home before coming to work). Patients blood pressure was taken by parent who is a nurse at Woodridge 122/86. At 12:57pm patients temperature returned to 97.4 and patient was improving. Patients parent gave Zofran for the nausea/vomiting feeling at 1pm. Patient was feeling better but still dizzy and patients parent took the patient home at 1:18pm.
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| 30 | 2021-01-13 | fatigue, fever | Temp of 101.5, nauseous, fatigue, body aches, dry heaving |
| 30 | 2021-01-13 | dizziness | Upper arm soreness and dizziness both started 5.5 hours after receiving vaccine. |
| 30 | 2021-01-13 | throat swelling |
throat began swelling up; hives; This is a spontaneous report from a contactable other HCP. A 30-yea...
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throat began swelling up; hives; This is a spontaneous report from a contactable other HCP. A 30-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration from 06Jan2021 to 06Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: PCN. The patient's concomitant medications were not reported. On 06Jan2021, the patient stated that his throat began swelling up and also had breaking out into hives. The patient underwent lab tests and procedures which included nasal swab (COVID test): negative on 19Dec2020. Therapeutic measures were taken as a result of pharyngeal swelling and hives included Benadryl. Outcome of the events was not recovered. Information on the Lot/batch number has been requested.
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| 30 | 2021-01-13 | throat swelling, dizziness |
within 15': flushed, nauseated, throat swelling. dizzy., tachycardia Transferred to ED: treated wi...
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within 15': flushed, nauseated, throat swelling. dizzy., tachycardia Transferred to ED: treated with Benadryl. solumedrol. sx resolved. Observed for 4 hrs. d/cd to home
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| 30 | 2021-01-14 | shortness of breath |
20 hours after first dose of COVID19 vaccine arm was very sore (normal). Around 2:30am felt pressure...
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20 hours after first dose of COVID19 vaccine arm was very sore (normal). Around 2:30am felt pressure and warmth (coming in waves) up towards my chest, lasting 1-2 seconds and occurring about every 5 minutes . Was able to withstand feeling until it became difficult to breath. Lips and face turned white and blue, fainted. Felt extremely nausea when awake. Called 911. Vitals were normal apart from BP was very high 130/100's. EKG was NSR. Blood sugar taken was normal around 113. After 1 hour of event, I took a shower and drank water. I felt the wave one more time before trying to fall asleep. Then stopped. Woke up fine.
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| 30 | 2021-01-14 | chills | Chills, body aches, neck stiffness |
| 30 | 2021-01-14 | headache, nasopharyngitis, fever | Cold Symptoms , headaches , fever, chills |
| 30 | 2021-01-14 | headache |
Continuing headache and nausea for almost a week after second dose of vaccine. Lasting much longer t...
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Continuing headache and nausea for almost a week after second dose of vaccine. Lasting much longer than other reactions.
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| 30 | 2021-01-14 | headache, fever | FEVER, HEADACHE |
| 30 | 2021-01-14 | body temperature increased, chills, malaise, sweating, headache |
Got 2nd dose vaccine at 7:20 am at 5:30 pm I developed chills, went to bed around 8:30 due to not fe...
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Got 2nd dose vaccine at 7:20 am at 5:30 pm I developed chills, went to bed around 8:30 due to not feeling well. I woke up at 10 pm sweeting and body aches. All through the night I was hot then cold. I developed a temperature of 100.8. Had no appetite in the morning. At 7:30 am I started to feel better. Had head ache through out the day Thursday.
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| 30 | 2021-01-14 | headache | Headache, nausea and vomiting. Sleep and Ibupofen |
| 30 | 2021-01-14 | weakness |
Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; Itchiness, hives, ...
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Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; This is a spontaneous report from a contactable nurse (patient). A 30-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown unable to locate or read the details) via an unspecified route of administration at Left arm on 23Dec2020 14:15 at single dose covid-19 immunization. Facility type vaccine was Hospital. No known allergies and no other medical history. Concomitant medication included ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS), colecalciferol (VITAMIN D). No other vaccine in four weeks. The patient experienced itchiness, hives, wilts, abdominal pain on 01Jan2021 23:45. The events resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination and covid was not tested post vaccination. Treatment Benadryl was received for the events. The outcome of the events was recovered in Jan2021. Information about lot/batch number request.
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| 30 | 2021-01-14 | runny nose |
Mild pain at injection site and runny nose/sneezing day after vaccine; Mild pain at injection site a...
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Mild pain at injection site and runny nose/sneezing day after vaccine; Mild pain at injection site and runny nose/sneezing day after vaccine; Mild pain at injection site and runny nose/sneezing day after vaccine; This is a spontaneous report from a contactable pharmacist (patient herself). A 30-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot Ej1685), via an unspecified route of administration in the left arm on 21Dec2020 12:00 at single dose for Covid-19 immunisation. Medical history included allergy to PCN (rash to PCN as a child). No other vaccine in four weeks prior to Covid-19 vaccine. No Covid-19 prior to vaccination. The patient's concomitant medications were not reported. The patient experienced mild pain at injection site and runny nose/sneezing day after vaccine (22Dec2020). No treatment was given to the patient. The outcome of events was recovered.
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| 30 | 2021-01-14 | fatigue |
Myalgia; overwhelming fatigue; injection site pain and swelling; injection site pain and swelling; T...
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Myalgia; overwhelming fatigue; injection site pain and swelling; injection site pain and swelling; This is a spontaneous report from a contactable physician, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: Ek4176, via an unspecified route of administration on 08Jan2021 at 08:30 (at the age of 30 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included attention deficit hyperactivity disorder, gastritis, and hiatal hernia all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included spironolactone, ethinylestradiol, norgestimate (SPRINTEC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), and 'dexylan', all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of BNT162B2, lot number: Eh9899 on 18Dec2020 at 10:00 AM in the right arm. The vaccine was given at a Public Health Clinic. On 09Jan2021 at 12:00AM, the patient experienced myalgia, overwhelming fatigue, injection site pain and swelling. The patient did not receive treatment for the events. The clinical outcome of myalgia, overwhelming fatigue, injection site pain and swelling was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 30 | 2021-01-14 | throat pain, chills, sweating |
No reaction noted after first dose. Pt sts woke up on morning after first dose sweating, similarly ...
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No reaction noted after first dose. Pt sts woke up on morning after first dose sweating, similarly profuse from past experiences as if he was sick and feverish. Also had "pain" in his throat, a tightness in his chest, and intermittent chills. 14JAN21, condition the same, with worsening in tightness in chest and throat pain. 15JAN21 chest tightness has subsided but throat pain worse, no trouble swallowing. PT sounds congested when speaking. DNS SOB.
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| 30 | 2021-01-14 | chills, fever |
No symptoms following vaccination #1. Vaccination #2 received 1/13/21-no symptoms on 1/13/21. On 1/...
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No symptoms following vaccination #1. Vaccination #2 received 1/13/21-no symptoms on 1/13/21. On 1/14/20 pt reports fever 101.6, chills, body/muscle aches. These symptoms improved during day on 1/14/21. Pt reports evening of 1/14/2021 she began feeling like her skin hurt, burning feeling. On 1/15/2021, pt woke to hives across chest, abdomen, axillas, underside of arms and lateral torsos, scalp and posterior neck. Pt reports hives are present in area of painful skin the day prior. Pt reports hive were not initially itchy, but are at time of evaluation. Pt provided with care instructions for urticaria/hives, benadryl & OTC Allergy tablet instructions. She was also provided for s/s to watch-worsening hives, swelling,
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| 30 | 2021-01-14 | headache, fever | Reported headache,light sensativity,pain, heart palpitations and fever 103F |
| 30 | 2021-01-14 | dizziness |
Severe dizziness; almost blacked out; Nausea; Elevated heart rate.; This is a spontaneous report fro...
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Severe dizziness; almost blacked out; Nausea; Elevated heart rate.; This is a spontaneous report from a non-contactable health care professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (also reported as Pfizer-BioNTech COVID-19 mRNA vaccine, lot no: EK5730), via an unspecified route of administration on 08Jan2021 at 08:00 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took penicillin and experienced allergies. The patient was vaccinated in a hospital. The patient was not administered any other vaccine in four weeks and had no other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. It was reported that the patient experienced severe dizziness, almost blacked out, nausea and elevated heart rate on 08Jan2021 at 4:00 PM. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The events were reported to be non-serious.
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| 30 | 2021-01-14 | throat irritation |
Wednesday 1/13/2021 I woke up feeling like nauseous, then later in the day I started to get itchy in...
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Wednesday 1/13/2021 I woke up feeling like nauseous, then later in the day I started to get itchy in my lower body that was coming and going (I believe I still had some allegra d in my system). On Thursday 01/14/2021 by noon time the itching had become extreme and unbearable all over my body and felt like my skin was crawling/burning, my chest and parts of my arms were really red . I also developed a lump in my throat that kept getting bigger and felt itchy and couldn't stop clearing my throat. Around 3pm I took 10ml of Claritin. The Claritin had not really helped however the redness had gone down a lot and by 4:30 I was miserable. Informed by a provider I work with to go to urgent care. I arrived at urgent care at about 5:10 where I was treated for an allergy reaction. I was given 0.9% sodium chloride IV bolus 500mL, Methylprednisolone sod suc(PF) (SOLU-Medrol) 125mg Intravenous, Famotidine (Pepcid) 20mg/2ml injection 20mg intravenous, diphenhydramine (Benadryl) 50mg/ml injection 25mg intravenous. The itching subsided within 30 minutes, the itchy throat/ lump was still present but was not getting worse and slowly improving. I was discharged home and was told to pick up famotidine 20mg, otc benadryl and prednisone 50mg to take for 5 days. got home a little after 7 and was able to eat dinner, let dog out, shower, rest before going to bed. I did take another 10 ml of Benadryl at 10:30. Woke up without any itchy skin at 5:45 and was able to return to work this morning. I still have a slight itchy throat but it is tolerable. I took allegra d and famotidine this morning. I am holding off on the prednisone because of the immune response to vaccines from steroids. I don't want to lessen the effectiveness of the vaccine.
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| 30 | 2021-01-14 | fever, chills |
When the patient got sick she got a rash that didn't itch all over her body; Chills; aching; fever; ...
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When the patient got sick she got a rash that didn't itch all over her body; Chills; aching; fever; This is a spontaneous report from a contactable other health professional (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 06:45 AM at left arm, at single dose for covid-19 immunization. Medical history was none. Known allergies was no. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, unknown lot number and expiration date), via an unspecified route of administration on 18Dec2020 06:30 AM at left arm, at single dose for covid-19 immunization. The patient experienced chills, aching and fever 10 hours later at 08Jan2021 18:30. When the patient got sick she got a rash that didn't itch all over her body and it happened 24 hours after the vaccine, on 09Jan2021. No treatment was received for all events. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information on lot number/batch number was requested.
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| 30 | 2021-01-14 | shortness of breath, dizziness, throat irritation |
chest pressure, SOB, scratchy throat, light headedness, hoarse voice 12/29 - about 15 min after rece...
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chest pressure, SOB, scratchy throat, light headedness, hoarse voice 12/29 - about 15 min after receiving the vaccine employee reported mild chest pressure/pain, hoarse voice, SOB, light-headedness, and scratchy throat. (She was given the vaccine in the ED because of a history of anaphylaxis with taking antibiotics). Her physical examination and vital signs were normal. No evidence of swelling to lips, tongue or throat. No treatment was required. Employee was observed for 4 hours and discharged to home. She was diagnosed with a minor allergic reaction.
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| 30 | 2021-01-15 | sweating, chills |
Chills, body aches, sweats and nausea began about 8 hours after vaccination. Was received. Symptoms...
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Chills, body aches, sweats and nausea began about 8 hours after vaccination. Was received. Symptoms gradually got worse as the day went on. The symptoms we the worst at around the 24hr post vaccine mark. It is now almost 40 hours post vaccine and symptoms have improved but still remain. Symptoms improved with ibuprofen and Tylenol and rest.
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| 30 | 2021-01-15 | headache, dizziness | Dizziness, nausea, headache around 38hr s/p vaccine |
| 30 | 2021-01-15 | fever, chills |
Extreme chills, fever, body aches and swollen lymph node by neck on same side of injection. Lymph no...
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Extreme chills, fever, body aches and swollen lymph node by neck on same side of injection. Lymph node is painful at touch.
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| 30 | 2021-01-15 | headache, fever, chills, fatigue, shortness of breath |
Severe headache, fever of 103.9, tachycardia, lymphadenopathy, body aches, chills, fatigue, and shor...
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Severe headache, fever of 103.9, tachycardia, lymphadenopathy, body aches, chills, fatigue, and shortness of breath. Advised to go to Urgent Care on 1/14/2021. Was given fluids and toradol and told to continue to monitor and treat symptoms at home.
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| 30 | 2021-01-15 | fever, headache | swollen lymph nodes in left axilla, body aches, headache, low grade fever |
| 30 | 2021-01-16 | weakness, fever, dizziness |
2:30PM Chest pains, weakness, dizziness, feeling shaky. 6:20pm Tachycardia, hypertension, fever, fa...
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2:30PM Chest pains, weakness, dizziness, feeling shaky. 6:20pm Tachycardia, hypertension, fever, fainted, whole body went limp and unable to keep head up. 8:30 able to use arms again and feel them 10:30pm able to use legs and walk again
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| 30 | 2021-01-16 | skin warm |
3pm 1/13: sore left arm at injection site 9am 1/15: swollen lymph nodes in left armpit and a raised,...
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3pm 1/13: sore left arm at injection site 9am 1/15: swollen lymph nodes in left armpit and a raised, red, hot, painful patch of skin on left arm about 2 inches below injection site
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| 30 | 2021-01-16 | fatigue, headache |
Immediately after the vaccine, my arm started burning in my neck and opposite arm joints became very...
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Immediately after the vaccine, my arm started burning in my neck and opposite arm joints became very sore throughout the day my entire body became extremely sore and I developed an ear ache and a headache and I am very fatigued. Today is the 17th of the month and that your aching headache still has not always go away. I?m not sure if this is a normal reaction or not.
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| 30 | 2021-01-16 | fatigue, migraine | Migraine Body aches Large red painful lump at injection site Exhaustion |
| 30 | 2021-01-16 | dizziness, chills |
Woke up at 3 am with severe chills, went to the bathroom to check temperature. Got incredibly nauseo...
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Woke up at 3 am with severe chills, went to the bathroom to check temperature. Got incredibly nauseous and light headed. Passed out on the bathroom floor and hit my chin. Had to get stitches, fluid, and CT.
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| 30 | 2021-01-17 | malaise, chills |
Blacked out; Fainted; Felt very unwell; Nauseous; Chills; Fell; Knocked out, hit her nose, started t...
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Blacked out; Fainted; Felt very unwell; Nauseous; Chills; Fell; Knocked out, hit her nose, started to bleed; Humongous scar on her nose; In her hand there's a rash with different dots/red; She has petechiae/rash on the forearm; hit her face; knocked out, hit her nose; This is a spontaneous report from a contactable physician. This physician reported that a 30-year-old female patient (daughter) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced blacked out, fainted, felt very unwell, nauseous, chills, fell, knocked out, hit her nose, started to bleed, humongous scar on her nose, in her hand there's a rash with different dots/red, she has petechiae/rash on the forearm, all on an unspecified date in Jan2021. The Caller wanted information on side effects specifically looking at platelet or clotting or bleeding issues. Her daughter, (female, age 29 date of birth) received the 2nd dose of Pfizer vaccine, received it at the (State name), last night. She felt very unwell, nauseous, chills, and then blacked out, fell, knocked out, hit her nose, started to bleed; fainted and hit her face, didn't stop bleeding for 2 hours. There's a humongous scar on her nose. It took 2 hours to stop bleeding. She's going to urgent care today. Her daughter was healthy, yesterday was 2nd dose. In her hand, there's a rash with different dots/red. She has petechiae/rash on the forearm. Thankfully it (bleeding) did stop. The outcome of events for 'knocked out, hit her nose, started to bleed' was resolved on an unspecified date, for other events was unknown. The case was reported as non-serious. Information on the Batch/Lot number has been requested.; Sender's Comments: Based solely on a chronological association a causal relationship between events blacked out and fainted and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 30 | 2021-01-17 | headache, fatigue |
Fatigued for the rest of the day and following day, causing me to take multiple naps and was not abl...
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Fatigued for the rest of the day and following day, causing me to take multiple naps and was not able to complete some normal daily activities. Mild headache in the afternoon/evening on day of vaccine. Approximately 10 weeks pregnant at time of vaccine.
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| 30 | 2021-01-17 | throat pain, migraine | Migraine, Sore Throat |
| 30 | 2021-01-17 | fatigue, chills, headache, runny nose |
fist dose on 21Dec2020, second dose on 07Jan2021; pain and stiffness radiating from injection site a...
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fist dose on 21Dec2020, second dose on 07Jan2021; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; Started having chills; Severe headache; collapsed on the way back to bathroom and was unable to get up for about 20 minutes; tachycardia; extremely fatigued entire day; This is a spontaneous report from a contactable Pharmacist who reported for herself. A 30-year-old female patient received her second dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number Ej1685) at a single dose at 09:45 AM 07Jan2021 at left arm for Covid-19 immunization in a hospital. The patient had her first dose of Pifzer Covid-19 vaccine on 21Dec2020 at 12:00 PM at left arm, and experienced very mild reactions which included mild pain at injection site and runny nose/sneezing day after vaccine. The paitent had a medical hisotry of rash to penicillin as a child. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to her first dose of Pfizer COVID vaccine. In the evening of second vaccine (around 17:00), pain and stiffness radiated from injection site all the way down arm, into breast, and middle of back. She started having chills. Around 10 hours after dose chills became somewhat violent despite being under 4 blankets. Severe headache also started. In the middle of the night to go to bathroom, she collapsed on the way back and was unable to get up for about 20 minutes. She also suffered from tachycardia overnight. her baseline heart rate runs in 60s- 70s, but was in 110s-120s (based on Apple Watch monitoring). Day after vaccine, she was extremely fatigue entire day and spent all but a few hours in bed. Arm pain mostly gone. Headache was very strong and persistent through the day. On second night chills not as bad but still occurred overnight. HR still elevated in 80s overnight. Morning of day 2 still had headache and fatigue. The patient did not receive any treatment for the events. The outcome of collapse and unable to get up for 20minutes, pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back was resolved, chills and tachycardia was resolving, headache, fatigue was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The reporter considered that the events was non-serious.; Sender's Comments: Based on a chronological temporal association and known BNT162B2 vaccine safety profile, causality between events fainting, violent chills and severe headache and BNT162B2 ((Pfizer/ BioNTech Covid-19 vaccine) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 30 | 2021-01-17 | fever, headache, chills |
injection site soreness, Headache, Fever, nausea, muscle soreness, joint pain, shaking/ shivering to...
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injection site soreness, Headache, Fever, nausea, muscle soreness, joint pain, shaking/ shivering took 1 Tylenol at 2:15 am. woke up at 3:23 am to bout of SVT 154 and tachycardia for a few hours after.
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| 30 | 2021-01-19 | headache, chills, fatigue, fever |
12 hours later - chills, fever, body aches; headache; joint aches; fatigue. Called Urgent Care and t...
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12 hours later - chills, fever, body aches; headache; joint aches; fatigue. Called Urgent Care and they had me take- Imotrix that I already had and tylenol and hydrated - lasted 36 hours. Symptoms resolved.
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| 30 | 2021-01-19 | fever, chills, headache |
About 12 hours after - chills, fever , headache, body aches, joint ache (like flu) - lasted 36 hours...
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About 12 hours after - chills, fever , headache, body aches, joint ache (like flu) - lasted 36 hours. I hydrated - Took Imitrex that I still had; Tylenol and was back to normal after 36 hours. Called Urgent Care
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| 30 | 2021-01-19 | dizziness, fatigue |
Body aches - particularly elbow, knees, and hands. Fatigue. Occasional light headedness. All sympt...
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Body aches - particularly elbow, knees, and hands. Fatigue. Occasional light headedness. All symptoms were gone by following morning!
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| 30 | 2021-01-19 | fatigue, headache, chills |
DAY OF VACCINE: SORENESS AT INJECTION SITE MORNING AFTER VACCINE (1/12): BODY ACHES, CHILLS, MILD HE...
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DAY OF VACCINE: SORENESS AT INJECTION SITE MORNING AFTER VACCINE (1/12): BODY ACHES, CHILLS, MILD HEADACHE, FATIGUE, INTENSE SORENESS AT INJECTION SITE/ AFTERNOON & NIGHT (1/12): MORE FATIGUE AND SOME NAUSEA. 2ND MORNING AFTER VACCINE (1/13): SOME FATIGUE AND LIGHT NAUSEA. 2ND AFTERNOON AFTER VACCINE (1/13): NO SYMPTOMS. TOOK TYLENOL (EXTRA STRENGTH) & ADVIL.
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| 30 | 2021-01-19 | fever, headache | Fever, Nausea, headache, muscle aches |
| 30 | 2021-01-19 | fatigue, fever, headache, chills | Fever, chills, body aches, headache, fatigue. Improving. |
| 30 | 2021-01-19 | dizziness |
Patient with h/o hives from first dose (12/26/20) became lightheaded and dizzy 20-30 minutes after s...
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Patient with h/o hives from first dose (12/26/20) became lightheaded and dizzy 20-30 minutes after second dose. Received 25 mg Benadryl and Epi-Pen before being sent to the ED.
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| 30 | 2021-01-19 | shortness of breath, throat irritation |
Started with itchy mouth and itchy soft palate. Progressed to itchy throat. Gave 50mg of Benedryl wi...
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Started with itchy mouth and itchy soft palate. Progressed to itchy throat. Gave 50mg of Benedryl with no relief, progressed to difficulty breathing, and increased throat itching. Gave EPI pen and sent to ER
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| 30 | 2021-01-19 | dizziness, fatigue |
Systemic: Exhaustion-Mild, Systemic: Nausea-Severe, Systemic: Rise in BP, Dizziness, Kidney Pain-Med...
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Systemic: Exhaustion-Mild, Systemic: Nausea-Severe, Systemic: Rise in BP, Dizziness, Kidney Pain-Medium
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| 30 | 2021-01-19 | dizziness |
The patient received her first dose of the Pfizer vaccine on 12/26/2020. Following the second dose o...
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The patient received her first dose of the Pfizer vaccine on 12/26/2020. Following the second dose of the Pfizer vaccine, the patient became lightheaded, dizzy, and wheezed 20-30 minutes after the injection. 25 mg Benadryl administered, along with Epi-Pen. The patient was transported to the ED.
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| 30 | 2021-01-19 | fever, malaise, fatigue |
~12h after vaccine administration, severe body aches, fever, fatigue, malaise, nausea and vomiting l...
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~12h after vaccine administration, severe body aches, fever, fatigue, malaise, nausea and vomiting lasting ~18h.
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| 30 | 2021-01-20 | fever, weakness, dizziness |
Cardiac event; Paralysis; Fever; Numbness; Chest Pains; Dizziness; Weakness; This is a spontaneous r...
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Cardiac event; Paralysis; Fever; Numbness; Chest Pains; Dizziness; Weakness; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient started to receive first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 15Jan2021 14:15 at SINGLE DOSE for covid-19 immunisation. The patient was not pregnant. Medical history included tachycardia, Pre-ventricular contractions, allergies to Latex, covid-19 (reported as covid prior vaccination: Yes). Concomitant medication included metoprolol and multivitamin. No other vaccine received in four weeks. On 15Jan2021 14:30, the patient experienced chest pains, dizziness, weakness. On 15Jan2021 18:20, the patient experienced cardiac event, paralysis, fever, numbness, chest pains. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event)]. Treatment received for the events. No covid tested post vaccination. The outcome of the events was recovering. Information on batch/lot number was requested.
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| 30 | 2021-01-20 | headache, fever, chills |
body aches; full body chills; temp of 100.1; moderate headache; This is a spontaneous report from a ...
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body aches; full body chills; temp of 100.1; moderate headache; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (lot number unknown), via an unspecified route of administration in right arm, on 09Jan2021 08:00 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient experienced body aches, full body chills, temp of 100.1 and moderate headache on 09Jan2021 10:00 PM. Treatment was received for the events included Tylenol, ibuprofen. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 30 | 2021-01-21 | shortness of breath |
1 hour after receipt of booster vaccine, developed pruritis and difficulty breathing, throat tightne...
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1 hour after receipt of booster vaccine, developed pruritis and difficulty breathing, throat tightness; Stridor evident in the ED, hypotension requiring epinephrine injections and eventual infusion.
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| 30 | 2021-01-21 | migraine, fever, chills, headache, fatigue |
1/13 at 3 am started experiencing severe nausea/vomiting, severe diarrhea, severe body chills and ac...
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1/13 at 3 am started experiencing severe nausea/vomiting, severe diarrhea, severe body chills and aches, severe migraine and fever of 101.2F. Continued through 1/14 and missed work. Returned to work on 1/15 still having fatigue, nausea and severe headache.
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| 30 | 2021-01-21 | fever |
Fever, intense seizure for 10 min causing blackout, lost feeling in face and three toes, still can't...
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Fever, intense seizure for 10 min causing blackout, lost feeling in face and three toes, still can't feel 3 toes, lost consciousness.
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| 30 | 2021-01-21 | malaise, chills, headache, fever |
Received shot at 0610. Started feeling cruddy around 1600 w/ severe headache, neck pain, and shoulde...
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Received shot at 0610. Started feeling cruddy around 1600 w/ severe headache, neck pain, and shoulder pain, with overall malaise. Symptoms intensified at 2000 with severe rigors until ~0400 accompanied by body aches. Intermittent fevers experienced during that time as well. Next day, general malaise and severe body aches until ~1500; then subsided to mild headache and mild malaise. Post vaccine day #2 left with mild malaise, all other symptoms subsided.
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| 30 | 2021-01-21 | dizziness, throat pain, headache, fatigue, body temperature increased, weakness | chest pain fever of 102.0, sore throat, headache, dizziness, weakness tiredness |
| 30 | 2021-01-21 | discomfort, sweating, migraine, fatigue, body temperature increased |
extremely decreased blood flow (temperature) in extremities. Core far above normal temperature ( nor...
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extremely decreased blood flow (temperature) in extremities. Core far above normal temperature ( normally 96.8, currently 100.8). Sweating. Shaking due to cold extremities. Migraine. Pain in lower back (kidney area), chronic and achey. Joint pain in legs/ hips. Nausea constantly. Feeling of overall pain and discomfort. exhaustion.
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| 30 | 2021-01-21 | headache, chills, fever | fever (101.0) chills body Aches and joint pain when walking. headache and loss of appetite |
| 30 | 2021-01-24 | fever, fatigue |
Fever; Myalgias; Arthralgias; Costovertebral angle tenderness; Fatigue; This is a spontaneous report...
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Fever; Myalgias; Arthralgias; Costovertebral angle tenderness; Fatigue; This is a spontaneous report received from a contactable physician. A 30-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, in left arm, on 11Jan2021 at 18:45, for COVID-19 immunization. The patient received the first vaccine dose on 21Dec2020 at 16:00, intramuscular, in right arm, for COVID-19 immunization. No other vaccine was given in 4 weeks. The patient's medical history was none. The patient had no COVID before vaccination. Concomitant medication included drospirenone, ethinylestradiol betadex clathrate (YAZ). On 12Jan2021 at 13:00 the patient experienced fever, myalgias, arthralgias, costovertebral angle tenderness and fatigue. COVID was not tested after vaccination. No treatment was given. The events were resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 30 | 2021-01-24 | dizziness, throat irritation, shortness of breath |
Passed out; Chest tightness; Dizziness; Trouble breathing; Itching throat; This is a spontaneous rep...
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Passed out; Chest tightness; Dizziness; Trouble breathing; Itching throat; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration at site of left arm at 17:15 on 11Jan2021 at single dose for COVID-19 immunization. Medical history included migraine and seizure. Concomitant medication included lamotrigine (LAMICTAL) and zonisamide (ZONEGRAN). Both received within two weeks of vaccination. The patient experienced passed out, chest tightness, dizziness, trouble breathing, and itching throat, all at 17:30 on 11Jan2021. No other vaccines received in four weeks. Facility type vaccine was in hospital. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received salbutamol (ALBUTEROL), steroids, diphenhydramine hydrochloride (BENADRYL), lansoprazole (PREVACID) and IV fluids for treatment. No covid prior vaccination. No covid tested post vaccination. No known allergies. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
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| 30 | 2021-01-24 | chills, fatigue, headache, night sweats | headache, chills, body aches, temperature, fatigue, night sweats, 3 days |
| 30 | 2021-01-24 | chills, headache, fatigue | pain at site, fatigue , chills and headache |
| 30 | 2021-01-25 | cold sweat, fever, nasopharyngitis |
ACHES AND TINGLES. @12:45AM WOKE UP FREEZING WITH A FEVER. WEDNESDAY MORNING WOKE UP WITH A COLD SWE...
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ACHES AND TINGLES. @12:45AM WOKE UP FREEZING WITH A FEVER. WEDNESDAY MORNING WOKE UP WITH A COLD SWEAT. WEDNESDAY NIGHT- SAME SYMPTOMS BUT 10X WORSE. UNCONTROLLABLE SHAKES, FEVER, FREEZING, ENTIRES BODY ACHES. TOOK TYLENOL, NYQUIL AND ADVIL.
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| 30 | 2021-01-25 | nerve pain |
Extreme muscle stiffness and skin tenderness, burning hot (nerve pain over entire body lasting 5 min...
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Extreme muscle stiffness and skin tenderness, burning hot (nerve pain over entire body lasting 5 minutes every 30 minute or so) Tingling in my hands and finger tips.
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| 30 | 2021-01-25 | fever |
Fever of 104, causing febrile seizure. Symptoms began approx. 12 hours after vaccination. Patient ...
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Fever of 104, causing febrile seizure. Symptoms began approx. 12 hours after vaccination. Patient was hospitalized for observation for 15 hours.
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| 30 | 2021-01-25 | shortness of breath |
Shortness of breath - began with exertion but continued at rest for the rest of the day and into the...
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Shortness of breath - began with exertion but continued at rest for the rest of the day and into the next.
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| 30 | 2021-01-25 | body temperature increased, headache | Temp 100.4 Ha Body Ache, nausea |
| 30 | 2021-01-26 | fever |
Chest pain since 12/25/2020 (no treatment, written off as anxiety), flare of bursitis since 12/25/20...
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Chest pain since 12/25/2020 (no treatment, written off as anxiety), flare of bursitis since 12/25/2020 (solumedrol injections from rheumatologist in right knee and both shoulders), tingling in fingers, toes, & lips since 12/25/2020 (no treatment), psoriasis flare of face since 12/25/2020 (never experienced before reaching out to dermatologist) Low grade fever off and on 12/31/2020 until 1/11/2021
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| 30 | 2021-01-26 | headache, chills, fever | Fever, chills, body aches, headache. |
| 30 | 2021-01-26 | fatigue, headache |
Lymph node in my right armpit was swollen; Diarrhea; Exhausted/Still tired; Headache/ My head and bo...
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Lymph node in my right armpit was swollen; Diarrhea; Exhausted/Still tired; Headache/ My head and body still hurt; Felt sick; Broke out in hives all over my body; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain under my right breast/body still hurt; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 12Jan2021 13:00 at single dose in right arm for COVID-19 immunization. Medical history included the patient had known allergies to Erythromycin and pineapple. The patient had Covid-19 prior vaccination on an unspecified date. The patient had other concomitant medications. On 12Jan2021 14:00, 1 hour after vaccine the patient broke out in hives all over her body. The patient went to the ER at around 2-3pm. Later that night the patient had extreme pain in her right arm, upper right side of her back and under her right breast. The patient called ER and they told the patient to monitor it. The next morning on 13Jan2021 the patient was exhausted, had a headache and felt sick. Her right arm was painful to touch or lay on. The hives went down some. On 14Jan2021 the patient woke at 7am and her lymph node in her right armpit was swollen. It's painful to lower her arm due to the swelling. The patient was still tired and now the patient had diarrhea (on 14Jan2021). The patient's hives were less noticeable today. Her head and body still hurt. The patient had been on bed rest. No treatment was received for the events. The outcome of the events was reported as recovered with lasting effects in Jan2021. Information on the lot/batch number has been requested.
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| 30 | 2021-01-26 | nasal congestion |
Nasal congestion, uvular edema/erythema, stridor. Received 2 doses of epi followed by oral benadryl ...
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Nasal congestion, uvular edema/erythema, stridor. Received 2 doses of epi followed by oral benadryl 50 mg and 32 mg methylprednisolone; albuterol. Needed an additional 2 doses of epinephrine. Monitored for 3 hours.
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| 30 | 2021-01-26 | discomfort, fatigue, headache |
Symptoms s/p 2nd dose of Pfizer vaccine. Moderate to severe headache, nausea, body/joint aches and p...
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Symptoms s/p 2nd dose of Pfizer vaccine. Moderate to severe headache, nausea, body/joint aches and pain, and generalized fatigue resulting in inability to work the day after dose given. Fatigue started around 20:00 on 1/5/2021 (same date as 2nd dose administration), with increasing discomfort throughout the night. Symptoms continued until about 1:00 on 1/7/2021. Peak symptoms 1:00am-12:00pm on 1/6/2021.
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| 30 | 2021-01-26 | chills, fever, headache |
Woke up with chills, fever of 100.8, moderate headache, and body aches. I took 1000 mg of Tylenol wh...
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Woke up with chills, fever of 100.8, moderate headache, and body aches. I took 1000 mg of Tylenol which brought the fever down to 98.2, however, headache and body ache remained. I took Tylenol in 1000 mg doses around the clock every six hours for 24 hours, and 24 hours later felt no more symptoms.
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| 30 | 2021-01-28 | dizziness, shortness of breath |
Shortness of breath Chest Heavy Lightheaded; Shortness of breath Chest Heavy Lightheaded; Shortness ...
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Shortness of breath Chest Heavy Lightheaded; Shortness of breath Chest Heavy Lightheaded; Shortness of breath Chest Heavy Lightheaded; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiration date not reported), intramuscular on 14Jan2021 10:15 at single dose on the right arm for COVID-19 immunization. Medical history included chronic pain and known allergies to sulfa. The patient's concomitant medications were not reported. The patient experienced shortness of breath, chest heavy, lightheaded on 15Jan2021 at 10:00. The patient has not recovered from the events at the time of the report. The patient was not pregnant, has no prior COVID vaccination and was not tested for COVID post vaccination.
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| 30 | 2021-01-28 | influenza like illness |
flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 30-year-old...
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flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in right arm on 28Dec2020 at single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. On the first round of the vaccine the patient experienced flu like symptoms on an unspecified date. The outcome of the event was unknown. The facility where the most recent COVID-19 vaccine was administered was in the hospital.
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| 30 | 2021-01-31 | chills, sweating |
My white blood count went really high; The first dose was on 28Dec2020 and the Lot: EH9899. The seco...
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My white blood count went really high; The first dose was on 28Dec2020 and the Lot: EH9899. The second dose 12Jan2021 at 7am, Lot: EL1284; Extremely achy/Body aches; Chills; Back hurts so bad that she can't lay down; Sweating; The first round of the vaccine she had flu like symptoms. This time, with the second dose, it is more severe; The first round of the vaccine she had flu like symptoms. This time, with the second dose, it is more severe; This is a spontaneous report received from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), via an unspecified route of administration in the right arm, on 12Jan2021 07:00, at single dose, for COVID-19 immunization, in the hospital. The patient medical history and concomitant medications were not reported. The patient had no allergies. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), via an unspecified route of administration, on 28Dec2020, for COVID-19 immunization and the patient had flu-like symptoms. The patient reported that with the first round of the vaccine, she had flu like symptoms. This time in Jan2021, with the second dose, it was more severe and if she didn't keep up with Tylenol, she was extremely achy, had chills, her back hurts so bad that she couldn't lay down, and sweating. The patient wanted to know if that was normal. The patient mentioned she called out of work for the rest of the week and left early on Tuesday. The patient stated that she had not been to the doctor at this point but when Tylenol wears off it was really ugly and would consider going. The patient stated that she was almost on septic. Her white blood count went really high on 12Jan2021 and was hospitalized from 16Jan2021. She was put on Cefepime, 2 gm per vial, gotten maybe 4 of them so far. Body aches was ongoing. Her blood work was getting better. The outcome of events white blood count went really high, extremely achy/body aches was not recovered.The outcome of other events was unknown. Follow-up (17Jan2021): New information from a contactable consumer (patient) includes: Reaction data (add event white blood count went really high, outcome of event extremely achy/body aches updated). This case has been upgraded to serious.
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| 30 | 2021-02-03 | weakness, fatigue, dizziness |
I was so faint/nearly passed out; so hot; very chilled for about 15 or 20 minutes; feeling sort "off...
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I was so faint/nearly passed out; so hot; very chilled for about 15 or 20 minutes; feeling sort "off"; weak; fatigued/very drained/exhausted; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176), via an unspecified route of administration on 19Jan2021 at 08:15 AM at single dose in right arm for COVID-19 immunisation. Patient age at time of vaccination was years 30 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no known allergies. The patient had no relevant medical history and received no concomitant medications. The patient reported the following: 'About 5 minutes after receiving the vaccine I was so faint I nearly passed out and was so hot I was given an ice pack to try and cool me down. It took about 45 minutes for me to be able walk across one room. I then was very chilled for about 15 or 20 minutes, and very drained. The rest of the day I was back and forth between feeling sort "off" and feeling like I was weak, exhausted, and fatigued'. Adverse events onset date was reported as 19Jan2021 at 08:15 AM. No treatment was received for the events other than ice pack for feeling hot. The patient was recovering from the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
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| 30 | 2021-02-03 | body temperature increased, fever |
anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a nurse reporting fo...
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anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a nurse reporting for herself. A 30-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 prophylaxis . Medical history included ongoing asthma Diagnosed when she was a child , seasonal allergy , food allergy , contrast media allergy (gadolinium). There were no concomitant medications. The patient experienced anaphylactic reaction on 13Jan2021 with outcome of recovered , had a fever of 100.8 on 13Jan2021 with outcome of recovered. The patient underwent lab tests and procedures which included allergy test: unknown results on Jan2021 , body temperature: 100.8 on 13Jan2021. The reaction began 28 minutes later. She says she started to get jumpy, her hands swelled and got itchy. She couldn't bend her hands, they were so swollen that she couldn't bend them. Her legs were shaking. Then saline and eventually her mouth started to get numb and they used an Epi pen twice. Her throat never closed, she thinks it did not close because the Epi pen was done twice, She had 2 masks on she cannot say for sure if she had trouble breathing but her mouth began to get dry and tingly and she started to no be able to feel her mouth. She says she would says it was resolved completely the next day. The patient also received Decadron and Benadryl. The reporter would say the event were life threatening because they treat it that way due to anaphylaxis precautions. Follow up information has been requested.
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| 30 | 2021-02-08 | fatigue, weakness |
Approximately 12 days after vaccination co began to have fatigue, weakness, Pancytopenia Recent...
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Approximately 12 days after vaccination co began to have fatigue, weakness, Pancytopenia Recent hospitalization which involved initial presentation at hospital on AK 12/29, and then again on 12/30, after eval on 12/30 was then transferred to another hospital, and later transferred where she later recovered and was discharged. She was initially very ill and was thought to have sepsis due to fever/initial presentation/clinical picture, also had lab abnormalities including thrombocytopenia. These things necessitated transfer. While at hospital, hematology was consulted. Decision was made to transfer due to concern for DIC/possibility of leukemia. Also there was concern for C Diff, treatment was given for this. While in hospital, she underwent further testing on blood samples which revealed no evidence for malignancy, also bone marrow biopsy was performed. While there, DIC labs were trended/began to improve. Discharged on 1/5/21. Had f/u with hematology @ hospital on 1/12/21. No reason has been found as of yet as to why she became ill. Per discharge note it's thought it could have been viral in nature, or possibly related to supplement use. Will f/u with heme in early Feb. Of note, she does report getting her first dose of pfizer covid vaccine on 12/17/20, she reports concern that this could have played a part in her illness. She states this was the only new/out of the ordinary thing that she can remember recently, regarding her medical hx, prior to recent acute illness/hospitalization. Requests I reach out to inquire how she can file a report with Pfizer or CDC
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| 30 | 2021-02-08 | malaise, headache, fatigue |
diarrhea (7+ loose stools each day starting on this day); headache; severe nausea; worsened muscle p...
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diarrhea (7+ loose stools each day starting on this day); headache; severe nausea; worsened muscle pain; new joint pain morning after (Included in aforementioned, but significant stiff neck.); new joint pain morning after (Included in aforementioned, but significant stiff neck.); fatigue/malaise; fatigue/malaise; This is a spontaneous report from a contactable other HCP report for self. This 30-year-old not pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) Intramuscular at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Asthma, anxiety, allergies to Acetaminophen (seizure like activity and fainting). No COVID prior vaccination. No other vaccine in four weeks. Other medications in two weeks includes fluoxetine, lorazepam, and Ibuprofen. Patient received first dose of bnt162b2 (lot number: EL0140) on 30Dec2020 and experienced injection sight tenderness, severe headache and fatigue. On 20Jan2021 5:00 PM after the second dose, patient experience headache, severe nausea, diarrhea (7+ loose stools each day starting on this day), worsened muscle pain several hours later, new joint pain morning after (Included in aforementioned, but significant stiff neck), fatigue/malaise. Patient received Ibuprofen and rest, supportive care due to events. The outcome of event was not recovered. Rapid Nasal Swab tested Negative on 21Jan2021.; Sender's Comments: The reported event diarrhea was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship, and considering no alternative cause reported currently. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 30 | 2021-02-08 | sweating |
sudden onset lower lip angioedema- only on the right side of my lip; This is a spontaneous report fr...
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sudden onset lower lip angioedema- only on the right side of my lip; This is a spontaneous report from a contactable Other HCP. This other HCP reported different events for the same patient during diffferient vaccination dose. This case is referred to the second vaccine dose A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL3247 intramuscular on 13Jan2021 12:30 second dose at SINGLE DOSE for covid-19 immunisation. Facility type vaccine: Hospital . Vaccine location: right arm Medical history included asthma, eczema, hypersensitivity, anxiety and depression. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20), bupropion hydrochloride (WELLBUTRIN XL), fluoxetine hydrochloride (PROZAC), rizatriptan (RIZATRIPTAN), salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), levocetirizine dihydrochloride (XYZAL), betamethasone (BETAMETHASONE). The patient previously took aspirin and experienced rash. The patient experienced flushing, palpitations and hyperhidrosis after the first dose of bnt162b2 vaccine. The patient experienced sudden onset lower lip angioedema- only on the right side of my lip on 16Jan2021 20:30 with outcome of recovered. The action taken was not applicable. Therapeutic measures were taken: benadryl inhaler self treated, consultation w/allergist and allergy testing. The reporter stated "developed sudden onset lower lip angioedema only on the right side of my lip. I took 50mg benadryl and my inhaler and monitored- I never developed itching, additional swelling, difficulty breathing or other symptoms of anaphylaxis. Swelling had resolved by morning. I had no other new exposures that have yet been identified, although I am going through a work up with an allergist."; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021073355 Same patient/ drug, different dose/AE.
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| 30 | 2021-02-08 | chills, dizziness |
tingling with pins and needles feeling all through arms, legs, face; nausea; dizziness sight; chills...
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tingling with pins and needles feeling all through arms, legs, face; nausea; dizziness sight; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on the left arm on 21Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included "Celtics disease", allergies to gluten and negative COVID-19 test nasal swab on 10Oct2020. Concomitant medication included birth control and prenatal vitamin. Patient did not have COVID prior to vaccination and was not pregnant. Vaccination was received in the hospital and no other vaccine was received four weeks prior. On 21Jan2021 16:00, the patient reported nausea, dizziness sight and chills were normal then she had tingling with pins and needles feeling all through arms, legs, face. She still had prickling feeling in arms and her left foot was tingling and it had been four days later. The adverse events pins and needles reportedly resulted in disability or permanent damage. Patient has been tested for COVID post-vaccination on an unspecified date with unknown results. Treatment was received for the events. Outcome of the events was not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of prickling feeling in arms and her left foot tingling cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 30 | 2021-02-09 | shortness of breath, throat swelling |
Anaphylaxis; persistent throat swelling; nasopharynx/oropharynx edema; difficulty breathing; difficu...
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Anaphylaxis; persistent throat swelling; nasopharynx/oropharynx edema; difficulty breathing; difficulty swallowing; choking sensation; This is a spontaneous report from a contactable Physician. A 30-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The relevant medical history included known allergies: sulfa from an unspecified date. Concomitant medications were not reported. The patient experienced anaphylaxis: followed by persistent throat swelling, nasopharynx, oropharynx edema causing recurrent difficulty breathing, choking sensation and difficulty swallowing on 14Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient underwent lab test included Covid which showed negative on an unspecified date post vaccination. The outcome of the events was unknown.; Sender's Comments: Based on a close chronological association a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 30 | 2021-02-17 | respiratory tract congestion, chills, fever |
I basically had all of the symptoms of Covid. I exp nausea, diarrhea, 103. temp, chills(got fever un...
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I basically had all of the symptoms of Covid. I exp nausea, diarrhea, 103. temp, chills(got fever under control was gone in a day), body ache,congestion lasted 3 days. I went to the ER twice first time discharged to go home rest and second time told it might of been food poisoning,
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| 30 | 2021-02-21 | throat swelling, fatigue, shortness of breath, cough, malaise |
Fine for hour or so then began to lose voice slowly over the next few hours and cough. Shortness of ...
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Fine for hour or so then began to lose voice slowly over the next few hours and cough. Shortness of breath from simply walking around swelling of the glands and consul in the neck and throat
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| 30 | 2021-02-22 | dizziness, headache |
Intense dizziness and vertigo. First two days- nearly constant and accompanied by nausea and headach...
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Intense dizziness and vertigo. First two days- nearly constant and accompanied by nausea and headache. Dizziness lasting for more than 1 week. Vertigo still present after 7 days if laying in certain positions. Taking meclizine as needed for dizziness and motion sickness.
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| 30 | 2021-02-23 | fatigue, fever, headache |
Headache; Tiredness; Fever; This is a spontaneous report from a contactable consumer (patient). A 30...
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Headache; Tiredness; Fever; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 09Feb2021 at 17:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 09Feb2021 at 19:00, the patient experienced headache, tiredness and fever. Patient received Acetaminophen as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events were recovered on an unspecified date. The events were considered non-serious.
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| 30 | 2021-02-23 | throat irritation |
Noted difficulty swallowing 10 minutes post vaccination. Observed, given water, client notes previou...
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Noted difficulty swallowing 10 minutes post vaccination. Observed, given water, client notes previous rx to radio active iodine. Notes scratchy throat, tingling and puffy lips. Symptoms did not worsen over 60 minutes in observation. No difficulty breathing. Advised to take benedryl and seek medical attention if symptoms worsen. Patient left with her mother. RN called later in the evening, client confirmed sxs improved with Benedryl, feeling better.
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| 30 | 2021-02-23 | chills |
Patient was experiencing rash and chills after her second dose of COVID19 vaccine, treated herself w...
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Patient was experiencing rash and chills after her second dose of COVID19 vaccine, treated herself with benadryl to resolve. Rash re-appeared following day, presented to the ED received solumedrol, fluids and benadryl, and she was discharged with ranitidine and hydroxyzine (2/21). She returned on 2/23 to ED, presented with rash, tachycardia and c/o abdominal pain . She was treated with methylprednisolone 15mg, 1L of LR, 1L of NS, and 50 mg IV diphenhydramine, 0.3 mg IM Epinephrine, and 20 mg of famotidine IVx1. Patient was continued on prednisone 40 mg po bid and famotidine 20mg po bid.
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| 30 | 2021-02-25 | influenza like illness |
Painful left arm (where vaccinated); flu like aches; feeling cold; This is a spontaneous report from...
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Painful left arm (where vaccinated); flu like aches; feeling cold; This is a spontaneous report from a contactable consumer reporting for herself. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 10Feb2021 at single dose in Left arm for COVID-19 immunisation. Medical history included coeliac disease from an unknown date. There were no Allergies to medications, food, or other products. The patient was not Pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), on 20Jan2021 at the age of 30-year-old at single dose in Left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Painful left arm (where vaccinated). She experienced flu like aches the day after vaccination as well as feeling cold on 11Feb2021. Since the vaccination, the patient had not been tested for COVID-19There was no treatment received for the adverse event. The outcome of events was recovered. The events were reported as non-serious.
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| 30 | 2021-02-27 | nerve pain |
1/1/21- Severe right side eye pain 1/3/21 - Appearance of vesicular rash with sever pain above righ...
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1/1/21- Severe right side eye pain 1/3/21 - Appearance of vesicular rash with sever pain above right eyelid 1/3/21 - Diagnosed with Zoster Ophthalmicus of Right Eye at urgent care and initiated on Valacyclovir 1000 mg PO TID x 10 days 1/4/21 - Ganciclovir eye drops added to treatment course 1/10/21- Rash crusted and resolved but with severe neuropathic pain and itch 1/12/21 - Second dose of COVID vaccine received
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| 30 | 2021-02-28 | fatigue, nasopharyngitis, dizziness, somnolence, fever |
whole body felt sore and exhausted; whole body felt sore and exhausted; bad cold/flu; bad cold/flu; ...
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whole body felt sore and exhausted; whole body felt sore and exhausted; bad cold/flu; bad cold/flu; little chest pain; minor fever; blood pressure dropped; dizziness; backpain; left arm felt sore; sleepy/light drowsiness; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on the left arm on 11Feb2021 15:30 at a single dose (at the age of 30-years-old) for COVID-19 immunization. Medical history included >13 years ago: diagnosed TB with no symptom, completed TB treatment 1 year-plan and has issue no since then; >16 years ago: Hepatitis-b positive but received treatment and cleared out on diagnostics afterward. The patient was not pregnant. Concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient has no known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 21Jan2021 at 13:15 on the left arm at a single dose (at the age of 30-years-old) for COVID-19 immunization. After about 4.5h post-vaccination (20:00), her left arm felt sore and within the next 3h, she felt sleepy and experienced random light drowsiness. She woke up around 06:30 the next day (12Feb2021) only felt continued sore arm. However, at 08:30 to 09:30, her whole body felt sore and exhausted, especially back pain, as if she having a bad cold/flu. She also felt a little chest pain, had a minor fever and went sleeping from 12:00, woke up around 18:00-19:00. The whole body ache was almost gone but her back was still in pain and her blood pressure dropped with random dizziness when she was walking or standing up. The next morning (13Feb2021), the back pain was gone and she felt it back to normal except for a little random dizziness in movement. She did not take any medication to alleviate the adverse effects during the timeline. The patient was not COVID tested post vaccination. The patient recovered from back pain in 13Feb2021, the patient recovered from the remaining events in Feb2021.
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| 30 | 2021-03-02 | thirst |
Dry mouth; excessive thirst; This is a spontaneous report from a non-contactable healthcare professi...
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Dry mouth; excessive thirst; This is a spontaneous report from a non-contactable healthcare professional (patient). A 30-year-old non-pregnant female patient received first dose of BNT162B2, via an unspecified route of administration (Vaccine location: right arm) on 29Jan2021 20:00 at a single dose for COVID-19 immunization at a hospital. Medical history included insomnia, anxiety, sebbhoreic dermatitis, and Covid prior vaccination. Concomitant medications included retinol, dandelion, melatonin, and unspecified multivitamin. No other vaccine in four weeks. On 29Jan2021 11:00 PM, the patient experienced dry mouth/excessive thirst (this is a side effect she has not yet seen listed). Every other symptom was pretty par for the course. No treatment received for the events. No Covid test post vaccination. The patient recovered from both events on an unspecified date. No follow up attempts are possible. No further information is expected.
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| 30 | 2021-03-02 | chills, headache, dizziness |
extreme stomach cramps; vomiting; dizzy; headache; chills; This is a spontaneous report from a non-c...
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extreme stomach cramps; vomiting; dizzy; headache; chills; This is a spontaneous report from a non-contactable other health professional (patient). A 30-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 28Jan2021 14:30 at single dose for Covid-19 immunization in a workplace clinic. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior vaccination. Historical vaccine included first dose of BNT162B2 lot number EL1284 on 01Jan2021 for Covid-19 immunization. The patient received other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021, the patient experienced extreme stomach cramps, vomiting, dizzy, headache, chills. The patient did not received treatment for the adverse events. The patient has not been tested for COVID-19 since vaccination. The outcome of the events was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. No follow-up attempts are possible. No further information is expected.
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| 30 | 2021-03-03 | fatigue |
Arm soreness; Minor fatigue; This is a spontaneous report from a contactable consumer (reporting for...
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Arm soreness; Minor fatigue; This is a spontaneous report from a contactable consumer (reporting for herself). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3247), via an unspecified route of administration single dose arm left (at the age of 30) on 02Feb2021 for covid-19 immunisation. No other vaccine was received in four weeks. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm soreness on 02Feb2021, minor fatigue on 02Feb2021. No treatment received. The events outcome was recovered.
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| 30 | 2021-03-15 | throat irritation |
Pt had itchy throat, tight throat, sense of doom at 30 min obs mark. Was given EPI and transferred t...
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Pt had itchy throat, tight throat, sense of doom at 30 min obs mark. Was given EPI and transferred to local ED. Had rebound anaphylaxis days later (3 days after) resulting in 2nd ED trip.
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| 30 | 2021-03-17 | dizziness, dehydration, sweating |
Within 15-minutes of vaccination, the patient had a syncopal event preceded by nausea and lightheade...
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Within 15-minutes of vaccination, the patient had a syncopal event preceded by nausea and lightheadedness. EMS evaluated the patient on-site. The patient was pale, diaphoretic, and hypotensive (67/37). EKG (3/12): Sinus brady, rate 46 bpm, no ST elevation. FSBG (3/12): 89mg/dl. EMS administered 500mL IV saline. EMS transported the patient to Hospital Emergency Department. In the ED, the patient feels back at baseline and was normotensive (119/72). Patient stated they have a history of vasovagal response and vasovagal vomiting, but had never experienced a vasovagal syncope episode. Physician administered 0.5mg Lorazepam. The ED physician admitted the patient to the telemetry unit for vasovagal syncope due to patient's prodrome and prior history of similar near syncopal episodes. Inpatient attending agreed that the patient's vasovagal response may be secondary to poor PO intake with extreme stress. Patient's admission was less than 1-day and stated they were anxious to return home. Discharged with diagnoses of Mild leukocytosis, Vasovagal response, and Orthostatic hypotension secondary to dehydration.
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| 30 | 2021-03-18 | somnolence, dizziness, sweating |
1022 - Patient received her 1st Pfizer vaccine by RN. She noted a history of vasovagal syncope to n...
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1022 - Patient received her 1st Pfizer vaccine by RN. She noted a history of vasovagal syncope to needles in the past (did not seem like it was complete syncope to all needle sticks per RN). RN offered for her to lie down, but she said she felt ok sitting. She did not endorse any history of severe allergies or reactions to injectables in the past; she was asked the necessary questions prior to vaccination. We later learned she has Crohn?s and is on immunosuppressant Imuran for this disorder. 1023ish ? walked to checkout area 1025 - While sitting at the checkout registering for her second shot she started to feel faint and checkout staff called for help 1026 - RNs were getting the BP cuff on her. She appeared obtunded and slouching in her chair- eyes closed. Gentle sternal rub and she was able to open her eyes and tell us what her name was and ask to call her dad. BP 90/58. Cold cloths placed on her neck. Continuous pulse ox monitor placed, showing 99%. 1030 - Still drowsy and diaphoretic. Able to tell us that "she passes out when she gets shots" C/O nausea and vomited. Still in and out of awareness. NP is site coordinator is now present and suggests taking patient by wheelchair to safer and more private area for evaluation in SR Room. Patient able to stand and transfer to wheelchair, which we did slowly and carefully. 1034 ? Now in safer and more private area SR room with NP and RN and Dr. Firemen are here and assessing the scene with medic assessing patient. Ambulance in route, about 5 - 10 minutes out per radio communication. Checking BP every 2 minutes. Now is 68/44. C/O nausea and vomited. Pulse ox won?t pick up. Patient with decreasing LOC, eyes rolling back in head, unable to maintain posture seated, and not able to describe symptoms to us (unknown if she felt itchy but no obvious cutaneous manifestations). Unable to visualize oropharynx. 1037- BP 57/40. NP administered Epi pen 0.3 mg dose to L lateral thigh due to s/s of systemic allergic reaction/anaphylaxis including 3 known body systems: hypotension (cardiovascular), vomiting (GI), and decreased LOC (neuro). No IV fluids immediately available but were preparing to obtain. Staff getting cot for patient to lie down. Provider spoke with her mom on the phone and informed her of event. Mom confirmed that she has often before passed out with vaccines and blood draws. Dad was on his way to center and rerouted to ER. 1038 - BP 68/45 Talking to medics and able to tell them she ate breakfast and that she has a hx of Crohn's and takes a monthly injection. Informed provider that her dad was on his way. EMS team here to transport to ER. We were preparing to put her on a cot so help with her blood pressure/blood flow when she started to stabilize and EMS arrived with stretcher. 1040 - BP 97/53. Patient is now alert and talking to us. Says she has had syncope in the past ?but never anything like this.? 1041 - BP 115/53. Patient still alert and talking. Oriented x 3. 1042 - Transported to ER by EMS ambulance on stretcher. DEBRIEF: Somewhat atypical (no obvious cutaneous manifestations) and rapid, severe reaction. Ddx vasovagal vs anaphylaxis. Response to epi consistent with anaphylaxis reversal. Perhaps immunosuppressant medication contributed to severity and rapidity of reaction.
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| 31 | 2020-12-31 | headache |
Associate has history of asthma was planned to be observed for 30 minutes. at 12:30 patient complain...
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Associate has history of asthma was planned to be observed for 30 minutes. at 12:30 patient complained of light headache which fully resolved after 30 minutes. no further intervention.
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| 31 | 2021-01-01 | pneumonia | Left lower lobe Pneumonia with small pleural effusion |
| 31 | 2021-01-02 | headache, malaise |
Two days after receiving first dose of Pfizer COVID vaccine started feeling generally unwell. On the...
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Two days after receiving first dose of Pfizer COVID vaccine started feeling generally unwell. On the third day, started feeling progressively worse: dizziness upon standing and while standing (to the point I thought I would fall over) nausea, dry heaving, headache bordering on migraine, abdominal pain and a short period of appetite loss. Today (fourth day post shot) I called out of work and feel as if I?m on a tilt table while laying down, and will feel dizzy and nauseated immediately upon standing up. This is is spite of staying hydrated and eating a bland diet in order to not upset my stomach.
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| 31 | 2021-01-02 | headache | severe headache lasting 24 hours |
| 31 | 2021-01-03 | chills, dizziness |
15 minutes after vaccine patient had light headedness, body chills and patient said she had a "rush ...
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15 minutes after vaccine patient had light headedness, body chills and patient said she had a "rush of blood feeling in her body". Vital signs remained stable and patient observed x 90 mins.
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| 31 | 2021-01-03 | headache |
Immediately I got nauseas and headache. Next day my whole lower back was spasm and had horrible body...
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Immediately I got nauseas and headache. Next day my whole lower back was spasm and had horrible body pain/back pain. I almost passed out putting pants on. A friend took me to an Urgent care they gave me Shot of tramadol and given Tylenol 3. They also did a test on my kidney. About 50 hours after the shot I was feeling better.
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| 31 | 2021-01-03 | chills, malaise, fever |
PT REPORTED HYPOTENSION/BRADYCARDIC EPISODE, BODY ACHES, CHILLS, FEVER, MALAISE FOR 2.5 DAYS. PT WEN...
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PT REPORTED HYPOTENSION/BRADYCARDIC EPISODE, BODY ACHES, CHILLS, FEVER, MALAISE FOR 2.5 DAYS. PT WENT TO HOSPITAL FOLLOWING REACTION. SHE WAS NOT HOSPITALIZED, SEVERE SYMPTOMS RESOLVED WITH REST AND HYDRATION. CONSULTED WITH PCP AND MONITORED FREQUENTLY.
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| 31 | 2021-01-03 | chills |
Significant neck and upper back pain as soon as 1 hour post vaccine lasting until at least 24 hours ...
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Significant neck and upper back pain as soon as 1 hour post vaccine lasting until at least 24 hours - tylenol and heat/ice (no change) chills without fever overnight the night of - no treatment soreness in arm 1 hr post to up to its worst at 24 hours later when I could not abduct >90 degrees for 24 more hours
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| 31 | 2021-01-03 | dizziness |
Started with hot flashes , light headed, partial facial numbness on the ride side. Light heart pro...
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Started with hot flashes , light headed, partial facial numbness on the ride side. Light heart problems
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| 31 | 2021-01-03 | dizziness |
patient stated felt numbness in her left middle finger and thumb. Started feeling lightheaded and th...
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patient stated felt numbness in her left middle finger and thumb. Started feeling lightheaded and though she was going to pass out. Patient states she has needle phobia and has had this happen in the past.
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| 31 | 2021-01-04 | dizziness |
Intermittent dizziness and it doesn't last very long usually its usually couple of times a day; This...
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Intermittent dizziness and it doesn't last very long usually its usually couple of times a day; This is a spontaneous report from a contactable nurse, the patient. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot "EJ then it's either I or 1, I don't know then 685", Expiry Date: 31Mar2021) solution for injection intramuscular on 19Dec2020 (at the age of 31-years-old) as a single dose for COVID-19 vaccination. Pregnancy status was not reported. Medical history was unknown. Concomitant medication included multivitamins. The patient stated, "I just wanted to know if it's normal or not, I got this first half of the Covid Vaccine on the 19Dec2020 and ever since I have been having like intermittent dizziness (19Dec2020) and it doesn't last very long usually its usually couple of times a day but I just wanted to know if that's normal and if it is how long before it stops?" No treatment was provided for the event intermittent dizziness. The outcome of the event intermittent dizziness was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 31 | 2021-01-04 | fever |
Pfizer-BioNTech COVID-19 Vaccine EUA Fever up to 101.0 degrees Fahrenheit for several hours, which r...
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Pfizer-BioNTech COVID-19 Vaccine EUA Fever up to 101.0 degrees Fahrenheit for several hours, which reduced with Tylenol and ibuprofen.
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| 31 | 2021-01-04 | headache, fatigue |
The next day I was feeling fatigue. My arm was sore & I had headaches. I did talk to a clinic virtua...
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The next day I was feeling fatigue. My arm was sore & I had headaches. I did talk to a clinic virtually for my headaches.
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| 31 | 2021-01-04 | fever, headache, fatigue |
fever. Highest temperature was 101.1 F. I took tylenol which only brought it down to 100.6 F an hour...
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fever. Highest temperature was 101.1 F. I took tylenol which only brought it down to 100.6 F an hour later. Fever lasted for 5 hours total; back aches/achiness were better after sleeping for the night; headache; Fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at left arm on 24Dec2020 08:30 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included Baseline leukopenia. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 12 hours after the vaccine the patient developed back aches, headache, and a fever. Highest temperature was 101.1 F. The patient took Tylenol which only brought it down to 100.6 F an hour later. Fever lasted for 5 hours total. Fatigue and achiness were better after sleeping for the night. Events onset date was provided as 24Dec2020 11:30 PM. No treatment was received for the events of back aches, headache and fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event fever was recovered on 25Dec2020 04:30, the outcome of the other events back aches, headache and fatigue was recovered on an unknown date in Dec2020.
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| 31 | 2021-01-04 | fatigue, fever |
fever; myalgia; body ache; fatigue; This is a spontaneous report from a non-contactable other health...
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fever; myalgia; body ache; fatigue; This is a spontaneous report from a non-contactable other healthcare professional (HCP). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number ek5730) intramuscular in the left arm on 20Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 24Dec2020, the patient experienced fever, myalgia, body ache and fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19. After the vaccination, on 26Dec2020, the patient was tested for COVID-19 with a nasal swab which resulted negative. At the time of the report, the outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 31 | 2021-01-04 | dizziness |
light headed; soreness to site of injection; felt a random itch run along from my hand to up along m...
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light headed; soreness to site of injection; felt a random itch run along from my hand to up along my arm; some warmth to the site; This is a spontaneous report from a contactable other HCP (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer), intramuscularly on 23Dec2020 07:30AM at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Medical history included depression from an unknown date. No allergies to medications, food, or other products. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. Concomitant medication included fluoxetine. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. At the day of 23Dec2020 at 7:30 am the time of injection patient felt okay. She was let go to go back straight in to work. Once at work she felt light headed for 30 minutes with soreness to site of injection. Patient also felt a random itch run along from her hand to up along her arm. She applied lotion to the site if irritation for some comfort. The next 2 days patient still felt soreness and some warmth to the site. It's unknown if patient received treatment for the other adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The date report was first received from source was 27Dec2020. The events were reported as non-serious. No follow up attempts are possible; information about lot/batch number cannot be obtained.
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| 31 | 2021-01-04 | malaise, chills, fever |
sore arm (unable to lift without aching/hurting) for 2-3 days (improved each day, worst the day afte...
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sore arm (unable to lift without aching/hurting) for 2-3 days (improved each day, worst the day after vaccination) chills, low grade temp of 100.4F (went down with Tylenol), malaise, myalgia for one day starting the day after vaccination (Sunday evening and resolved by Monday morning)
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| 31 | 2021-01-05 | headache |
Arm soreness; headache; shakiness; nausea; diarrhea; This is a spontaneous report from a contactable...
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Arm soreness; headache; shakiness; nausea; diarrhea; This is a spontaneous report from a contactable other health professional reported for herself. A 31-year-old female patient (not pregnant at time of the report) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), intramuscularly on left arm on 30Dec2020 14:30 at single dose for COVID-19 immunization. Facility type Vaccine was reported as Doctor's office/urgent care. Medical history included SVT, neurocardiogenicy syncope, PVCS, known allergies: PCN. Concomitant medications were not reported. The patient experienced arm soreness, headache, shakiness, nausea, diarrhea on 31Dec2020. No treatment was received for the events. The outcome of the events were not resolved.
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| 31 | 2021-01-05 | fatigue, weakness, sweating, headache |
At 10 pm I started having severe body aches, fatigue, alternately feeling hot and cold, moderate hea...
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At 10 pm I started having severe body aches, fatigue, alternately feeling hot and cold, moderate headache, weakness, sweats
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| 31 | 2021-01-05 | throat pain |
At about 10 to 12 minutes after she received the vaccine she felt that her throat "felt numb" and ha...
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At about 10 to 12 minutes after she received the vaccine she felt that her throat "felt numb" and had trouble swallowing her own saliva. Approximately 30 minutes after the vaccine she noticed significant tongue and oral itching and then hoarseness. Vitals were normal. Did not notice any flushing, rash under skin or swelling. The symptoms all resolved after she received a dose of Benadryl (which she was able to swallow) followed by a dose of Zyrtec. 3 days after she received her injection she developed sore throat and body aches.
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| 31 | 2021-01-05 | dizziness |
Dizzy; Nausea; she broke out with what felt like a million bugs on her head and face, states it is b...
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Dizzy; Nausea; she broke out with what felt like a million bugs on her head and face, states it is burning and itching/burning and itching on face and head during hair appointment; felt bad/did not feel right all day; she broke out with what felt like a million bugs on her head and face, states it is burning and itching/burning and itching on face and head during hair appointment; there is a lot of paranoia; This is a spontaneous report received from a contactable consumer (who is also the patient). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration, on 28Dec2020, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. The patient stated she got the first dose of the Pfizer Covid vaccine on Monday, 28Dec2020. She mentioned that she read the list of side effects and all the print outs and stated her events were not on there. She wanted to make sure and stated maybe it was not even from the vaccine. She reported she just came from the hair dresser, had hair colored before many times, but today (30Dec2020), when she put the dye on her hair, she broke out with what felt like a million bugs on her head and face, stated it is burning and itching, maybe it is her imagination. She knows there is a lot of paranoia. She reported that she has had hair colored before and this has never happened, it occurred during hair coloring treatment. She also mentioned that on 30Dec2020 (also reported as "yesterday", pending clarification), she felt dizzy and nauseous; on 29Dec2020 (reported as "yesterday"), she felt bad and did not feel right all day, but says she knows those were listed symptoms. The outcome of the events dizziness, nausea, burning sensation and pruritus was recovering; the outcome of events paranoia and feeling abnormal was unknown.
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| 31 | 2021-01-05 | fever, weakness | Fever, nausea, muscle pain, weakness |
| 31 | 2021-01-05 | headache | Headache Narrative: Mild headache started 2 minutes after injection |
| 31 | 2021-01-05 | headache, fatigue, fever, chills |
I got my first dose of the Pfizer Covid vaccine on Saturday, 01/02/21, around 12:30 pm. About 12 hou...
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I got my first dose of the Pfizer Covid vaccine on Saturday, 01/02/21, around 12:30 pm. About 12 hours after I got the vaccine (around 1 am), I woke up with a headache, chills, body aches and a low grade fever. During the night, my temp got up to 99.9 and continued to stay around mid to high 99s throughout the day on Sunday. I tried Tylenol without any success and kept going in and out of chills with body aches and headache persisting. Before I went to sleep Sunday (01/03/21) night, I switched to Ibuprofen and woke up Monday morning without a fever but still experiencing fatigue. Throughout the day on Monday, fever did not return. I stayed home from work on Sunday and Monday. On Tuesday 01/04/20, I was still tired but able to return to work.
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| 31 | 2021-01-05 | chills, fever | fevers, chills, myalgias |
| 31 | 2021-01-05 | fatigue, headache |
headache; body aches; fatigue; still was feeling achiness in the arm and wrist; still was feeling ac...
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headache; body aches; fatigue; still was feeling achiness in the arm and wrist; still was feeling achiness in the arm and wrist; some tingling feeling in the fingertips or feet; This is a spontaneous report from a contactable pharmacist (patient). A 31-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date was unknown, via an unspecified route of administration on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if tingling in feet or fingertips a common adverse effect of the vaccine. The patient experienced headache, body aches, fatigue after receiving the shot. Yesterday at 6PM, she still was feeling achiness in the arm and wrist. She took Ibuprofen and started feeling some tingling feeling in the fingertips or feet. The outcome of the events was unknown. The following information on the lot/batch number has been requested.
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| 31 | 2021-01-06 | chills, fever | 12-13 hours post injection experienced low grade fever (100 degrees) chills and body aches |
| 31 | 2021-01-06 | cough, throat pain, fever, shortness of breath |
48 hours post vaccine I started having sore throat, cough, fever for the next three days. Later I go...
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48 hours post vaccine I started having sore throat, cough, fever for the next three days. Later I got tested positive. 5 days after vaccine I was experiencing SOB but all symptoms were gone after 10 days post injection. Not sure if I was exposed to people with covid prior to receiving the vaccine. I also do work with covid patients at work
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| 31 | 2021-01-06 | headache, chills | Body aches, chills, headache, skin burning. Took Tylenol. |
| 31 | 2021-01-06 | headache, chills, cough, fatigue, runny nose, throat irritation |
Day 1: nausea, severe stomach cramps, pain in the injection site Day 2: fatigue, tiredness, headache...
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Day 1: nausea, severe stomach cramps, pain in the injection site Day 2: fatigue, tiredness, headache, chills Day 3: fatigue, raised area, itching in the arm, pain in arm Day 4: nausea, diarrhea, itching in arm, raised bump at injection site, itchy throat, cough, runny nose
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| 31 | 2021-01-06 | dizziness, headache, chills |
Dizziness, Headache, Myalgia, RespDepression, Palpitations, arm soreness and discoloration, chills N...
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Dizziness, Headache, Myalgia, RespDepression, Palpitations, arm soreness and discoloration, chills Narrative
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| 31 | 2021-01-06 | headache, fever |
EE reports fever of 100.3, achy, muscle and joint pain, and HA. Treatment with Tylenol with no impr...
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EE reports fever of 100.3, achy, muscle and joint pain, and HA. Treatment with Tylenol with no improvement. She will continue to monitor.
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| 31 | 2021-01-06 | chills, fever |
Fever to 102.7F Rigors Nausea Myalgia All began morning after second vaccine and worsened through...
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Fever to 102.7F Rigors Nausea Myalgia All began morning after second vaccine and worsened throughout day
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| 31 | 2021-01-06 | fatigue, headache |
Headache, significantly muscle/body aches, joint pain, significant fatigue. Continual, intermittent ...
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Headache, significantly muscle/body aches, joint pain, significant fatigue. Continual, intermittent shooting abdominal pain.
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| 31 | 2021-01-06 | fatigue, chills, fever |
Muscle aches, joint pain, fatigue, nausea, chills, fever, delirium from fever. Symptoms lasted 22 ho...
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Muscle aches, joint pain, fatigue, nausea, chills, fever, delirium from fever. Symptoms lasted 22 hours.
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| 31 | 2021-01-06 | chills, fever, headache, fatigue | Myalgias, headache, chills, low grade fever, fatigue |
| 31 | 2021-01-06 | headache |
Painfully swollen axillary lymph nodes on side of injection, painfully swollen cervical lymph nodes ...
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Painfully swollen axillary lymph nodes on side of injection, painfully swollen cervical lymph nodes bilaterally, nausea, headache. Did not have any other symptoms and did not feel it warranted a dr appointment. Read the covid19 vaccine information sheet and saw all were known side effects. Resolved by 12/21/2020.
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| 31 | 2021-01-07 | fever, fatigue, headache, throat pain, shortness of breath, sweating |
All the covid symptoms - sore throat fever, headache; shortness of breath; no taste; fatigue; tested...
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All the covid symptoms - sore throat fever, headache; shortness of breath; no taste; fatigue; tested positive on the 23rd for Covid. 2nd dose: 1/6/2021 (received in right arm) - in am; adverse events started in the pm of the 6th: (6 Pm) - fever, chill, sweats, headache - all night into the following day for the headache; took tylenol LATE IN EVENING for fever and so no fever when I woke up 7th - took last night (7th) - still had chills and headache. (day two still) - HAS BEEN TAKING TYLENOL FOR24 HOURS BECAUSE HEADACHE IS BAD IF IT COMES ON day two - symptoms are better now; military - so was coming off covid protocol - so it complicated going back to work.
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| 31 | 2021-01-07 | dizziness, fatigue, migraine, malaise, cough |
First dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness and shakiness. 1...
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First dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness and shakiness. 12/24-30 Fatigue, malaise, soreness at injection site. 12/31-1/4 Migraines, increased fatigue and malaise, increased lightheadedness, body aches, intermittent dry cough. 1/5-1/8 decreased body aches, decreased fatigue, sustained lightheadedness.
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| 31 | 2021-01-07 | malaise, chills, fatigue, influenza like illness, fever |
Flu-like symptoms including low-grade fever to 100.8, rigors, malaise, fatigue, myalgias (full body,...
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Flu-like symptoms including low-grade fever to 100.8, rigors, malaise, fatigue, myalgias (full body, not just right deltoid vaccination site). Also painful and tender right axillary lymphadenopathy. Symptoms began the morning following the second vaccination in the series and have so far lasted for the full day. (Note: I am reporting the symptoms on the day I am experiencing them; they are improved from this morning but not yet resolved.) Notably I had no symptoms after the first vaccination in the series except for very mild transient tenderness of the right deltoid at the vaccination site.
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| 31 | 2021-01-07 | fatigue, fever, headache, chills |
Got the shot on 1/5/2021 around noon. In about 2 hours, started feeling soreness around the injectio...
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Got the shot on 1/5/2021 around noon. In about 2 hours, started feeling soreness around the injection area. After 14 hours of the shot, started feeling chill, whole body joint and muscle pain, headache, fatigue, 99.5 fever. on 1/6, took Tylenol every 6 hours, three times in total, 1950 mg total dose. helped. felt a lot better on 1/7, the second day after the shot but still took 2 tablets of Tylenol before went to bed. on 1/8, felt totally fine.
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| 31 | 2021-01-07 | fever, headache, chills |
Headache 24 hours after but nothing; uncontrollable/teeth chattering; chills; Fever; all over muscle...
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Headache 24 hours after but nothing; uncontrollable/teeth chattering; chills; Fever; all over muscle aches; Injection site is sore and surrounding area is red; Injection site is sore and surrounding area is red; This is a spontaneous report from a contactable Other HCP. This 31-year-old female Other HCP (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date was not reported) on 30Dec2020 at 11:00 AM (at the age of 31-years) as single dose, Intramuscular into right arm for immunization. Medical history included COVID-19 virus test positive from 30Nov2020 to an unspecified date. Allergies were reported as none. Concomitant medications included magnesium citrate, magnesium oxide, riboflavin, tanacetum parthenium (MIGRELIEF) and curcuma longa rhizome, piper nigrum fruit (TURMERIC +). On 31Dec2020 (00:45), patient experienced headache 24 hours after vaccine but nothing to keep her from my normal activities. About 36-40 hours post vaccine on 01Jan2021 patient awoke with uncontrollable/teeth chattering chills with 101 Fahrenheit (F) fever and muscle aches. Fever broke after taking Tylenol severe. Temp at 5:30AM back down to 98.5F. Temp creeping up again to 99.5F at 11AM. Injection site is sore and surrounding area is red on 01Jan2021. The patient is experiencing all over muscle aches. The patient received treatment and controlled the fever with Tylenol. Lab data included body temperature 101, 98.5, 99.5 Fahrenheit all in Jan2021. Events 'Headache', 'teeth chattering', 'chills', 'fever', 'muscle pain', 'muscle pain' and 'Injection site is sore and surrounding area is red' were recovering.
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| 31 | 2021-01-07 | shortness of breath, weakness, fatigue |
Heart palpitations, tachycardia, PVCs and shortness of breath, fatigue, weakness started on Monday ...
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Heart palpitations, tachycardia, PVCs and shortness of breath, fatigue, weakness started on Monday (1/4), worsened over next 2 days. Saw primary doctor on 1/7 who called paramedics to take me to the ER due to EKG results and increased work of breathing. ER doctor suspects mild guillain-barre reaction, I will be following up with cardiology and pulmonology as soon as possible as they were unable to determine exact cause or fix the issues.
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| 31 | 2021-01-07 | fever |
I had a fever of average 101.5 throughout the night and into the following morning. I also had one e...
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I had a fever of average 101.5 throughout the night and into the following morning. I also had one episode of vomiting at 11:40 pm on the same day I received the vaccine.
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| 31 | 2021-01-07 | malaise, fatigue, migraine, dizziness, cough |
I received my first dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness an...
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I received my first dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness and shakiness. 12/24-30 fatigue, malaise. 12/31-1/4 Increased fatigue and malaise, migraines, body aches, intermittent dry cough, lightheadedness, photophoibia. 1/5-1/8 Intermittent lightheadedness, slowly improving body aches.
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| 31 | 2021-01-07 | dizziness |
Lightheadedness x 3-4 hours until after eating a full meal; This is a spontaneous report from a cont...
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Lightheadedness x 3-4 hours until after eating a full meal; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received first dose of BNT162B2 (Pfizer product, lot number EK9231), intramuscular on 29Dec2020 16:30 at single dose on left arm for COVID-19 immunization. Medical history was none. The patient's concomitant medications included OTC Vitamins/Supplements. No allergies to medications, food, or other products. The patient experienced lightheadedness x 3-4 hours until after eating a full meal on 29Dec2020 16:30. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. No treatment received for the adverse event. The outcome of the event was recovered on an unspecified date.
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| 31 | 2021-01-07 | chills, fatigue | NauseaVomiting chiills, fatigue, nausea Narrative: phone call. |
| 31 | 2021-01-07 | dizziness |
Patient alerted pharmacist to feeling light headed at 12:10pm. Patient was instructed to sit down on...
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Patient alerted pharmacist to feeling light headed at 12:10pm. Patient was instructed to sit down on the floor. She stated she felt hot and hadn't eaten all day. She was given a few bites of apple sauce and some Dr. Pepper to drink in case of low blood sugar. She was also given 25mg of diphenhydramine in case of an allergic reaction after the vaccine adminstration at 12:15pm. A few minutes later, she began shaking and stated she thought she was having an anxiety attack. At this time, the patient requested we call 911 because that would make her feel better and so we did.
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| 31 | 2021-01-07 | dizziness |
Pt had reported feeling dizzy, then mouth swelling, and nausea. Pt was treated by ED staff after pr...
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Pt had reported feeling dizzy, then mouth swelling, and nausea. Pt was treated by ED staff after presenting back to vaccine clinic site. Pt received Epinephrine, Solu-medrol, and Benadryl, and is no longer experiencing any sxs.
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| 31 | 2021-01-07 | dizziness |
Pt recieved injection at 1000, began feeling dizzy around 1045, pts sxs continued to worsen with nau...
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Pt recieved injection at 1000, began feeling dizzy around 1045, pts sxs continued to worsen with nausea, and mouth swelling noted. Pt returned to the vaccine clinic and was escorted to the ED. In the ED she was evaluated by the provider, and given epinephrine, solu-medrol, and benadryl, and is now recovered from her reaction and being observed in the ED.
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| 31 | 2021-01-07 | fever, chills, headache | Rigors, Fever 102 degrees, headache |
| 31 | 2021-01-07 | headache, fatigue, chills, malaise |
STARTED AT 1AM 1/8/2021 WITH CHILLS, STRONG HEADACHE, MODERATE GENERALIZED MUSCLE PAIN, PAIN LEFT AR...
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STARTED AT 1AM 1/8/2021 WITH CHILLS, STRONG HEADACHE, MODERATE GENERALIZED MUSCLE PAIN, PAIN LEFT ARM WITH ABDUCTION. LOWER BACK PAIN, MALAISE AND FATIGUE
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| 31 | 2021-01-07 | fatigue, nasal congestion |
Sore arm, fatigue, feeling cold, sinus pressure and nasal congestion. Taking Tylenol and Benadryl, h...
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Sore arm, fatigue, feeling cold, sinus pressure and nasal congestion. Taking Tylenol and Benadryl, helping minimally .
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| 31 | 2021-01-07 | fatigue, headache |
Tiredness; Headache; Muscle pain; This is a spontaneous report from a contactable healthcare profess...
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Tiredness; Headache; Muscle pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the left arm on 02Jan2021 at 15:15 (at the age of 31-years-old) as a single dose for COVID-19 vaccination. There was no relevant medical history. Concomitant medications were unknown. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Jan2021 at 19:00, the patient experienced tiredness, headache and muscle pain. No treatment was provided for the events tiredness, headache and muscle pain. The outcome of the events tiredness, headache and muscle pain was not recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 31 | 2021-01-07 | sweating, fatigue | UrticariaPruritus sweating, fatique, lymph node swelling Narrative: |
| 31 | 2021-01-07 | dizziness, headache |
Vax given 12/30/2020 at 2030. Sxs developed later with nausea, vomiting, dizzyness, myalgias, headac...
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Vax given 12/30/2020 at 2030. Sxs developed later with nausea, vomiting, dizzyness, myalgias, headache. Presented to ED. IVF, Zofran/diphenhydramine inj, tylenol. Neg COVID-19 test.
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| 31 | 2021-01-07 | throat pain, fatigue, headache, dizziness |
diarrhea; headache; lower back pain; Fatigue; arrhythmia; Tachycardia; High Blood pressure; Redness ...
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diarrhea; headache; lower back pain; Fatigue; arrhythmia; Tachycardia; High Blood pressure; Redness on chest; Chest tightness; Lightheaded; possible tongue swelling; possible tongue swelling (felt heavy after vaccine); dry mouth; sore throat; This is a spontaneous report from a contactable nurse (patient) who reported for herself that a 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration, on 20Dec2020 14:15 at left arm/arm right (pending clarification), single dose for COVID-19 immunization. Medical history included factor II, history of melanoma. She has no known allergies. She was not pregnant at the time of the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), ibuprofen (MOTRIN), multivitamin. Nurse reported administering COVID-19 vaccine at hospital, experiencing tachycardia, high blood pressure, redness on chest, chest tightness, lightheaded, possible tongue swelling (felt heavy after vaccine), arrhythmia, dry mouth, sore throat (after leaving emergency department) at 14:30 on 20Dec2020; After one day, she experienced diarrhea, headache, lower back pain and fatigue since 21Dec2020. Fatigue lasting for several days. Adverse events resulted in emergency room/department or urgent care (pending clarification). Nurse received intravenous diphenhydramine hydrochloride (BENADRYL) and fluids as treatments. Nurse assessed the events as non-serious. Nurse also reported that, prior to vaccination, she was not diagnosed with COVID-19; since the vaccination, she has not been tested for COVID-19. She did not receive other vaccine in four weeks. Outcome of fatigue was not recovered, outcome of the rest of the events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the tachycardia, high blood pressure, arrhythmia and the other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 31 | 2021-01-07 | fever, chills, fatigue, dizziness, headache | fever, chills, body aches, extreme fatigue, headache, dizziness |
| 31 | 2021-01-07 | chills, fever | fever, chills, muscle aches |
| 31 | 2021-01-07 | headache, fever, chills | headache, fever, chills two days |
| 31 | 2021-01-07 | nerve pain, chills, malaise |
hyperthermia, tachycardia, chills, malaise, anxiety, sensitive skin/nerves, muscle and joint aches/p...
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hyperthermia, tachycardia, chills, malaise, anxiety, sensitive skin/nerves, muscle and joint aches/pains.
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| 31 | 2021-01-07 | headache |
nausea; slight headache; This is a spontaneous report from a contactable Other-HCP (patient). A 31-y...
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nausea; slight headache; This is a spontaneous report from a contactable Other-HCP (patient). A 31-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=Bl1284), intramuscular at Left arm on 04Jan2021 16:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included narcolepsy, cataplexy, anxiety. Concomitant medication included oxybate sodium (XYREM), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), doxepin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jan2021, received injection 2 hours later at 07:30 PM, the patient experienced nausea and slight headache. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.
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| 31 | 2021-01-07 | headache, body temperature increased, chills |
raised/bruised baseball marking at injection site; day 2: headache no medicine could get rid of, my ...
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raised/bruised baseball marking at injection site; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; baseball size red warm to touch welt; baseball size red warm to touch welt; temp; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; This is a spontaneous report from a contactable nurse, , the patient. A 31 -year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot_number: unknown), via an unspecified route of administration on 29Dec2020 at 11:30 AM, (at the age of 31 years-old) for COVID-19 vaccination. Medical history included Crohn's. The patient was allergic to adalimumab (HUMIRA). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020 at 08:00 PM, the patient had a baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills. On 30Dec2020 (reported as day 2), the patient experienced headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The patient was not treated for baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The clinical outcome of baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site was recovering. It was also reported that since the vaccination, the patient was been tested for COVID-19 (nasal swab) on 02Jan2021. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
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| 31 | 2021-01-08 | chills | Chills and shivering |
| 31 | 2021-01-08 | throat irritation, shortness of breath |
Developed a "scratchy throat approximately 20 minutes post vaccination. Symptoms worsened and she de...
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Developed a "scratchy throat approximately 20 minutes post vaccination. Symptoms worsened and she developed shortness of breath. Required evaluation and treatment in the Emergency Department. Received Benadryl, dexamethaxone, famotidine and solumedrol. Second COVID vaccine, no reaction with the first vaccine. ED provider notes below: This patient presented due to concern for allergic reaction to COVID-19 vaccine and was seen by myself immediately upon arrival. When in triage the triage nurse noted her oxygen saturation was 81% so she was placed on 2 L nasal cannula and brought directly back to her room. When placed in the room she was hooked up to the monitor and her oxygen saturation was 100% and I took her off of the nasal cannula and her oxygen saturation remained in the upper 90s. She had no stridor and respirations were nonlabored. She was speaking without difficulty and had no vocal changes. She did not appear to be in any acute distress. Her posterior oropharynx was widely patent and she had no uvula or tongue swelling or lip swelling. She did have some blotchiness to the upper chest area but no hives. Abdomen was soft and nontender. Pulse was regular. Blood pressure was stable. She was nontoxic in appearance. An IV was established and the patient was given Decadron and Benadryl for initial treatment.
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| 31 | 2021-01-08 | fever, fatigue, dizziness | Dizziness, Fever, fatigue, redness and swelling at injection site, Narrative: off work x 1 day; |
| 31 | 2021-01-08 | headache | Headache Narrative: Mild headache started 2 minutes after injection |
| 31 | 2021-01-08 | headache |
Received second dose of Pfizer vaccine. The next day had a mild headache and axillary lymph node swe...
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Received second dose of Pfizer vaccine. The next day had a mild headache and axillary lymph node swelling
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| 31 | 2021-01-08 | chills, skin warm |
Side effects started 12 hours after 2nd dose of vaccine (lot EL1284). I got chills, body aches, naus...
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Side effects started 12 hours after 2nd dose of vaccine (lot EL1284). I got chills, body aches, nausea, enlarged and swollen lymph node under left armpit that is warm to the touch and hurts.
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| 31 | 2021-01-09 | chills | Body aches, chills, joint pain and arm pain. Lasted for 10 hours roughly |
| 31 | 2021-01-09 | chills, migraine, fever | Chills, fever of 103, migraine |
| 31 | 2021-01-09 | headache, chills, fatigue, shortness of breath, weakness | Extreme fatigue/weakness, headache, chills, dyspnea, chest pain, body aches |
| 31 | 2021-01-09 | headache, chills, fatigue, fever | Fever 102.2F fatigue Chills Body aches Nausea Headache |
| 31 | 2021-01-09 | fever, headache, chills | Fever, chills, severe headache, extremely swollen lymph node under armpit of the arm vaccinated |
| 31 | 2021-01-09 | chills, fever |
First dose resulted in shoulder injury. Severe arm pain began evening after the first dose, followed...
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First dose resulted in shoulder injury. Severe arm pain began evening after the first dose, followed by pain in the shoulder joint when raising arms above head which has persisted for 23 days. Second dose resulted in fever, chills, nausea, swelling of hands and flushing sensation in hands/feet, with maximum fever of 100.2 F documented 24 hours after the second dose. Fever and chills resolved about 36 hours after the injection.
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| 31 | 2021-01-09 | fever, headache, chills |
Headache - 10 hours after receiving lasted a couple hours subsided with ibuprofen Fever- highest 101...
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Headache - 10 hours after receiving lasted a couple hours subsided with ibuprofen Fever- highest 101.3 on 1/9/2021- had fever/chills from 1/8/2021-1/9/2021- subsided with ibuprofen but would come back up after several hours. Nausea- started 1/8/2021 through 1/10/2021 Vomiting- started 1/8/2021 through 1/10/2021- not able to keep any foods/ drinks down with the exception of water. Tried BRAT foods and still vomited within 10-15 mins of eating.
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| 31 | 2021-01-09 | dizziness |
Noticed burning in left forearm immediately after vaccine, within 1 min. Symptoms progressed to feel...
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Noticed burning in left forearm immediately after vaccine, within 1 min. Symptoms progressed to feeling hot, flushed, and tachycardia briefly around 5 min. 10 min developed a pressure in my chest, and dizziness. Within 20 min, developed itching, flushing and hives specifically on left arm, hand, and across chest. Within 45 min, both ears and forehead covered with hives. Hospital staff made me go to ED. Within ED hives continued to progress across the chest and bilateral arms and wrists. Received 50mg of Benadryl, and 40mg of prednisone. Symptoms improved but did not resolved. 3 hrs following vaccine, bilateral lip swelling. Took 40mg of percribed pred and 25mg of Benadryl again around 4pm. Within 12 hrs, significant diarrhea. Hives resurfaced on face, bilateral wrists, arms, and ears around 645 on the 12/29. Fever 100.3 noted on 12/29-12/30. Intermitted hives, and lip swelling remained until 1/1. Nausea diarrhea and body aches until 1/2.
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| 31 | 2021-01-09 | headache | Pfizer-BioNTech COVID-19 Vaccine Nausea, diarrhea, myalgias, cephalgia |
| 31 | 2021-01-09 | chills, fever, fatigue, somnolence |
Right after the second dose less than 2 minutes my heart rate began to spike. I could feel my heart ...
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Right after the second dose less than 2 minutes my heart rate began to spike. I could feel my heart pumping fast. I couldn?t sit due to this so I began pacing the room. I didn?t know this was a side affect so I thought I was over thinking the second dose. I attributed this to all the worry and doubt the media and people around me try pumping in your head. I thought I was having a panic attack. I didn?t alert any of the medical team there because again, I thought I was over thinking it. A few hours later my heart rate had gone down. My Apple Watch helped me monitor this. The next day I felt pain at the injection site, not my normal self, groggy. Slightly feverish and chilled. I work in a cold environment so I couldn?t quite tell if the chilled feeling was a side effect, or the room. Later that evening around 9pm things took a turn. I began running a low grade fever and was shaking from being so cold. About another hour late my fever was up to 101 and I was still shaking from being so cold. I took about 600mg of ibuprofen. I couldn?t sleep, tossed and turned. Probably another hour later my temperature was 102, still shaking uncontrollably. Covered in about 5 blankets I kept waiting it out. And I?d say around 2-3am I could feel my fever breaking. By late morning my temp was back to normal but I felt achy still. Tired, sore. Definitely sore at my injection site. And I don?t know if this is worth mentioning or not but just haven?t been able to shake that panic attack feeling. Like a worry or a dread over me. I just don?t feel as clear-headed as I did before. This is my biggest concern. Just don?t feel myself yet.
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| 31 | 2021-01-09 | sweating, shortness of breath, chills, fever |
Woke in middle of night (2am approx. 12hrs post vax) with palpitations, HR 120s, SOB, fever 100.8, s...
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Woke in middle of night (2am approx. 12hrs post vax) with palpitations, HR 120s, SOB, fever 100.8, sweats, chills, body/joint aches. Palpitations and SOB persisted for approx 4hrs, off and on. Fever 100.2 and body aches persisted until approx. 5pm the day after 2nd vax (approx 27hrs).
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| 31 | 2021-01-09 | malaise, dizziness | nausea, feeling flushed, dizzy evaluated by EMTs - VSS and wnl employee continued to feel unwell |
| 31 | 2021-01-09 | fatigue, headache, chills |
vaccine on 1/7 around 1130am. Onset of severe chills/shaking, fluctuating temperature (no fever), ho...
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vaccine on 1/7 around 1130am. Onset of severe chills/shaking, fluctuating temperature (no fever), horrible aches and pains, significant fatigue, and persistent headache from about 3am the morning after (on 1/8) and lasting until bedtime that day. The next morning (1/9), most symptoms had resolved except for fatigue. I also experienced a new sx: severe pain and tightness in my chest/torso; was hard to breath normally and could not take a deep breath without experiencing significant pain. This lasted until about 3pm. Fatigue persisted the rest of the day. All symptoms had resolved by the next morning (1/10).
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| 31 | 2021-01-10 | influenza like illness, malaise, dizziness, fatigue |
- Sore shoulder for 2 days - overall body aches (comparable to the flu) for 2 days - malaise (Saturd...
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- Sore shoulder for 2 days - overall body aches (comparable to the flu) for 2 days - malaise (Saturday I went to bed at 7pm and woke up at 6am Sunday morning still feeling tired - unusual for me) - light/swimmy headed for 2 days - decrease in appetite for 2 days Worst was on Saturday and Sunday was a little better. Asymptotic by Monday morning
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| 31 | 2021-01-10 | weakness, chills, discomfort, dizziness, malaise, fatigue, fever |
0830 1/7/21 experienced rapid onset lightheadedness that lasted for a duration of 15 minutes before ...
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0830 1/7/21 experienced rapid onset lightheadedness that lasted for a duration of 15 minutes before resolving. From 0900 to 1600 experienced fatigue and heaviness that prevented me from working that day. From 1600 to 2000 I felt "normal". At 2100 I went to bed with chills and overall malaise, awoke at 0000 1/8/21 with a fever of 101 F. Throughout the night I experienced severe body aches and a headache that made my teeth and jaw ache 7/10 on the pain scale. Tylenol 500mg taken at 0500 1/8 with relief. Fatigue/weakness experienced until 1700 on 1/8/21 after which I felt like myself again. In total, 2 days of work missed as a result of symptoms.
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| 31 | 2021-01-10 | chills, fever |
2nd dose I began having muscle aches around 10pm (about 10 hours post 2nd dose) then I woke up in t...
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2nd dose I began having muscle aches around 10pm (about 10 hours post 2nd dose) then I woke up in the night at 1am ( about 13 hours post injection) with a fever of 101.4, muscle aches (my legs, arms, neck, and back), chills, and sinus dryness. This was controlled 3 hours later by tylenol. For the next 36 hours post symptom onset my sinuses were still affected, my muscles felt very weak and the glands in my neck felt swollen. Everything has resolved except the swollen glands in my neck and my sinsuses being dry and painful.
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| 31 | 2021-01-10 | dizziness, chills |
2nd dose: Sore at site of injection left arm 5-6 hrs after injection. 6 AM body aches, chills and di...
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2nd dose: Sore at site of injection left arm 5-6 hrs after injection. 6 AM body aches, chills and dizziness, symptoms are resolving at time of reporting 1 dose: only soreness at site of injection few hrs
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| 31 | 2021-01-10 | fatigue, fever |
Acute Onset of tachycardia. Resolved within 5 minutes following injection. Accompanied fatigue and f...
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Acute Onset of tachycardia. Resolved within 5 minutes following injection. Accompanied fatigue and feverish symptoms 1 day post vaccination, resolved by day 3.
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| 31 | 2021-01-10 | chills, dizziness |
After 24 hours of receiving vaccine my lower back started to ache, I experienced body chills and my ...
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After 24 hours of receiving vaccine my lower back started to ache, I experienced body chills and my skin was sensitive to touch. This lasted for about 6 hours. I was also light headed and woozy for about 3 hours. The next morning all of these symptoms were gone.
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| 31 | 2021-01-10 | headache |
Daily Headaches (no change in sleep, exercise, or other routine; no change in diet, medications, etc...
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Daily Headaches (no change in sleep, exercise, or other routine; no change in diet, medications, etc in that time)
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| 31 | 2021-01-10 | chills, dizziness | Dizziness, light headedness, nausea, chills |
| 31 | 2021-01-10 | fever | Fever gone after 24 hours |
| 31 | 2021-01-10 | headache, fatigue |
Headache 24 hours started 1 hour after vaccine Fatigue 6 hours after vaccine lasted until 1/11 so ar...
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Headache 24 hours started 1 hour after vaccine Fatigue 6 hours after vaccine lasted until 1/11 so around 48 hours after vaccine.
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| 31 | 2021-01-10 | chills, headache, dizziness, fatigue | Hot flashes Cold chills Headache Body aches Fatigue Dizziness |
| 31 | 2021-01-10 | somnolence, chills, migraine, dizziness, headache |
I felt flushed and light headed after receiving the vaccine but as the day went on I felt worse. By ...
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I felt flushed and light headed after receiving the vaccine but as the day went on I felt worse. By 2030 I had severe full body chills and could not stop shaking. I had a severe headache/migraine. Every muscle in my body hurt. This continued on for the entire night. Got tested for COVID the next morning with the rapid results and the symptoms continued with the muscle aches and severe headache. Vision became blurry and I became very dizzy. Slept for 8 hours during the day on 1/7/2021 and then slept another 12 hours that night. The body aches and headaches continued until 1/8/2021 at which the symptoms finally subsided
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| 31 | 2021-01-10 | fatigue |
I got fatigue a few hours after vaccine and resolved after a nap of 3 hours. My arm also still has ...
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I got fatigue a few hours after vaccine and resolved after a nap of 3 hours. My arm also still has soreness at the injection sight when touch and area around my underarm hurts with movement.
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| 31 | 2021-01-10 | fatigue, headache |
I had tachycardia about 18 hours following my second dose. It lasted a few hours before subsiding. I...
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I had tachycardia about 18 hours following my second dose. It lasted a few hours before subsiding. I had this along with aches, headache and fatigue which I expected but the tachycardia was pretty significant. Up and walking to the bathroom HR was in 130s, laying down it was in the 110s.
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| 31 | 2021-01-10 | fatigue |
Received second Pfizer covid vaccine. Felt extremely fatigue, joint pain, and pain in the injection ...
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Received second Pfizer covid vaccine. Felt extremely fatigue, joint pain, and pain in the injection site Friday night at work. Saturday night felt extremely fatigue.
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| 31 | 2021-01-10 | headache, chills, fever |
Started with aches and chills, progressed to being very hot and having a 99.5 fever, then had linger...
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Started with aches and chills, progressed to being very hot and having a 99.5 fever, then had lingering headache. Arm was very very sore and painful. All symptoms disappeared next day.
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| 31 | 2021-01-10 | weakness |
The patient developed numbness in her left leg then shortly later numbness in her right arm affectin...
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The patient developed numbness in her left leg then shortly later numbness in her right arm affecting her balance and ability to walk accompanied by generalized weakness.
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| 31 | 2021-01-10 | shortness of breath |
The patient experienced dyspnea and chest tightness several minutes after receiving the shot. She d...
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The patient experienced dyspnea and chest tightness several minutes after receiving the shot. She did not notify anyone, and after her 15 minute wait, she went home. Her respiratory symptoms worsened despite taking a dose of diphenhydramine. At the urging of her family, she went to the ER four hours later, where she was evaluated. No treatment was done, and she was told that she was having a mild reaction. Her symptoms resolved after several hours.
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| 31 | 2021-01-10 | nerve pain |
Three and a half days after the vaccine experienced nerve pain in my legs. Went into the ER was admi...
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Three and a half days after the vaccine experienced nerve pain in my legs. Went into the ER was admitted for observation. Is getting better day to day.
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| 31 | 2021-01-10 | weakness, fatigue |
Woke up the next morning super weak and nauseous. Had little energy and no appetite. Slept most of t...
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Woke up the next morning super weak and nauseous. Had little energy and no appetite. Slept most of the day. Friday (3 days after) felt tired and weak.
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| 31 | 2021-01-10 | chills, fever | body aches chills fever |
| 31 | 2021-01-10 | headache, fatigue | day 1 fatigue, sore arm day 2 more fatigue, extra sore arm, head ache |
| 31 | 2021-01-10 | headache, weakness |
it was debilitating for her at work; It even hurts to move the right eye in one direction and hurts ...
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it was debilitating for her at work; It even hurts to move the right eye in one direction and hurts to speak, the pain was so bad.; pain in right leg and bottom sole of right foot; hurts to speak; numbness right upper side of lip; pins and needle feeling right upper quadrant of face; pain and dull aching right upper side of face; right hand numbness, wasn't able to feel anything; generalized headache; generalized muscle weakness and pain; generalized muscle weakness and pain; This is a spontaneous report from a contactable other hcp (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 at single dose in deltoid right for covid-19 immunization. There were no medical history or concomitant medications. The patient received the vaccine on 03Jan2021 and within 15 minutes had a generalized headache. Later that night she had generalized muscle weakness and pain, but really didn't think too much about it. The next day at work (04Jan2021), she had numbness on the right upper side of her lip and a pins and needle feeling in the right upper quadrant of the face. Had a lot of pain in the area as well on the right upper side of the face as well as a dull aching pain that lasted for hours. Later that day when using the computer and she was trying to reach for her mouse she noticed her right hand wasn't able to feel anything and that lasted about 20-25 minutes. Kept slapping the mouse with her hand, but could not feel anything, her hand went numb. Yesterday (05Jan2021), she had the same pins and needle feeling in the same area of the face and that dull achy feeling and it occurred for hours and it was very kind of debilitating for her at work. Later that night she had pain in her right leg and felt the same way, that very severe achiness, which was the pins and needles feeling up and down the leg and underneath the right foot. All these symptoms tend to be on her right side and it definitely lasted for hours. It started about 1 and didn't end until 6-7pm. It even hurts to move the right eye in one direction and hurts to speak, the pain was so bad. This morning (06Jan2021) she had to call out of work because at 3am the generalized headache, pain was unbearable. She was still experiencing the pain in right leg and bottom sole of right foot. She did not receive any vaccines the same day or 4 weeks prior. No problems with vaccines in past. She had made an appointment with a neurologist and will have a MRI done on Friday, 08Jan2021. No further details provided. All events required a visit to physician office. All events were reported as serious per medically significant. The outcome of all events was not resolved. The reporter considered all events were related to the vaccine. Information about Lot/Batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 31 | 2021-01-11 | chills, fever, headache |
About 6-7 hours after receiving the second Pfizer COVID-19 vaccine, I had the onset of headache, vom...
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About 6-7 hours after receiving the second Pfizer COVID-19 vaccine, I had the onset of headache, vomiting, fever to 101, chills, rigors, and diffuse body aches. The symptoms improved with ibuprofen and tylenol. They resolved within 24 hours so about 36 hours post-vaccine.
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| 31 | 2021-01-11 | fever, malaise, headache |
All symptoms started around 12 hours after the vaccine and peaked at 18 hours: Fever 103f, body ache...
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All symptoms started around 12 hours after the vaccine and peaked at 18 hours: Fever 103f, body aches, malaise, severe headache, injection site pain, loss of appetite
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| 31 | 2021-01-11 | fatigue, headache |
Fatigue starting 12 hours after receiving vaccine. 24 hours after vaccine experienced mental fog, jo...
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Fatigue starting 12 hours after receiving vaccine. 24 hours after vaccine experienced mental fog, joint pain, muscle pain, headache and nausea.
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| 31 | 2021-01-11 | fatigue, chills, headache | Neck pain, chills, headache, excessive fatigue, no appetite |
| 31 | 2021-01-11 | head discomfort, night sweats, headache |
On 12/25 I was driving home and my left arm got numb, tingly and weak to the the point where I thou...
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On 12/25 I was driving home and my left arm got numb, tingly and weak to the the point where I thought I was suffering from a stroke. I rushed to my moms and had her to drive me to the hospital where they did a neuro check to include a CT scan which ruled out the stroke but the symptoms lasted about 4 days which came and went with the pain and intensity varying each time which ended around 12/29. I suffered from body aches and night chills one night. Around the 12/29 I began to have pressure around the back of my head which felt as if I was laying on bricks when I laid down. It got to the point to where I couldnt sleep which caused me to go back to the ER on 1/1 where I was given toradol, decadron and sudafed which allowed me to sleep. I was released from the ER with Motrin 800 and contined to take that and Tylenol until the headaches ceased which was about 3 or 4 days later. The headache went away but the pressure still remained. My lymph glands were swollen so I was also given a prescription for amoloxicillin.
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| 31 | 2021-01-11 | fever, chills |
Pfizer-BioNTech COVID-19 Vaccine EUA Instructions to report effects after receiving COVID-19 vaccine...
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Pfizer-BioNTech COVID-19 Vaccine EUA Instructions to report effects after receiving COVID-19 vaccine. Symptoms of severe chills, muscle aches, fever, rapid heart rate, nausea, diarrhea all lasting 48hrs with nausea continuing thereafter. No treatment. Continued nausea, however otherwise recovered
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| 31 | 2021-01-11 | dizziness | Prolonged tachycardia, light headed |
| 31 | 2021-01-11 | throat pain |
Recipient reported a sore throat and an upper body rash on the neck area and parts of the face that ...
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Recipient reported a sore throat and an upper body rash on the neck area and parts of the face that eventually faded.
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| 31 | 2021-01-11 | chills | Severe Chills and Nausea |
| 31 | 2021-01-11 | fever, headache |
low grade fever x 6 hours severe body aches x 24 hours severe heartburn x 12 hours low grade headach...
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low grade fever x 6 hours severe body aches x 24 hours severe heartburn x 12 hours low grade headache x 4 days
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| 31 | 2021-01-12 | chills, throat swelling |
After my first dose, the only symptom I had was soreness at the injection site lasting 1 day. 12 hou...
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After my first dose, the only symptom I had was soreness at the injection site lasting 1 day. 12 hours after my second vaccine, I developed muscle aches and chills that were gone the following morning when I woke up. 3 days after receiving my second dose, I developed hives and swelling on my entire body that progressed over 2 days. I also started to have some swelling in my throat by 4 days after the second dose and ended up going to immediate care for a steroid injection which began to provide relief by the next morning.
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| 31 | 2021-01-12 | fever, chills | CHILLS, FEVERISH, CHEST PAIN, MUSCLE ACHES, SWELLING IN LEFT SIDE OF NECK, NECK PAIN |
| 31 | 2021-01-12 | fever, headache, chills | Chills, fever, headache, body aches, |
| 31 | 2021-01-12 | somnolence |
Client administered 0.3 mL Pfizer COVID19 vaccine via IM to left arm at apx 1525. At apx 1545 clie...
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Client administered 0.3 mL Pfizer COVID19 vaccine via IM to left arm at apx 1525. At apx 1545 client verbalized complaint of tingling sensation to lips and face. Client denied any difficulty breathing. Client administered 50mg of Diphenhydramine via IM to right arm at apx 1546. 1547 BP= 117/70; HR = 98bpm; RR = 18; temp = 97.2. Client verbalized tingling sensation lessening at apx 1550. 1552 BP = 113/69; HR = 92; RR = 15; temp = 97.2 At 16:00 client verbalized tingling sensation had completely subsided. Client denied any difficulty breathing. Client declined transport to ED and instead called friend to pick her up as she was too drowsy to drive per Dr.
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| 31 | 2021-01-12 | fever, chills, malaise |
Extreme malaise, chills, fever of 100 degrees, gi discomfort, diarrhea. Slept for 16 hours and had t...
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Extreme malaise, chills, fever of 100 degrees, gi discomfort, diarrhea. Slept for 16 hours and had to call out of work following day. Symptoms lasted for 24 hours. I took Tylenol 500mg on 1/8 for fever.
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| 31 | 2021-01-12 | fatigue | Fatigue Nausea |
| 31 | 2021-01-12 | headache, chills, fatigue | Fatigue, body ache, chills, nausea, headache. Resolved. |
| 31 | 2021-01-12 | fatigue, fever, chills | Fatigue, fever, chills, body aches, joint pain, skin hurting |
| 31 | 2021-01-12 | fatigue, chills |
Fatigue; chills; nausea; vomiting; This is a spontaneous report from a non-contactable other health ...
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Fatigue; chills; nausea; vomiting; This is a spontaneous report from a non-contactable other health professional. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm, from 30Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included anxiety and intermittent SVT (supraventricular tachycardia). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Concomitant medication included escitalopram and buspirone for anxiety. On 01Jan2021 19:00, the patient experienced fatigue, chills, nausea and vomiting. The outcome of events was recovered. No treatment was required/received due to the events. No follow up attempts are possible. Information about lot/batch number cannot be obtained.
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| 31 | 2021-01-12 | headache, chills, fever, fatigue | Fever (100.5) Chills Headache Loss of Appetite Fatigue Muscle aches |
| 31 | 2021-01-12 | headache, fever, fatigue, chills | Fever,chills, body ache, headache, fatigue, near syncope |
| 31 | 2021-01-12 | somnolence, fatigue, malaise, throat pain |
I've felt like I have the flu for the past 3 days; aches/pains; sore throat; sinus pressure; extreme...
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I've felt like I have the flu for the past 3 days; aches/pains; sore throat; sinus pressure; extreme fatigue; sleeping most of the day making it hard to work; feeling worse, not better; fogginess; This is a spontaneous report from a contactable Other-HCP (patient herself). This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 04Jan2021 at 08:00 at 0.3 ml single for COVID-19 immunisation. The patient was not pregnant. Vaccine location was left arm. Relevant medical history included depression, anxiety, endometriosis. No known allergies. Relevant concomitant medications included bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), and colecalciferol (VITAMIN D). The patient was vaccinated at Workplace clinic, age at vaccination was 31-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. The patient stated that on 05Jan2021 ''I've felt like I have the flu for the past 3 days-aches/pains, sore throat, sinus pressure, fogginess, extreme fatigue; I'm sleeping most of the day making it hard to work; feeling worse, not better, each day; trying OTC meds- loratadine pseudoephedrine sulfate (CLARITIN D) and chlorphenamine maleate, paracetamol, pseudoephedrine hydrochloride (TYLENOL COLD); plan to call doctor if not feeling better by day 5''. The patient had not recovered from the events. No follow-up attempts are possible. No further information is expected.
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| 31 | 2021-01-12 | body temperature increased, malaise, chills, fatigue |
Pain at injection site, Arm soreness starting at time of injection , elevated temp 99F with mild ...
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Pain at injection site, Arm soreness starting at time of injection , elevated temp 99F with mild chills, fatigue and malaise starting the following morning lasting about 8 hours.
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| 31 | 2021-01-12 | skin warm |
Patient had sudden onset of flushing/erythema of skin (no pruritus, but warm to touch), diaphoresis,...
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Patient had sudden onset of flushing/erythema of skin (no pruritus, but warm to touch), diaphoresis, and itchy throat. She denies shortness of breath or any respiratory problems. Symptoms started 20 min prior to arrival at the Emergency Department. When the patient arrived at the ED, all of her signs and symptoms had started to subside.
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| 31 | 2021-01-12 | fatigue |
Patient started to have a local injection site reaction on 1/10/21 at around 9:10am. The injection s...
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Patient started to have a local injection site reaction on 1/10/21 at around 9:10am. The injection site had some redness and swelling. By the afternoon on 1/10/21 the red and swelling increased and by 1/12/21 the redness was the size of a half dollar and swelling just beyond the redness. The area is warm to touch. Pt also had symptoms of nausea, fatigue, and muscle pain. Pt was instructed to take Zyrtec BID & pepcid. When I talked to the patient on 1/13/2021, the injection site remains the same and still feels nauseated.
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| 31 | 2021-01-12 | body temperature increased |
Pt developed post COVID vaccine side effects at 1000. Pt received COVID vaccine at 0932 by LVN. ...
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Pt developed post COVID vaccine side effects at 1000. Pt received COVID vaccine at 0932 by LVN. Pt complained of a numb throat, and said, "I cant seem to swallow my saliva well." This writer did an immediate assessment of patient's throat with flashlight, and no swelling, abnormal discharge, or discoloration noted. Pulse-ox that was available on hand was used on pt, and sats were 96% and HR 78. MA on site was asked to grab a complete VS machine for somewhere stat, for there was none on site. This writer reassured pt was going to be okay and to breathe normally, for assessed pt was breathing fast. This writer called every doctor listed on the "Contact List for COVID Vaccine Clinic," but there was no response. This writer then called Urgent Care and Minor Injury Clinic, but the doctors were busy with patients. Asked MAs from those areas to have a doctor call immediately for a patient here was symptomatic. Once VS got here, VS were taken, and pt was assessed again. Pt said there was no more numbness in her throat, but tongue was feeling itchy, and her body temp went from hot to cold. Intitial VS: Temp: 98.3 BP: 122/80 HR: 77 O2: 99% RR: 18 Dr from Urgent Care finally called. Background story given, and she ordered Diphenhydramine Cap 25mg (Benadryl) which this writer had on hand in the emergency kit. Order was on computer, but could not acknowledge or scan, so order detail was printed, and pt and I signed form together. Benadryl given at 1025. Dr also suggested that ID doctor be called. At 1030, I got a hold of Dr., gave her a background story, and she advised that the pt stay for another 30 mins to be observed and she would come see the pt. Dr. arrived at 1100, assessed the patient, and ordered Cetrizine Tab 10mg (Zyrtec) to give to pt, which Dr. had to get from another department. There was no Zyrtec available in emergency kit. Again, order was on computer, but could not acknowledge or scan, so order detail was printed, and pt and I signed form together. Zyrtec given at 1128. An additional Zrytec Tab 10mg was given at same time at 1128 "for home use" per Dr and per her order. VS set #2 taken at 1133 Temp: 98.1 BP: 133/94 HR: 63 O2: 100% RR: 16 Dr suggested that she schedule an appt to see an allergist and to get an allergy test done prior to the next dose of the COVID vaccine. Patient was feeling a lot better and more at ease. Pt left comfortably with no symptoms at 1200.
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| 31 | 2021-01-12 | throat irritation |
RASH ON ARMS AND LEGS THAT WHEN AWAY WITH BENADRLY , RETURNED THE NEXT DAY AND PERSISTED., SEEN IN e...
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RASH ON ARMS AND LEGS THAT WHEN AWAY WITH BENADRLY , RETURNED THE NEXT DAY AND PERSISTED., SEEN IN ed EMPLOYEE HAS PURRITIS IN THROAT, THRATED WITH BENADRLY.
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| 31 | 2021-01-12 | fatigue, chills, headache |
Received 2nd dose of Covid vaccine yesterday. Woke up at 4AM with chills, a mild headache, and arm p...
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Received 2nd dose of Covid vaccine yesterday. Woke up at 4AM with chills, a mild headache, and arm pain. Ibuprofen helped to relieve symptoms. Still feels chills, arm pain, and now fatigue.
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| 31 | 2021-01-12 | dizziness, headache, fever, shortness of breath, fatigue |
Side effects: headache, joint pain, muscle aches, fever, dizziness, nausea, shortness of breath, fat...
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Side effects: headache, joint pain, muscle aches, fever, dizziness, nausea, shortness of breath, fatigue
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| 31 | 2021-01-12 | fever, fatigue |
So on the night of the 25th, my lymph nodes were so swollen, my left eye was twitching, low grade fe...
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So on the night of the 25th, my lymph nodes were so swollen, my left eye was twitching, low grade fever that was constant from Friday through Sunday. My left leg was twitching and also my left bicep. I had left sided twitching that was off and on. I had fatigue and some aching in my knees.
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| 31 | 2021-01-12 | skin warm |
Spot on arm, just below injection site. Red, warm, tender, round with irregular border. In first 48h...
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Spot on arm, just below injection site. Red, warm, tender, round with irregular border. In first 48hrs after second vaccine, sane arm was sore and stiff. No other side effects/reactions noticed until red spot.
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| 31 | 2021-01-12 | fever, malaise, headache, chills |
Took Advil and symptoms were relieved. Chills, fever, headache, injection site pain, malaise, new o...
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Took Advil and symptoms were relieved. Chills, fever, headache, injection site pain, malaise, new or worsened joint and muscle pain
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| 31 | 2021-01-12 | fatigue, chills, fever | chills. body aches, low grade fever, fatigue, |
| 31 | 2021-01-12 | headache, chills | slight nausea and chills. Severe Headache |
| 31 | 2021-01-13 | chills, night sweats, body temperature increased, headache, fatigue, weakness, dizziness |
01/08/21 received the vaccination, am of 01/09/21 woke up with headache, body aches, chills, took Ex...
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01/08/21 received the vaccination, am of 01/09/21 woke up with headache, body aches, chills, took Excedrin and ibuprofen, worked all day and by the end of the shift started feeling worse. Symptoms to include : shaky, felt like she was freezing to death but no fever at this point, skin felt like it was on fire, Around 8:00pm temp of 100PO at this time took 1000mg Tylenol and when she had got the shower skin was very sensitive to the water and felt like it was hot, but the water was not, by 10:00 pm temp of 103, felt shaky, achy all over, dizziness/nausea, muscle weakness, fatigue. Went to bed that night, had night sweats during the night. 01/10/21 got up around 4:30am to get ready for work, continued with severe muscle weakness, shaky, headache, got in shower and fell from being so weak and tired. Gradually through the day got better, had went back to bed that morning and slept almost all day and by 3:00pm -4:00pm was feeling much better.
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| 31 | 2021-01-13 | cold sweat |
1104 a.m. felt shaky, lightheaded, funny feeling in her chest; moved to 30 min observation status; ...
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1104 a.m. felt shaky, lightheaded, funny feeling in her chest; moved to 30 min observation status; 1105 a.m. BP 142/92, P 128, Resp 18, SpO2 99%; A&O x 3; skin cool and clammy; resp/lungs clear and unlabored; EMS called; Moved to gurney; juice given. Pt has hx of Hashimoto's 1110 a.m. BP 136/100, P 100, R 18, SpO2 91%; A&O x 3; skin cool and dry; remains shaky; resps unlabored; EMS arrived; Care handed off to emergency crew and taken to hospital.
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| 31 | 2021-01-13 | headache, fatigue, dizziness, chills | Continued Headache, dizziness, swollen lymph nodes, fatigue, chills, body aches |
| 31 | 2021-01-13 | headache, fatigue, fever |
Fever (99.7) body aches, HA, mild diarrhea, fatigue started midnight, symptoms improved with Tylenol...
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Fever (99.7) body aches, HA, mild diarrhea, fatigue started midnight, symptoms improved with Tylenol.
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| 31 | 2021-01-13 | chills, fever |
Fever 100; injection site pain; Moderate body aches; Chills; This is a spontaneous report from a con...
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Fever 100; injection site pain; Moderate body aches; Chills; This is a spontaneous report from a contactable nurse (patient). A 31-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 07Jan2021 10:30 at single dose in left arm for covid-19 immunization. Medical history included asthma and depression. The patient had no allergies to medications, food, or other products. Concomitant medications the patient received within 2 weeks of vaccination included celecoxib (CELEXA) and bupropion. The patient previously received her first dose of bnt162b2 on 18Dec2020 15:00 at the age of 31-years in her left arm for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced moderate injection site pain, moderate body aches, chills and fever 100 on 07Jan2021 22:00. The patient was not received any treatments for the adverse events. The outcome of the events was not recovered. Information about lot/batch number has been requested.
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| 31 | 2021-01-13 | chills, fever, headache, dizziness |
Mild headache upon waking up, progressively worsening throughout the day, mild lightheadedness, chil...
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Mild headache upon waking up, progressively worsening throughout the day, mild lightheadedness, chills, low-grade fever, and brain fog began at approx. 10:00 AM and gradually worsened as day progressed. Symptoms completely resolved as of 8:00 AM 1/10/2021.
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| 31 | 2021-01-13 | headache |
TWO DAYS OF SINTOMOS,PAIN INJECTION SITE, HEADACHE,MUSCULAR PAIN,FEVER,ABDOMINAL PAIN, DIARREA,SUETI...
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TWO DAYS OF SINTOMOS,PAIN INJECTION SITE, HEADACHE,MUSCULAR PAIN,FEVER,ABDOMINAL PAIN, DIARREA,SUETING AND INFLAMATION OF THE GANGLIOS.
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| 31 | 2021-01-13 | headache, fever |
covid a week after the1st dose of the vaccine. When to get the 2nd dose?/tested positive for COVID; ...
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covid a week after the1st dose of the vaccine. When to get the 2nd dose?/tested positive for COVID; covid a week after the1st dose of the vaccine. When to get the 2nd dose?/tested positive for COVID; body aches; fever; Headache; This is a spontaneous report from a contactable physician. A 31-year-old female patient (healthcare worker) received the 1st dose of bnt162b2 (BNT162B2) at single dose in Dec2020 (9 days before 07Jan2021) for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the 1st dose of the COVID vaccine 9 days before 07Jan2021 and got a headache afterward in Dec2020. After 6 days, in Jan2021 the patient had a worse headache, body aches, and fever. She was swabbed for COVID on 06Jan2021 and tested positive. The reporter wanted to know what to do about the 2nd dose. The outcome of events was unknown. A product complaint was filed. information about lot and batch number was requested.
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| 31 | 2021-01-13 | fever, headache, headache, fever | headache, fever, home early from work. |
| 31 | 2021-01-14 | dizziness, shortness of breath, fatigue, headache, malaise, somnolence, body temperature increased, chills |
1/12 0715: Received Pfizer covid-19 vaccine dose 2 at end of shift. Went home to sleep after waiting...
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1/12 0715: Received Pfizer covid-19 vaccine dose 2 at end of shift. Went home to sleep after waiting 15 min. 1630: Woke up. Felt more tired than usual. 1900: Arrived at work. Felt fatigue and sore arm. 2000: Felt sore arm, fatigue, and mild HA. Drank coffee and this helped with fatigue and HA. 2100: Mild nausea starts. Still have sore arm. Less fatigue, no HA. Still able to eat with the nausea. 2200: Developed chills. I was putting up curtains in an isolation room and had to pause halfway through due to being short of breath as if I'd done something strenuous. I then was short of breath again walking specimens to lab, which is unusual for me. Walking samples to lab involves walking 400 ft and going up and down 1 flight of stairs. 2300: Coworkers keep asking me why I'm always out of breath. They are concerned. Chills are worse now and I go from feeling normal to feeling cold. My hands are like ice and I am gripping my arms to keep warm. I walk 2 samples to lab and each time I am dizzy on the way back. By the 2nd time I have to hold the wall to keep balance. I can no longer hide the side effects and a coworker offers me 650mg Tylenol. I gladly accept. I measure my spO2 and it is 97%. 1/13 0530: I am almost back to normal other than feeling fatigued. 0815: I get home and go to bed. My feet are ice cold so I have to wear socks, but my hands feel normal temperature. I feel like my blanket isn't warm enough. 1330: I wake up and feel absolutely miserable. I am going between having chills to having a hot flash. I can't seem to will myself to leave bed. I'm pretty sure I have a fever, which I haven't had in over 10 years. My mouth is completely dry. 1400: I manage to roll out of bed and take my temperature, which is 101.3F. I feel an overall malaise and keep getting periodic hot flashes, but manage to make it downstairs and I mix 1 liquid IV electrolyte packet w/ 24fl oz. water. I drank the whole thing. I also cooked myself some dumplings and 1 waffle w/ maple syrup due to feeling much hungrier than usual. 1430: I take 1000mg Extra Strength Tylenol after eating. 1830: I feel almost normal except for significant fatigue and go to bed. 1/14 0430: I wake up and feel completely normal. No fatigue. Go about my day as normal. 1545: Suddenly I feel lightheadedness and mild HA. Have trouble with inattention (ex. not following w/ conversation or forgetting what people just said, or listening but not registering, or can't find the words to respond or answers to a question.). I take my Vitals: 117/95, spO2 85%, HR 63. I then try taking a couple deep breaths and spO2 increases to 98% and lightheadedness and HA go away. Then a few minutes later lightheadedness and HA begin again and spO2 is 80-90%. Then I take 2 deep breaths and spO2 is 98% and HA and dizziness improves. This repeats several times and I grow concerned. My hands are cold and the pulse oximeter is $30 from Amazon. However, I used the pulse ox on my mother and she was 97% consistently every time without fail. I also used pulse ox on myself when perfectly healthy and same thing it was 98%+ every time. This is why I was now worried. 1630: I take Tylenol since this seems to have helped with any and every symptom I've had so far and book an Urgent Care appointment. 1700: I get up to take a shower and feel extremely dizzy to the point where I'm worried I might fall. I stumble into the bathroom holding the wall. I take spO2 and it is 87%. 1800: I show up to Urgent Care and after the shower I feel my hands are warm now. At Urgent Care they are using pulse oximeters and I am spO2 99% and HR 64. So they chalk it up to my crappy Amazon pulse ox and they tell me to hang in there. Perhaps if I had not taken a shower before going there it may have been a different story? Hard to say now. Also the Tylenol may have started to work by then. 2200: I am still inattentive, spacey, lightheaded, and fatigued. I then fell asleep on the couch without realizing. 1/15 0230: I wake up and feel fatigued with brain fog, but no more lightheadedness. 0630: I go back to bed because I'm too sleepy.
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| 31 | 2021-01-14 | sweating, chills, headache, fever |
1/13 got vaccine at 12 noon-about 12 hours later ?Middle of the night woke up with sweats, fever, he...
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1/13 got vaccine at 12 noon-about 12 hours later ?Middle of the night woke up with sweats, fever, headache, nausea, body aches, chills, joint pain and rash on right arm. Symptoms continued all through the day and next night. Fever resolved 1/15 in the am with highest fever that day being 99, muscle aches still persisted and headache persisted through the day. This day the headache was the worst symptom and it was very severe. The new thing that started on this second day post vaccination was nausea and abdominal pain which was not present as badly the day after.
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| 31 | 2021-01-14 | fever, chills |
4 documented fevers. One fever a week for 4 weeks for approximately 2-3 hours each time. Temperature...
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4 documented fevers. One fever a week for 4 weeks for approximately 2-3 hours each time. Temperature max 102.3. went away without medication. Body aches and chills with fever but went away after fever was gone.
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| 31 | 2021-01-14 | fatigue, dizziness, fever |
After second vaccine dose on 1/8/2021, I felt fatigue and muscle aches on 1/9/21 in the afternoon. I...
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After second vaccine dose on 1/8/2021, I felt fatigue and muscle aches on 1/9/21 in the afternoon. I felt normal on Sunday and throughout the week. Then, 1-14-21 starting around 8am, I developed GI symptoms, stomach cramping, nausea, and also light-headed and muscle aches. I left work and at home developed a headache and fever of 100.8 F which reduced to 100.2 F with ibuprofen. The fever went away over night so I came to work the next day 1/15/21 and continue to have stomach cramping and slight nausea and was concerned about the fever the day before so that is when I called employee health.
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| 31 | 2021-01-14 | fever, nasal congestion, throat irritation, cough, chills |
Body aches, chills, feverish, fatigue, sneezing started on evening of 12/23. 12/24 - loss of taste, ...
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Body aches, chills, feverish, fatigue, sneezing started on evening of 12/23. 12/24 - loss of taste, body aches but improved, sneezing. 12/25-cough, severe nasal and sinus congestion, no smell or taste, sneezing. 12/26-congestion, no smell and improved taste, achy, scratchy throat. Sought medical advise on 12/26 primarily due to congestion and scratchy throat.
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| 31 | 2021-01-14 | chills, fever |
Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration o...
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Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; This is a spontaneous report from a contactable other health care professional (patient). A 31-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration (left arm) second dose on 07Jan2021 09:30 at single dose for covid-19 immunisation. The patient's medical history included known allergies: Sulfa drugs and known allergies: latex sensitivity. The patient's concomitant medication included spironolactone, bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), and multi vitamin. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), for covid-19 immunisation first dose on 17Dec2020, Vaccine location Left arm, lot number EH9899. On 07Jan2021 10:00 PM, the patient experienced Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours. The patient did not received treatment for the events. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not tested positive for covid post vaccination.
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| 31 | 2021-01-14 | headache |
Daily Headaches; This is a spontaneous report from a non-contactable nurse (patient). A 31-year-old ...
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Daily Headaches; This is a spontaneous report from a non-contactable nurse (patient). A 31-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date: unknown), via an unspecified route of administration, on left arm, on 20Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included allergy to bacteria. The patient is not pregnant. Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE]), colecalciferol (VIT D3), choline, ascorbic acid, pyrroloquinoline quinone, tocopherol (PQQ), and lavandula angustifolia extract, melissa officinalis extract, origanum vulgare extract (MELATON [LAVANDULA ANGUSTIFOLIA EXTRACT;MELISSA OFFICINALIS EXTRACT;ORIGANUM VULGARE EXTRACT]). The patient had no prior Covid vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Dec2020, the patient experienced daily headaches but did not receive any treatment. The patient underwent lab tests and procedures which included nasal swab PCR test on 30Dec2020 and on 08Jan2021, both showed negative. Outcome of the event daily headaches was unknown.
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| 31 | 2021-01-14 | nerve pain |
Developed a golf ball sized painful lymph node in my left axilla after getting the 2nd Pfizer vaccin...
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Developed a golf ball sized painful lymph node in my left axilla after getting the 2nd Pfizer vaccine in my left arm. Associated with shooting sharp nerve pain radiating down the left arm in the medial nerve distribution, likely from nerve impingement. I am self treating with advil since I am a physician and giving it time to resolve
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| 31 | 2021-01-14 | fatigue, chills |
Diarrhea/severe cramps overnight the next day (6-7 loose stools), treated with one dose of Imodium w...
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Diarrhea/severe cramps overnight the next day (6-7 loose stools), treated with one dose of Imodium with some improvement. Resolved after 12hours. Severe fatigue and chills lasting 24hrs and resolved without any treatment.
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| 31 | 2021-01-14 | fatigue, chills, sweating, migraine |
Fatigue; Body aches; Migraine; Vomiting; Chills; Sweats; This is a spontaneous report from a contact...
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Fatigue; Body aches; Migraine; Vomiting; Chills; Sweats; This is a spontaneous report from a contactable other health professional (patient). A 31-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on 07Jan2021 09:15 at a single dose on Left arm for COVID-19 immunization. Medical history included Chronic back pain, and latex allergy. Concomitant medication included gabapentin, acetaminophen, tramadol, sulindac, methocarbamol. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 17Dec2020 09:30 at a single dose on right arm for COVID-19 immunization. The patient experienced fatigue, body aches, migraine, vomiting, chills, sweats on 07Jan2021 12:30. No treatment received for adverse event. The outcome of the event was recovered on an unspecified date in Jan2021. The events were assessed as non-serious. The patient was not pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 31 | 2021-01-14 | fever, chills, fatigue |
Fever on the following day (January 12, 2021) after the second dose that began around 5:00 AM. Sympt...
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Fever on the following day (January 12, 2021) after the second dose that began around 5:00 AM. Symptoms included: fatigue, chills, fever, lack of appetite. The fever was not present on January 13, 2021.
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| 31 | 2021-01-14 | fever, head discomfort, headache, fatigue |
Head felt heavy/full/tingly starting about 6 pm on day of vaccination, fell asleep around 9:30 pm an...
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Head felt heavy/full/tingly starting about 6 pm on day of vaccination, fell asleep around 9:30 pm and woke up about 11 pm with left arm pain, very fatigued. Went back to sleep and woke up around 4 am with fever up to 100.6F, headache, muscle aches, joint pain, and extreme fatigue. My left axilla was swollen with arm pain to mid left chest and back, and my axillary lymph node was painful and swollen to about the size of a large grape. I took 440 mg of Aleve around 8:30 when the fever did not subside. The fever broke and did not return. I slept most of the day and was unable to work. My left axillary lymph node is still palpable as of today, 1/15.
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| 31 | 2021-01-14 | fever, chills, headache, fatigue |
Injection site pain appeared right after vaccine administration. Pain became more severe the next da...
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Injection site pain appeared right after vaccine administration. Pain became more severe the next day and it lasted for a total of three days(1/8~1/10) The next day of vaccination(1/9), I have symptoms of low grade fever, chills, fatigue, mild body aches, headache, vomiting feeling. However, these symptoms only lasted for one day.
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| 31 | 2021-01-14 | fever, chills | Low fever for two days, strong muscle aches, chills. Took ibuprofen OTC and helped. |
| 31 | 2021-01-14 | cough, throat irritation |
Patient did not report an adverse reaction following dose #1. Within minutes of receiving vaccine d...
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Patient did not report an adverse reaction following dose #1. Within minutes of receiving vaccine dose #2, patient c/o flushing. VS 131/88, 100% RA, Hr 102, temp 97.5, RR 20, no SOB nor difficulty breathing. About 10 minutes post dose, patient reported feeling anxious, BP 130/87, HR 107, RR 20. Some swelling of lip on inner side. About 20 minutes post dose, patient started coughing and c/o itchy throat. Transported to ED where patient received epinephrine, Benadryl, solu-medrol, famotidine, NS 500mL bolus. Symptoms resolved and after 3.5 hours observation was discharged. After the patient was transported to the ED, a jar of nuts was found in the vicinity of where the patient was sitting post-vaccination.
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| 31 | 2021-01-14 | chills, dizziness, fatigue, headache |
Pfizer-BioNTech COVID-19 Vaccine EUA Chills/temp 38 (starting 2200 1/10-1/12) Moderate nausea (1/10...
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Pfizer-BioNTech COVID-19 Vaccine EUA Chills/temp 38 (starting 2200 1/10-1/12) Moderate nausea (1/10-still present as of 1/15) Mild-mod headache (1/11-1/13) Tachycardia (at rest 105-138 1/10-1/13) Moderate muscle/joint pain - same side as injection from shoulder/collar bone into neck (1/11-still present as of 1/15) Moderate-severe fatigue (1/10-1/14) Dizziness (1/12-1/14) Used ibuprofen and Bengay for soreness w/ mild/fair effect.
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| 31 | 2021-01-14 | dizziness, throat irritation, chills |
Sensation of heat and numbness tingling in Chest up into throat mouth and lips, palpitations, dizzin...
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Sensation of heat and numbness tingling in Chest up into throat mouth and lips, palpitations, dizziness, elevated heart rate, chills, tingling in extremeties, burning in throat ; started aprroximately two minutes after administration, took benedryl and water, waited another 15 minutes where signs and symptoms started to subside a little bit and thought I was okay but then came back at about 25 minutes post vaccine where it was decided to go to emergency department.
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| 31 | 2021-01-15 | weakness, fever, malaise, headache, chills |
1/14 Around 5pm general malaise, headache, chills 1/15 Around 4am worsening headache, body aches, f...
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1/14 Around 5pm general malaise, headache, chills 1/15 Around 4am worsening headache, body aches, fever 101.7 Spent all day in bed no energy to get up or do anything 1/16 no fever, general malaise, headache. Got covid test pending results
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| 31 | 2021-01-15 | chills, fever | Chills/fever, body aches |
| 31 | 2021-01-15 | shortness of breath, malaise, influenza like illness, fatigue |
flu like symptoms, shortness of breath, chest pain with deep inspiration, fatigue, malaise, body ach...
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flu like symptoms, shortness of breath, chest pain with deep inspiration, fatigue, malaise, body aches
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| 31 | 2021-01-16 | fatigue, fever, headache |
11 hours after injection: fever (100.4), headache, joint pain. 22 hours after injection: fever (103...
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11 hours after injection: fever (100.4), headache, joint pain. 22 hours after injection: fever (103.4), severe headache, joint paint, fatigue, body aches Treated with Tylenol and ibuprofen
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| 31 | 2021-01-16 | fatigue |
1st day: fatigue, intermittent joint pain/urticaria. 2nd day: generalized rash, pruritus - have take...
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1st day: fatigue, intermittent joint pain/urticaria. 2nd day: generalized rash, pruritus - have taken benadryl
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| 31 | 2021-01-16 | headache | Itchy skin Nausea Bad Headache Severe L arm pain |
| 31 | 2021-01-16 | headache, fatigue, shortness of breath | generalized body aches, shortness of breath, extreme fatigue, headache |
| 31 | 2021-01-17 | fever | Soreness in left arm persisting for 3 days, fever |
| 31 | 2021-01-17 | chills |
following day around 7pm lip swelling; tongue tingling; body hives; chills; After first dose of Covi...
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following day around 7pm lip swelling; tongue tingling; body hives; chills; After first dose of Covid vaccine face flushing; increased HR about 45 mins. went away on its own; hours later left eye swollen; This is a spontaneous report from a contactable Nurse (patient). A 31-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot number: EK9231), via an unspecified route of administration on 06Jan2021 15:00 at single dose on Left arm for covid-19 immunisation. Medical history included Known allergies: Shellfish, IV contrast dye, Penicillin. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced after first dose of covid vaccine face flushing; increased hr about 45 mins. went away on its own since 06Jan2021 16:00; hours later left eye swollen on 06Jan2021; following day around 7pm lip swelling, tongue tingling, body hives, chills on 07Jan2021 19:00. The patient underwent lab tests and procedures which included heart rate: increased on Jan2021. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Ae treatment: Steroids, IV fluids, Benadryl. No COVID prior vaccination. No COVID tested post vaccinate. This report was reported non-serious. The event outcome of increased hr about 45 mins. went away on its own was recovered on 06Jan2021 16:45, outcome of other events were not recovered.; Sender's Comments: Based on the compatible time association, the serious events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 31 | 2021-01-18 | chills |
Chills, Bodyaches, Nausea & Back Discomfort developed 12 hours after receiving vaccine - resolved af...
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Chills, Bodyaches, Nausea & Back Discomfort developed 12 hours after receiving vaccine - resolved after 48hrs.
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| 31 | 2021-01-19 | fatigue, fever |
2nd day after the vaccination, my left arm had a swollen bump below the injection site along with pa...
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2nd day after the vaccination, my left arm had a swollen bump below the injection site along with pain. I felt fatgued, slight fever, and body aches. I took an antihistamine for 5 days and the symptoms resolved itself.
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| 31 | 2021-01-19 | fever |
6 DAYS OF SINTOMES ,PAIN INJECTION SITE,MUSCULAR PAIN, FEVER SWELLING ON SHOULDER AREA,LIMITED OF MO...
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6 DAYS OF SINTOMES ,PAIN INJECTION SITE,MUSCULAR PAIN, FEVER SWELLING ON SHOULDER AREA,LIMITED OF MOVEMENT ,LAST 3 DAYS SINTOMES MILD.
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| 31 | 2021-01-19 | fever |
6 DAYS OF SINTOMES MUSCULAR PAIN,FEVER , SWELLING ON SHOULDER,LIMITED IN MOVIEMENT ON THE ARM AFTER...
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6 DAYS OF SINTOMES MUSCULAR PAIN,FEVER , SWELLING ON SHOULDER,LIMITED IN MOVIEMENT ON THE ARM AFTER THE FOUTH DAY SINTOMES ARE MILD, SWELLING WENT DOWN.
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| 31 | 2021-01-19 | shortness of breath |
Approximately 10 to 15 minutes post injection she started feeling hot, then patient began to become ...
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Approximately 10 to 15 minutes post injection she started feeling hot, then patient began to become flushed . I gave her oral benadryl 50 mg and 40 mg of famotidine oral. The difficulty in breathing did not lessen. She began to use her accessory muscles. Her O2 sats were 99% via finger pulse oximeter. Breathing became increasingly labored. An Epi pen 0.3 mg was administered. An ambulance was called. Her breathing became less labored, she was transported to the hospital via ambulance to be checked out.
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| 31 | 2021-01-19 | nasal congestion, throat irritation |
Approximately 8 hours after receiving the vaccine she began noticing itchy throat, eyes, ears, nasal...
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Approximately 8 hours after receiving the vaccine she began noticing itchy throat, eyes, ears, nasal congestion and sneezing. These symptoms lasted for about 48 hours.
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| 31 | 2021-01-19 | headache |
BODY ACHES, HEADACHE, COLD. PRESSURE ON LEFT ARM AND PRESSURE ON LEFT CHEST. UTILIZED HEATING PADS F...
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BODY ACHES, HEADACHE, COLD. PRESSURE ON LEFT ARM AND PRESSURE ON LEFT CHEST. UTILIZED HEATING PADS FOR ARM AND CHEST.
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| 31 | 2021-01-19 | malaise, fever, fatigue |
Employee received her 2nd Pfizer vaccine on 1/12/2021. Twelve hours after her vaccine she develope...
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Employee received her 2nd Pfizer vaccine on 1/12/2021. Twelve hours after her vaccine she developed a fever with a T-max of 102 degrees. The fever lasted 18 hours. She also complained of severe malaise and fatigue lasting 36 hours. On day 3 (Friday, January 15, 2021) she developed left lower extremity pain that persisted over the weekend. She was seen in Urgent Care today where she was diagnosed with a deep vein thrombosis of the proximal vein. She also came to the ETC and was ruled out for a PE. The employee does have a family history of antiphospholipid in her mother. She has a follow up with her PCP and will also receive a work up in hematology as she had never been tested for any genetic coagulation conditions after her mom's diagnosis.
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| 31 | 2021-01-19 | fatigue, fever, malaise |
Employee received her 2nd Pfizer vaccine on 1/12/2021. Twelve hours later she developed a fever wit...
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Employee received her 2nd Pfizer vaccine on 1/12/2021. Twelve hours later she developed a fever with a T-max of 102 degrees. The fever lasted 18 hours. She also complained of severe malaise and fatigue lasting 36 hours. On day 3 she developed left lower extremity pain that persisted over the weekend. She was seen in Urgent Care today where she was diagnosed with a thrombosis. She also came to the ETC and was ruled out for a PE The employee does have a family history of antiphospholipid in her mother. She has a follow up with her PCP and will also receive a work up in hematology as she had never been tested for any genetic coagulation conditions after her mom's diagnosis.
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| 31 | 2021-01-19 | chills, migraine, malaise, sweating, headache, fatigue |
Estimated due date: 07/16/2021 About 5 hours after the vaccine my arm started to hurt and I started...
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Estimated due date: 07/16/2021 About 5 hours after the vaccine my arm started to hurt and I started having all body aches and chills, never had a fever. Very fatigued. At night I threw up and about 2AM I woke up drenched in sweat and I did not take my temperature. I woke up around 7AM and I had a migraine for about 2/3 hours - pounding headache. I took Tylenol, My body was really achy and my arm was like it was dead. General malaise, fatigue, it felt like I had a hangover, from my pounding headache. I threw up once again in the afternoon. Not sure if pregnancy related or the vaccine. Sunday morning I started feeling a little better. Saturday I felt horrible.
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| 31 | 2021-01-19 | chills, malaise, fatigue, fever |
Fever (max 102 degrees Fahrenheit) after 12 hours of the vaccine, lasting for approximately 18 hours...
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Fever (max 102 degrees Fahrenheit) after 12 hours of the vaccine, lasting for approximately 18 hours total. Accompanied by chills, malaise, myalgias. Continues with mild tiredness and shortness of breath on exertion over the next few days. COVID-19 test done on 1/13/2021 due to severity of symptoms, was negative. 3 days later (1/15/2021) left calf pain with mild edema, subsequently diagnosed (1/20/2021) as a left posterior tibialis complete vein occlusion (DVT). Chest CT done to rule out pulmonary emboli. Anticoagulation prescribed (xarelto).
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| 31 | 2021-01-19 | fever, headache, fatigue, chills |
Fever, chills, fatigue, muscle aches, nausea, headache all day on 1/19/20. Called the virtual hub t...
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Fever, chills, fatigue, muscle aches, nausea, headache all day on 1/19/20. Called the virtual hub to report symptoms and I am scheduled for a covid test today at 1 to be safe.
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| 31 | 2021-01-19 | headache, fever |
HR maintaining 120+ at rest; Fever 103.5; extreme body aches; headaches; 8/10 pain in L axillary and...
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HR maintaining 120+ at rest; Fever 103.5; extreme body aches; headaches; 8/10 pain in L axillary and chest area; 8/10 pain in L axillary and chest area; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscularly on the left arm, first dose on 17Dec2020 07:15 and second dose on 08Jan2021 07:15, both at a single dose for COVID-19 immunization. There were no medical history nor concomitant medications (within two weeks of vaccination). The patient was not diagnosed with/did not have COVID-19 prior to vaccination, did not receive other vaccines in four weeks prior to vaccination, had no known allergies to medications, food, or other products, and was not pregnant. The most recent COVID-19 vaccine was administered at a hospital facility. On 07Jan2021 18:00, the patient experienced fever 103.5, extreme body aches, headaches 8/10 pain in left axillary and chest area, and HR maintaining 120+ at rest. The patient underwent lab tests and procedures which included COVID test post vaccination with a curative oral swab: negative on 08Jan2021. No treatment was received for the adverse events. Outcome of the events was recovering. The events were reported as non-serious.
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| 31 | 2021-01-19 | migraine, fever, chills |
High fever 101.9 began the evening when I got my shot and as of an hour ago just came under the 100 ...
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High fever 101.9 began the evening when I got my shot and as of an hour ago just came under the 100 mark. I?ve been taking Tylenol every 4-6 hours to combat high fever but it wasn?t going down. I had chills with the fever, so bad that my body was shaking. Fever stayed in the 101 range from Monday evening until Wednesday morning. Extreme shoulder pain radiating from left to right on Monday evening - lasted into the early morning on Tuesday. Chest tightness with R shoulder pain Tuesday afternoon from roughly 130p-315p. It subsided and so I did not seek medical attention. I?ve also had a severe migraine the entire time since getting my shot, but haven?t taken my Ubrelvy as I wasn?t sure how my body would react.
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| 31 | 2021-01-19 | headache, fatigue, fever | I have a subjective fever, and fatigue and severe headache and body pain |
| 31 | 2021-01-19 | weakness, fever, headache |
Jan 4, 2021 received shot at work in morning around 11:00 am- felt fine at work all day. Around 7:00...
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Jan 4, 2021 received shot at work in morning around 11:00 am- felt fine at work all day. Around 7:00 that night began to have back pain, fever reached up to 102 around 2:00 am and took Tylenol. Felt very weak, headache, difficulty walking and decreased balance. On Jan 5, 2021 still had back ache and headache. On Jan 6, 2021 I felt better and began to have abdominal pain after eating dinner. I assumed it may be because of eating more then I had in past few days and did not attribute to much but the pain gradually increased to a strange burning/pressure across my upper abdomen that night. Very nauseous and ran low grade fever (99.45). Next morning I had less diffuse pain and could localize it to right lower quadrant.
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| 31 | 2021-01-19 | headache, fatigue | Localized, painful injection site reaction Fatigue Headache |
| 31 | 2021-01-19 | headache, fatigue |
Myalgias; cephalgia; nausea; diarrhea; abdominal pain; Fatigue; first dose on 15Dec2020 15:30, secon...
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Myalgias; cephalgia; nausea; diarrhea; abdominal pain; Fatigue; first dose on 15Dec2020 15:30, second dose on 04Jan2021 16:00; first dose on 15Dec2020 15:30, second dose on 04Jan2021 16:00; This is a spontaneous report from a contactable physician (patient). A 31-year-old non-pregnant female patient receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1284), via an unspecified route of administration on 04Jan2021 16:00 at single dose (Vaccine location: Left arm) for COVID-19 immunization. Medical history included Anxiety and Allergic Rhinitis. There were no known drug allergies. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) via an unspecified route of administration (Vaccine location: Left arm) on 15Dec2020 15:30 at single dose for COVID-19 immunization. There were no other vaccines received in four weeks. Concomitant medication included fexofenadine, sertraline. The patient did not have Covid-19 prior vaccination and did not have Covid-19 tested post vaccination. The patient experienced Myalgias, cephalgia, nausea, diarrhea, abdominal pain, fatigue on 05Jan2021 08:00. No treatment received for the reported events Myalgias, cephalgia, nausea, diarrhea, abdominal pain, fatigue. The outcome of the events Myalgias, cephalgia, nausea, diarrhea, abdominal pain, fatigue was recovered in Jan2021.
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| 31 | 2021-01-19 | headache, chills, fever | fever, chills, headache, body aches |
| 31 | 2021-01-21 | headache, dizziness | Extreme dizziness and headache |
| 31 | 2021-01-21 | fatigue, throat pain |
Mild-to moderate sore throat; started about 24 hours after the vaccine and lasted for about 24 hours...
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Mild-to moderate sore throat; started about 24 hours after the vaccine and lasted for about 24 hours. I didn't have to take any medication for it and didn't have to call out work. Was a lot more more fatigued that day of the sore throat. Pregnancy- Sept 6, 2021; normal; low risk pregnancy
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| 31 | 2021-01-21 | weakness | Systemic: numbness in arms, legs, weakness -Severe |
| 31 | 2021-01-21 | headache | severe muscle aches, joint pain, headache |
| 31 | 2021-01-22 | dizziness |
After I had the 2nd dose of the Pfizer, my left arm was numb and couldn?t drive but I was able to li...
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After I had the 2nd dose of the Pfizer, my left arm was numb and couldn?t drive but I was able to live with it until the 4th day, during working period I suddenly felt dizzy and nauseous, went to throw up, dizziness was intense then I fell off my chair and was rushed to the Emergency for treatment, was treated for vertigo and given Meclizine to reduce the dizziness and nausea. Till date the dizziness wouldn?t go away.
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| 31 | 2021-01-24 | fever, fatigue, chills |
101 fever (w/tylenol), chills, body aches, fatigue, chest tightness and chest pain(only for 1 hour)-...
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101 fever (w/tylenol), chills, body aches, fatigue, chest tightness and chest pain(only for 1 hour)--all resolved in 48 hours
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| 31 | 2021-01-24 | headache |
Headache; myalgia; nausea; diarrhea; second dose received on 14Jan2021; This is a spontaneous report...
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Headache; myalgia; nausea; diarrhea; second dose received on 14Jan2021; This is a spontaneous report from a contactable Physician. A 31-year-old female Physician (patient) reported that received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the left arm on 13Jan2021 at 01:15 PM for COVID-19 immunization. The patient had received the first dose on 13Dec2020 at 01:15 PM Intramuscular in Left arm. Medical history included migraines. On 14Jan2021 at 12:00 PM, the patient experienced headache, myalgia, nausea and diarrhea. The patient was not Covid tested post vaccination. At the time of reporting the patient was recovering Information about batch/lot number has been requested.
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| 31 | 2021-01-24 | dizziness |
While being observed in waiting area, patient reported that she felt as if she was going to pass out...
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While being observed in waiting area, patient reported that she felt as if she was going to pass out. Patient was then lowered to the ground by 2 medics as patient briefly passed out. Patient was taken to medic area where she informed that she often has syncopal episodes.
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| 31 | 2021-01-24 | dizziness |
While being observed in waiting area, patient reported that she felt as if she was going to pass out...
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While being observed in waiting area, patient reported that she felt as if she was going to pass out. Patient was then lowered to the ground by 2 medics in which patient briefly passed out. Patient was taken to medic area where she informed that she ofter has syncopal episodes.
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| 31 | 2021-01-25 | headache, fatigue, chills, fever |
103 degree Fahrenheit fever; chills; nausea; fatigue; headache; This is a spontaneous report from a ...
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103 degree Fahrenheit fever; chills; nausea; fatigue; headache; This is a spontaneous report from a contactable nurse (patient). This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 08:15 at single dose at left arm for COVID-19 immunization. The patient's medical history included hypertension. No known allergies. The patient's concomitant medications included ergocalciferol (VIT D), ascorbic acid (VIT C) and Beta blocker. No other vaccine received in four weeks. Patient was not pregnant. Facility type vaccine was hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient received second dose on 07Jan2021 19:45 at left arm for COVID-19 immunization. The patient experienced 103 degree Fahrenheit fever, chills, nausea, fatigue, headache for 48 hours on 07Jan2021 19:30. No treatment received. Outcome of the events was recovered. Information about Lot/Batch has been requested.
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| 31 | 2021-01-25 | throat swelling, fatigue, throat pain, fever |
Injection site immediately felt severe itchy following injection but diminished after approx. 30-45 ...
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Injection site immediately felt severe itchy following injection but diminished after approx. 30-45 minutes. I then felt fine until exactly 3:00 pm (approx. 3 hours following injection). I stood up and immediately felt like passing out. I had excruciating cramping throughout my legs and horrible joint pain in my knees. By 3:30 I had hives covering my right hand- my hand was also very red and swollen and had severe itching/burning. By now I also had horrific joint and muscle pains all over my entire body and the leg cramping was even worse. the hives responded well two doses of Benadryl and the muscle aches somewhat improved with rotation of ibuprofen and Tylenol. By 5:00 am the following day, the joint and muscle pains were worse. My entire body felt like it was on fire and I had excruciating pain in my throat. It was difficult to speak or swallow and I could feel my throat swollen on the inside. My neck was also slightly swollen and the lymph nodes on the left side of my neck were in horrific pain but not swollen. I continued doses of Benadryl, ibuprofen and Tylenol all day and night and slept most of the time. By Sunday Morning, my throat felt even worse and I had 100 degree fever and continued body aches and joint pain. I was seen at a local urgent care who ran various tests (see below) that were negative and advised me to treat as if it were an allergic reaction and go to ER if I got any worse. Fever and pain improved by Monday and by Tuesday I was able to return to work but with significant fatigue and continued pain in my legs. I continued to improve throughout the week. Now the following week I overall feel back to normal other than I have continued leg pain, esp. in my knees by the end of the day.
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| 31 | 2021-01-25 | body temperature increased, headache, chills | Temp 101, then 100, joint pain, headaches and chills |
| 31 | 2021-01-26 | headache, malaise, fever, chills |
Chills; fever with a temperature max of 103 Fahrenheit; Headache; Malaise; This is a spontaneous rep...
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Chills; fever with a temperature max of 103 Fahrenheit; Headache; Malaise; This is a spontaneous report from a non-contactable physician (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration (left arm) on 04Jan2021 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 16Dec2020 for Covid-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient experienced chills followed by fever with a temperature max of 103 Fahrenheit for 1 day, headache, and malaise on 04Jan2021 (20:00). The patient was treated with Motrin. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
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| 31 | 2021-01-26 | chills |
EST. date of my delivery is 5/11/2021 30 hours after the dose had adnominal pain. Several episode...
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EST. date of my delivery is 5/11/2021 30 hours after the dose had adnominal pain. Several episode of diarrhea. Also had nausea and chills.
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| 31 | 2021-01-26 | cough, chills, fever, fatigue | Fever, chills, fatigue, cough, body aches |
| 31 | 2021-01-26 | fever, headache |
Mild headache; mild low back pain; fever/Peak temp was 101.4F; This is a spontaneous report from a c...
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Mild headache; mild low back pain; fever/Peak temp was 101.4F; This is a spontaneous report from a contactable physician (patient). A 31-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the left arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a workplace clinic facility. Medical history included known allergies to egg whites and yogurt. The patient has no covid prior vaccination. Concomitant medications included vitamin d3 and cyanocobalamin (VITAMIN B12). The patient has no other vaccine in four weeks. On 24Dec2020, the patient experienced mild headache, mild low back pain, and fever which started 20-24 hours after vaccine was given. Peak temp was 101.4F about 32 hours after vaccine was given (24Dec2020 20:00). The patient did not take any medication for it (no acetaminophen, no NSAIDs). Temperature was 98.9F at 44 hours after vaccine (25Dec2020 08:00). All symptoms resolved on their own within 48 hours (26Dec2020). The covid test post vaccination showed that patient had negative covid test result based on nasal swab on 26Dec2020. Information about the lot/batch number and expiry date were unknown.
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| 31 | 2021-01-26 | fatigue, fever, headache | Nausea, Vomiting, Diarrhea, fatigue, muscle soreness, body aches, headache, small fever |
| 31 | 2021-01-26 | fever, throat pain |
Patient received initial COVID-19 vaccine on 1/16/2021. Experienced injection site soreness and a l...
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Patient received initial COVID-19 vaccine on 1/16/2021. Experienced injection site soreness and a little fever lasting 48 hours. On 1/19/2021, patient developed severe sore throat/odynophagia. Went to an urgent care, and strep throat screen and COVID test and both resulted negative. Odynophagia continued, painful to swallow food/liquids. Never developed tongue or lip swelling. Due to ongoing fevers, patient admitted to hospital for ulcerative pharyngitis
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| 31 | 2021-01-26 | shortness of breath, chills, fatigue |
Severe rigors involving core and extremities, making it difficult to breathe.; Severe rigors involvi...
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Severe rigors involving core and extremities, making it difficult to breathe.; Severe rigors involving core and extremities, making it difficult to breathe.; muscle pain; joint pain noted in hips; loss of appetite; profound fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), via an unspecified route of administration on 11Jan2021 11:45 on the left arm at a single dose for COVID-19 immunization. The patient received the vaccine in a hospital. The patient had no other vaccine in four weeks. Medical history included clinical depression. The patient has no known allergies. The patient was not tested for COVID prior and post vaccination. Concomitant medications included bupropion and multivitamin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK5730, expiry: unknown) on 21Dec2020 at 11:00 in the right arm for COVID-19 immunization. On 12Jan2021 at 01:00, the patient experienced severe rigors involving core and extremities, making it difficult to breathe. Flexeril 10 mg was taken to help relieve rigors. Rigors stopped and ease of breathing resumed in 1 hour. Other symptoms include muscle pain, joint pain noted in hips, loss of appetite, and profound fatigue x48 hrs. The events difficult breathing, muscle pain, joint pain noted in hips, loss of appetite and profound fatigue were not treated. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of "severe rigors involving core and extremities, making it difficult to breathe". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 31 | 2021-01-26 | throat swelling |
Within thirty minutes of administration I started feeling itchy around injection site then all over ...
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Within thirty minutes of administration I started feeling itchy around injection site then all over my entire body. I stated to have some facial swelling then my throat started to swell/tighten. I was brought to the ED and an IV was started. They administered IV fluids, Benadryl, Prednisone, and Pepcid. The throat swelling started to interfere with my speaking and vocals. They monitored me for 7 hours then I was discharged home. All symptoms returned within a few hours and persisted for a week following. My PCP took over care and prescribed me the following in replace of the medications the ER prescribed: Albuterol HFA, Dexamethasome, Pepcid, Benadryl, Z-Pak, Vitamin D 100,000iu, and Fish Oil. I missed a week of week then was released to work again on 1/25/21.
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| 31 | 2021-01-26 | chills, dizziness |
one syncopal episode; Shaking chills; light headed; pregnant female patient received the vaccine; pr...
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one syncopal episode; Shaking chills; light headed; pregnant female patient received the vaccine; pregnant female patient received the vaccine; pregnant female patient received the vaccine; This is a spontaneous report from a contactable healthcare professional (patient). This healthcare professional only reported information for the mother (herself). This is the maternal case. A 31-year-old pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm, on 11Jan2021 at 08:15 (at the age of 31-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient's last menstrual period was 05Dec2020 and the patient was pregnant at the time of vaccination (5 gestation weeks) with a due date of 11Sep2021. Concomitant medications, taken within two weeks of vaccination, included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1685) on 21Dec2020 at 09:00 (at the age of 31-years-old) for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced shaking chills, light headed, and one syncopal episode on 12Jan2021 at 01:00. The pregnant female patient received the vaccine on 11Jan2021 at 08:15. The patient did not receive any treatment for the events. The clinical outcome of shaking chills, light headed, and one syncopal episode was recovered in Jan2021 and of pregnant female patient received the vaccine was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the close temporal relationship, the association between the event syncopal episode with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 31 | 2021-01-27 | shortness of breath |
After vaccination, patient complaining of chest pain / pressure, and sense of impending doom.Medicat...
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After vaccination, patient complaining of chest pain / pressure, and sense of impending doom.Medication administered per EMS EPI given x2 at 0956 and 1015 ASA 325 chewable given at 1004 for c/o crushing chest pain. Emergency response provider arrived present. Pt started with c/o epigastric and then crushing CP. Pt appeared to be unresponsive at 1020 but the several minutes later she is arousable and anxious, breathing labored and she is stating she is "going to die". Transported to ED where delirium was noted and due to elevated ammonia level current presumptive diagnosis is hepatic encephalopathy.
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| 31 | 2021-01-27 | migraine |
Sore arm, stinging pain in left arm on day following injecting. Lasted 24 hrs. Migraine started day...
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Sore arm, stinging pain in left arm on day following injecting. Lasted 24 hrs. Migraine started day after injection, lasted 7 days with mild to moderate relief through use of Advil, Tylenol, fioricet (prescribed by neurologist for migraine). Required Rx of decadrone from neurologist to break migraine cycle
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| 31 | 2021-01-27 | fever, headache, chills |
fever to 100; chills; myalgias; headache; axillary lymphadenopathy with swelling and pain; This is a...
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fever to 100; chills; myalgias; headache; axillary lymphadenopathy with swelling and pain; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140 expiration date unknown), via an unspecified route of administration in the left arm on 11Jan2021 at 10:45 at a single dose for COVID-19 immunisation. Medical history included non-celiac gluten induced enteropathy, COVID from 27Sep2020 to an unknown date (had COVID with mild course x2 days), and allergies to NSAIDS and SSRIs. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), amlodipine besilate (NORVASC), colecalciferol (VITAMIN D [COLECALCIFEROL]), and omeprazole (PRILOSEC [OMEPRAZOLE]) on unspecified dates for unspecified indications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899 expiration date unknown) on 22Dec2020 at 10:45AM in the left arm for COVID-19 immunization; also previously took amoxicillin and experienced allergies. The patient was not pregnant. On 12Jan2021, at 12:00 AM, 12 hours after vaccine, the patient experienced fever to 100, chills, myalgias, headache. The patient was better 12 hours later after one dose of Tylenol. The patient also had axillary lymphadenopathy with swelling and pain, present since day 1 post vaccine (12Jan2021) and still swollen but pain improving. There was no treatment received for the adverse events. The outcome of the events was recovering at the time of report.
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| 31 | 2021-01-28 | fatigue, chills |
4pm- tiredness 7pm-tiredness,nausea and chills 11pm- stomach cramping, tiredness, nausea, chills 1/...
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4pm- tiredness 7pm-tiredness,nausea and chills 11pm- stomach cramping, tiredness, nausea, chills 1/29 @1am- nausea, vomiting, severe chills, shaking, body aches, tiredness. 1/29- bodyaches continue through day.
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| 31 | 2021-01-28 | fever, headache | HEADACHE, NECK PAIN, RIGHT SIDED FACE PAIN, BODY ACHES, FEVER |
| 31 | 2021-01-28 | cough, shortness of breath, dizziness |
Went into anaphylactic shock. Started feeling dizzy and light headed 15 mins after the vaccine was ...
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Went into anaphylactic shock. Started feeling dizzy and light headed 15 mins after the vaccine was given. At 20 mins my throat felt tighter and it was making me cough trying to get air so they gave me 50 ml of benedryl into my right arm. I started to pass out and my breathing was labored so I was given my epipen and taken to the ER. While I was there I was monitored for 4 hours and given 2 more medications. One was a steroid, I?m unsure on the second.
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| 31 | 2021-01-28 | chills, migraine |
migraine, soreness in arm, unable to lift arm or turn head, whole body aches, extreme chills, slight...
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migraine, soreness in arm, unable to lift arm or turn head, whole body aches, extreme chills, slight nausea
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| 31 | 2021-01-30 | fatigue |
The next day of vaccination on 1/10/2021 I started feeling fatigue & astragalus. It lasted for about...
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The next day of vaccination on 1/10/2021 I started feeling fatigue & astragalus. It lasted for about 6hrs.
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| 31 | 2021-01-31 | headache, fever, chills |
About 14 hours after receiving the vaccine, I developed chills and felt feverish (do not own a ther...
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About 14 hours after receiving the vaccine, I developed chills and felt feverish (do not own a thermometer so was unable to check temp). Throughout the night, I had chills and moderate muscle/joint pain. The following day, I had chills, muscle aches, joint pain, and a headache. I took some Tylenol and the symptoms lessened significantly. The following day (48 hrs after receiving the vaccine), I felt completely back to normal.
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| 31 | 2021-01-31 | headache |
About 24 hours after receiving the vaccine, I developed a headache at the base of my skull and some ...
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About 24 hours after receiving the vaccine, I developed a headache at the base of my skull and some mild joint pain in my left hand. The joint pain lasted <1 day, the headache lasted ~1.5 days.
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| 31 | 2021-01-31 | headache |
tested positive for COVID-19; tested positive for COVID-19; headache; This is a spontaneous report f...
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tested positive for COVID-19; tested positive for COVID-19; headache; This is a spontaneous report from a contactable nurse (patient herself). A 31-year-old female patient (not pregnant) received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid vaccine, lot EL1283), via an unspecified route of administration in the right arm on 21Dec2020 at SINGLE DOSE, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccines in four weeks. She had a sars-cov-2 test via nasal swab on 30Dec2020 and was negative. She was re-tested for sars-cov-2 and she was positive (via nasal swab) on 04Jan2021. The patient had her second dose of bnt162b2 on 15Jan2021. She informed that she had headache that started 30Dec2020 and during the 10 days following the positive test. She received the vaccine in a hospital and had doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of events was recovered.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 21Dec2020, and a repeated sars-cov-2 test via nasal swab positive on 04Jan2021. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.
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| 31 | 2021-02-01 | influenza like illness, weakness |
numbness has moved up her neck; she touches her neck, it hurts a little; maintains numbness and "no ...
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numbness has moved up her neck; she touches her neck, it hurts a little; maintains numbness and "no control of her arm"/can barely move her right arm; paralyzed at the shoulder from the elbow up;it's numb; can barely move her right arm; paralyzed at the shoulder from the elbow up; flu like symptoms; Threw up a couple times; mild pain at the injection site; This is a spontaneous report from a contactable nurse reporting for herself. A 31-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EL3247, Expiry date 31May2021, via an unspecified route of administration in right arm on 16Jan2021 at 07:30 at single dose for COVID-19 immunization as frontline worker. The patient had no relevant medical history. There were no concomitant medications. The patient received BNT162B2 Pfizer-BioNTech COVID-19 Vaccine in Hospital. The patient reported that she was fine all day Saturday (16Jan2021), she just had some very mild pain at the injection site started a couple hours after getting injection. She developed flu like symptoms on the following day (17Jan2021) at 18:00PM and threw up a couple times. On 18Jan2021 at noon she noticed that she could barely move her arm: anything above her elbow on her right arm was not moving; it was paralyzed at the shoulder from the elbow up. If someone were to pick it up and let go, she couldn't control it at all. She also stated that she had no pain at all in that arm; she couldn't feel anything at all; it was numb. When she woke up on 19Jan2021 the numbness had moved up her neck, instead of being localized to her arm. She stated that when she touched her neck, it hurt a little, but it was not super significant. She stated that it was debilitating at that point as she was maintaining numbness and "no control of her arm". The nurse reported that this event had not required yet a visit to physician, but she has a feeling it will. She will probably have to go somewhere due to her paralyzed arm, but she had not yet. At the time of the report the event "No control of her arm"/can barely move her right arm; paralyzed at the shoulder from the elbow up; it's numb" had not resolved yet; the event "mild pain at the injection site" resolved on 17Jan2021, the events "Flu like symptoms" and "Threw up a couple times" were recovering and outcome of the events "Numbness has moved up her neck" and "She touches her neck, it hurts a little" was unknown. The reporter assessed the events "Pain injection site" and "Flu like symptoms" as non-serious and assessed the event "Can barely move her right arm; paralyzed at the shoulder from the elbow up; it's numb" as disabling. She assessed all the reported events as related to BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (method of assessment: Global Introspection).; Sender's Comments: Based on the temporal relationship, the association between the events numbness of upper extremity and arm paralysis with BNT162b2 use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 31 | 2021-02-03 | shortness of breath | Day after receiving the vaccine the patient felt SOB and was admitted COVID Positive |
| 31 | 2021-02-08 | sweating, shortness of breath |
Approximately 15 minutes after patient received Pfizer vaccine #1 she began to experience shortness ...
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Approximately 15 minutes after patient received Pfizer vaccine #1 she began to experience shortness of breath, tachypnea, tachycardia, diaphoresis, and hives to upper extremities.
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| 31 | 2021-02-08 | headache, dizziness |
approx. 10 minutes after receiving the vaccine client c/o dizziness and light headedness. a few minu...
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approx. 10 minutes after receiving the vaccine client c/o dizziness and light headedness. a few minutes later started c/o headache and neck stiffening, left side weakness. NP said her left pupil was not responding the same as the right one. Benadryl 50mg Im given, EMSA called and client was transported to hospital.
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| 31 | 2021-02-08 | migraine |
black outs; Severe migraine; full body shakes; soured; delayed jumbled speech; loss of memory; nause...
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black outs; Severe migraine; full body shakes; soured; delayed jumbled speech; loss of memory; nausea; motor control issues; This is a spontaneous report from a contactable consumer reported for herself. A 31-year-old female patient (not pregnant at the time of vaccination and event onset) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration on 25Jan2021 10:00AM at single dose in right arm for covid-19 immunization, immunized in hospital. Medical history included obesity, anxiety, post-traumatic stress disorder (PTSD), insomnia, allergy to walnuts pecans. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonidine, fish oil and multi vitamin. The patient previously received the first dose of bnt162b2 lot number: EL1284, on 04Jan2021 12:00 PM at single dose in left arm for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously also received morphine and codeine, experienced allergy. The patient experienced sever migraine, black outs, full body shakes, soured, delayed jumbled speech, loss of memory, nausea and motor control issues, from 26Jan2021 11:30 PM. The events resulted in emergency room/department or urgent care. It was unknown if treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19. The case was reported as non-serious.
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| 31 | 2021-02-09 | fatigue |
Still getting heat rashes; Had an anaphylactic reaction; Feels tired all day; This is a spontaneous ...
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Still getting heat rashes; Had an anaphylactic reaction; Feels tired all day; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration in arm left on 22Jan2021 09:30 at single dose for COVID-19 immunisation. Medical history included Hashimoto's disease. The patient's concomitant medications were not reported. The patient previously took HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL, number of previous doses: 3), and clindamycin and experienced allergic to clindamycin. The patient experienced an anaphylactic reaction on 22Jan2021 09:45 requiring treatment with an Epipen and transportation to the hospital, heat rashes up until last night 24Jan2021, and felt tired all day in Jan2021. Patient was "worried about how much benadryl" she had been taking. Patient went to the emergency room (ER), received some treatment and was released after 5 hours. She was not fully recovered. She was still experiencing rashes and felt tired all day. Treatment received for events anaphylactic reaction and heat rashes. The patient underwent lab tests and procedures which included blood work: normal on 22Jan2021, and white cell count: slightly increased on 22Jan2021. Outcome of event anaphylactic reaction was resolving, and of other events was not resolved.
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| 31 | 2021-02-21 | chills, throat pain, sweating |
1/26/2021 vaccination 1/27 I got up to breast feed daughter, I could tell I was achy, chills, sweat...
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1/26/2021 vaccination 1/27 I got up to breast feed daughter, I could tell I was achy, chills, sweating. Progressed as day went on. Lasted for approximately 3 days. Sore arm, raised welt on arm at injection site. Sore throat, my lymph nodes were swollen. * 1/8 COVID +
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| 31 | 2021-02-21 | headache |
I woke up the next day with a bad headache; This is a spontaneous report from a contactable consumer...
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I woke up the next day with a bad headache; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration at left arm on 25Jan2021 15:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. No allergies to medications, food or other products. The patient's concomitant medication included Multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient woke up the next day with a bad headache. The event started on 26Jan2021 at 08:00. There was no treatment received for the adverse event. The event was non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient recovered from the event in Jan2021.
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| 31 | 2021-02-21 | influenza like illness |
The night of the second dose of my Pfizer Covid vaccine, my face began to feel hot and tight. The ne...
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The night of the second dose of my Pfizer Covid vaccine, my face began to feel hot and tight. The next day, I began with the expected flu like symptoms of the vaccine, accompanied by a red, fine bumpy rash with some swelling on my face where it had felt hot and tight the evening prior. The flu like symptoms lasted about 24 hours. The facial rash persisted and I began oral antihistamines - diphenhydramine and famotidine. The rash continued for one full week, only improving after beginning to use topical hydrocortisone on my face at the suggestion of a friend who is a nurse practitioner. After improvement in the rash I stopped hydrocortisone and antihistamines. The rash reappeared about 5 days later, and continues to randomly reappear about once a week to every 10 days. Flares only last about 24-36 hours now and will go away without medication but it does clear faster with hydrocortisone and antihistamines. The rash only flares at night, and no triggers like heat, alcohol or certain foods seem to bring it out. I have been consistently taking famotidine and cetirizine daily since the last flare of the rash, and have not experienced a flare again yet.
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| 31 | 2021-02-21 | dizziness, weakness |
blurry vision (now resolved), dizzy/weak, sore arm. Side effects so bad that the patient was unable ...
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blurry vision (now resolved), dizzy/weak, sore arm. Side effects so bad that the patient was unable to drive home from work.
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| 31 | 2021-02-21 | dizziness, fatigue, headache | nausea, vomiting, fatigue, HA, dizziness, Bel's Palsy |
| 31 | 2021-02-22 | dizziness |
Near syncope, dizziness, unresponsive to sternal rub. RRT called and transported to ER where she reg...
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Near syncope, dizziness, unresponsive to sternal rub. RRT called and transported to ER where she regained adequate mentation without intervention.
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| 31 | 2021-02-23 | chills | CHILLS, NAUSEA |
| 31 | 2021-02-25 | shortness of breath, cough |
Light cough; Shortness of breath; Anaphylaxis; lost voice entirely; This is a spontaneous report fro...
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Light cough; Shortness of breath; Anaphylaxis; lost voice entirely; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 11Feb2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history was none. Patient did not have known allergies and did not have COVID-19 prior to vaccination. Concomitant medications included piroxicam (PAXIL) and lisdexamfetamine mesilate (VYVANSE). Patient did not receive other vaccines in four weeks. The patient experienced light cough on 11Feb2021 at 14:45 with outcome of recovering, shortness of breath on 11Feb2021 with outcome of recovering, anaphylaxis on 11Feb2021 with outcome of recovering, lost voice entirely on 11Feb2021 with outcome of recovering. The events required emergency room visit and physician office visit. The patient was hospitalized due to the events in Feb2021 for 1 day. Events were considered life threatening. Clinical course: light cough after half an hour from vaccination. Within 2 to 3 hours had lost voice entirely and was suffering from shortness of breath. Her primary physician told her to go to the emergency room or he was calling an ambulance because he said it sounded like anaphylaxis and that her life was in danger. Therapeutic measures were taken as a result of the events and included treatment with intravenous (IV) Decadron Pepcid and epinephrine. She received the 2nd dose on 21Feb2021 at 01:15 PM. Patient was not tested for COVID-19 post vaccination. The information on the lot/batch number has been requested.
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| 31 | 2021-02-28 | chills, night sweats, headache |
headache; night sweats; achy; chills; last menstrual date 19Dec2020 and first administration date=29...
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headache; night sweats; achy; chills; last menstrual date 19Dec2020 and first administration date=29Dec2020; This is a spontaneous report from a contactable nurse reporting for herself. A 31-year-old pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via an unspecified route of administration on 29Dec2020 at 13:00 (at the age of 31 years old) as a single dose in the left arm for COVID-19 immunisation. Medical history included seasonal allergies from an unknown date, acid reflux disease from an unknown date, headaches from an unknown date, and irritable bowel syndrome from an unknown date. Concomitant medication included pantoprazole sodium sesquihydrate (PROTONIX), prenatal vitamins, cetirizine hydrochloride (ZYRTEC), and unspecified allergy shot. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache on an unspecified date, night sweats on an unspecified date, achy on an unspecified date, chills on an unspecified date, and last menstrual date 19Dec2020 and first administration date of 29Dec2020. The mother was due to deliver on 25Sep2021. The patient did not receive treatment for the events. The outcome of the events headache, night sweats, achy and chills, and exposure during pregnancy was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 31 | 2021-02-28 | fatigue, somnolence, dizziness |
light headed; nervous; really tired; made me really sleepy; i had a few skipped heart beats while la...
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light headed; nervous; really tired; made me really sleepy; i had a few skipped heart beats while laying down; weird/ didn't feel normal; get restless; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9261) via an unspecified route of administration on the left arm on 20Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included having one thyroid and had a benign tumor removed from behind heart when she was young and birth control. Concomitant medication included benzalkonium chloride, sodium chloride (ALIVE) and desogestrel, ethinylestradiol (ISIBLOOM) for birth control. After taking the shot she got light headed as she was walking to her car on 20Jan2021 15:00. Didn't think nothing of it since she was nervous about taking the shot. Then once she got home, she got really tired. She only had one thyroid so the shot made me really sleepy and she had a few skipped heart beats while laying down. After she slept, she felt fine but weird then after being up for a few hours she would get restless again. She got light headed again the next day going to the grocery store then back restless. She didn't feel normal until this Tuesday, she was not feeling weird and she was not as tired as she had been since she took the shot. She had tried to get seen from her doctor but she was booked up. No treatment was received for the events. The facility where the vaccine was administered was in a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was recovering.
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| 31 | 2021-03-02 | dizziness, headache, chills |
Change in menstrual cycle (period came 5 days early and was substantially lighter); body aches; Head...
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Change in menstrual cycle (period came 5 days early and was substantially lighter); body aches; Headache; chills/rigors; painful swollen axillary lymphnodes in affected arm, still swollen 3 weeks later; painful swollen axillary lymphnodes in affected arm, still swollen 3 weeks later; abdominal cramping; lightheadedness; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK4176, expiry date unknown), via an unspecified route of administration on 08Jan2021 at a single dose as a Covid vaccine. Medical history included allergies to penicillin. Prior to the vaccination, the patient has not had COVID-19. There were no concomitant medications. The patient did not receive other vaccines in four weeks or other medications in two weeks. The patient received the first dose of BNT162B2 (lot number: EH9899) on 18Dec2021 at 11:00 AM on the left arm as a Covid vaccine. The patient has not been tested for COVID-19 post vaccination. The patient experienced headache, chills, rigors, body aches, abdominal cramping, lightheadedness, painful swollen axillary lymphnodes in affected arm, still swollen 3 weeks later on 08Jan2021 at 11:00 PM. The patient also experienced a change in menstrual cycle (period came 5 days early and was substantially lighter) on an unspecified date in 2021. The patient did not receive treatment for the events. It was reported that the patient recovered from the events with lasting effects.
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| 31 | 2021-03-03 | chills, fever |
Fever; chills; This is a spontaneous report from a Non-contactable Pharmacist (patient). A 31-year-o...
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Fever; chills; This is a spontaneous report from a Non-contactable Pharmacist (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN5318), via an unspecified route of administration on 01Feb2021 at 10:30 AM (at the age of 31-years-old) at single dose in left arm for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) received on an unspecified date at single dose. The patient was vaccinated at workplace clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included anxiety and known allergies to Sulfa. The patient received no concomitant medications. On 01Feb2021 at 20:00 the patient experienced fever and chills. No treatment was given for the events. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 31 | 2021-03-14 | chills, headache |
woke up at 1am with chills and a headache; woke up at 1am with chills and a headache/felt rundown wi...
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woke up at 1am with chills and a headache; woke up at 1am with chills and a headache/felt rundown with a lingering headache; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 31-year-old via an unspecified route of administration on Left arm on 09Feb2021 09:00 (lot number=EN5318) at single dose for COVID-19 immunisation. Medical history was none. There was no known allergies, no COVID prior vaccination or no COVID tested post vaccination. No other vaccine was received in four weeks. Concomitant medication included iron, ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient previous took her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 31-year-old on Left arm on 16Jan2021 (lot number=EL3248) at single dose for COVID -19 immunisation. The patient felt fine all day, but woke up at 1am 10Feb2021 with chills and a headache (did not check temperature), took paracetamol (TYLENOL) and was able to get back to sleep. In the morning, felt rundown with a lingering headache, took ibuprofen. Around 1pm, symptoms were gone. The events did not result in emergency room or physician office visit. The outcome of the events was recovered on 10Feb2021 13:00.
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| 31 | 2021-03-20 | weakness, shortness of breath, throat swelling |
anaphylactic reaction, difficulty breathing, swollen throat, tight chest, confusion, flushing, weakn...
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anaphylactic reaction, difficulty breathing, swollen throat, tight chest, confusion, flushing, weakness, numb tongue.
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| 31 | 2021-03-22 | headache, fever, fatigue, chills |
Rash broke out over body; Chills; Pins and needles sensation; shaking; Hand is cold; fever; fatigue;...
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Rash broke out over body; Chills; Pins and needles sensation; shaking; Hand is cold; fever; fatigue; headache; pinched nerve; Achy; pain/tingling and numbness in left arm (injection site).; pain/tingling and numbness in left arm (injection site).; pain/tingling and numbness in left arm (injection site).; This is a spontaneous report from a contactable other health professional (other HCP) (patient) reported for herself. A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6203) via an unspecified route of administration at left arm on 26Feb2021 (at 31-year-old at vaccination) at 01:00 PM for COVID-19 immunisation. Medical history included congenital sucrase-isomaltase deficiency (CSID). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264) via an unspecified route of administration at right arm on 03Feb2021 (at 31-year-old at vaccination) at 01:00 PM for COVID-19 immunization. No known allergies. No other vaccine in four weeks. Other medications in two weeks included topirmirate, levonorgestrel (MIRENA, intrauterine device (IUD)) and low-dose naltrexone (LDN). The patient was not pregnant. Facility type vaccine was at hospital. The patient experienced adverse events included: 12 hours: chills, fever, shaking; 24 hours: achy, fatigue, headache wouldn't go away 6 days: Rash broke out over body (have pictures), pain/tingling and numbness in left arm (injection site). Rash responded to diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC), left arm was still tingling and painful on day 7. Almost felt like pinched nerve. Hand was cold. Pins and needles sensation. The adverse event start date was reported as on 04Mar2021 at 06:30 PM. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not resolved. Treatment received for adverse event included OTC treatment with antihistamines; epinephrine (EPIPEN). No covid prior vaccination. No covid tested post vaccination.; Sender's Comments: A contributory role of vaccine BNT162B2 to the reported events rash and chills cannot be excluded based on the plausible temporal relationship and product safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ehics Committees, and Investigators, as appropriate.
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| 32 | 2020-12-31 | fatigue, fever, chills, headache | Headache, Fever, Body Aches, Nausea, Chills, Asthenopia, fatigue for 36 hrs |
| 32 | 2021-01-01 | chills, fever |
Middle of the night woke up shivering, chills, fever, bones ached, could not even lift my arm it was...
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Middle of the night woke up shivering, chills, fever, bones ached, could not even lift my arm it was so sore and under armpit. Symptoms lasted all day. Next night woke up out of sleep symptoms even worse. Next day same symptoms but now a hard ball that hurts formed near clavicle on side of vaccinated arm. Arm, armpit, clavicle area on right side now all hurt.
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| 32 | 2021-01-02 | headache, chills, fever, fatigue | 100.6 fever, headache, chills, fatigue |
| 32 | 2021-01-02 | fatigue |
Bruise, swelling, pain at injection site immediately following administration. Fatigue starting 12 ...
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Bruise, swelling, pain at injection site immediately following administration. Fatigue starting 12 hours after Muscle aches and joint pain 24 hours after
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| 32 | 2021-01-02 | fatigue, nerve pain |
Day 4 after receiving vaccine dose developed nerve pain in the groin and R glute/thigh, as well as f...
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Day 4 after receiving vaccine dose developed nerve pain in the groin and R glute/thigh, as well as fatigue. Sx worsened on day 5, so I had a virtual visit with a medical provider who prescribed me Valtrex x7d to treat suspected Herpes Zoster, which I previously had in my early 20s.
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| 32 | 2021-01-02 | fever, chills | Pain at injection site Chills Low grade fever |
| 32 | 2021-01-02 | chills, headache, runny nose |
Pfizer-BioNTech COVID-19 vaccine EUA Moderate injection site soreness and stiffness, mild body aches...
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Pfizer-BioNTech COVID-19 vaccine EUA Moderate injection site soreness and stiffness, mild body aches, chills, headache and runny nose Symptoms started within 12 hours of receiving.
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| 32 | 2021-01-03 | fever, shortness of breath |
* TESTED POSTIVE FOR COVID ANTIBODIES 06/2020 - 'STILL HAVE RESIDUAL COUGH' 12/21/2020 - VACCINATION...
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* TESTED POSTIVE FOR COVID ANTIBODIES 06/2020 - 'STILL HAVE RESIDUAL COUGH' 12/21/2020 - VACCINATION 12/22/2020 9:30 WERE AT WORK; FELT SUPER FLUSHED, SOB, COULDN'T FOCUS, FELT FEVERISH, FELT NAUSEOUS. OCCUPATIONAL HEALTH REFERRED TO URGENT CARE; DR STATED 'NOT TYPICAL RESPONSE'; COVID TEST; NEGATIVE
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| 32 | 2021-01-03 | discomfort |
C/O heaviness and warmth to neck, shoulder, and back. C/O heart racing- HR 112. BP 143/99. ER diagno...
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C/O heaviness and warmth to neck, shoulder, and back. C/O heart racing- HR 112. BP 143/99. ER diagnosed with allergic reaction- minor. Continue to report warmth and heaviness to mid-upper back.
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| 32 | 2021-01-03 | headache |
I had a sore arm the next day. I had head ache and joint pain but not sure if it's from the vaccine ...
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I had a sore arm the next day. I had head ache and joint pain but not sure if it's from the vaccine or my Chronic condition. I have called my doctor to follow up. Currently taking Prednisone.
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| 32 | 2021-01-03 | chills, fatigue, headache | Injection site soreness, injection site red, hot and hard lump. Headache, fatigue, tiredness, chills |
| 32 | 2021-01-03 | fever, respiratory tract congestion, throat pain, chills |
shaking uncontrollably/she was full of shakes to the point the bed was shaking; chills; Woke up in t...
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shaking uncontrollably/she was full of shakes to the point the bed was shaking; chills; Woke up in the middle of the night; body aches; as painful as a strep infection; sore throat that was as painful as a strep infection/throat feels sore to the point of Strep/Throat soreness: Felt like sharp razor blades; Feels like she is having an extreme immune response; Feels congestion; severe serum sickness/weird serum sickness; high fever/Had a fever over 101; This is a spontaneous report from a contactable nurse(patient). A 32-year-old female patient received BNT162B2(lot number EH9899) via an unspecified route of administration at Arm Left on 21Dec2020 (from 16:30 to 17:00) at the age of 32 years old at single dose for doesn't want to bring COVID home to her family. The medical history included Migraine headaches. The concomitant medications were not reported. The patient had so many immunizations for international travel, had Yellow Fever vaccine, all of the Guardasil vaccines, had MMR vaccine four times because she never developed immunity to it until the fourth round, got a flu shot yearly,got TDap vaccine every five years because she was an HCP, did Emgality shots( not done it this month. Emgality had a protein inhibitor, was supposed to get Emgality shot on 21Dec2020). On 22Dec2020 the patient experienced severe serum sickness, high fever, body aches to the point that she was shaking uncontrollably, sore throat that was as painful as a strep infection; Caller mentioned she was taking tylenl and benadryl for her symptoms. The patient was a Nurse Midwife. She got the vaccine on Monday evening at 4:30PM. Feeling like she was having a weird serum sickness. Woke up in the middle of the night and she was full of shakes to the point the bed was shaking. She had a fever over 101. Felt like she was having an extreme immune response. She was taking Tylenol and Benadryl around the clock. Woke up this morning and her throat feels sore to the point of Strep. Wondering if she need to distance and get some kind of test. Has been wearing a mask all of the time and doesn't know of anyone people who have COVID that she has been in contact with. Feels congestion and sore throat. Shakes and chills: Began at 02:30. Hard core chills and shakes. High fever over 101: same time as chills and shakes. Woke up from a dead sleep. Didn't have a working thermometer but knows her temperature must have been over 101 by the way she felt. She didn't feel that crappy unless her fever is over 101. She can gauge her own temperature. She experienced throat soreness: Felt like sharp razor blades. The patient was taking numbing throat lozenges. Seriousness: Would say serious. Didn't require hospitalization. She self-treated. Had she not had to work, she would probably have stayed in bed. Has been taking round the clock medicine. The outcome of the events was unknown. The information on the batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported serious events including severe serum sickness, high fever, body aches, shaking uncontrollably, sore throat that was as painful as a strep infection, feels like having an extreme immune response, congestion, chills, woke up from a dead sleep and the administration of the COVID 19 immunization with BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to those, as appropriate.
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| 32 | 2021-01-04 | runny nose, skin warm, headache, fatigue, dizziness, chills, throat pain |
12/28 8am- Pfizer vaccine (lot#EL0140) received in L arm at Hospital 12:45pm- out on a walk. Lighthe...
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12/28 8am- Pfizer vaccine (lot#EL0140) received in L arm at Hospital 12:45pm- out on a walk. Lightheaded, fatigue, chills, mild nausea, stomach cramping, and muscle weakness all hit pretty hard at once. Notice slight arm soreness as well. Went back inside and essentially collapsed on the couch 5:30pm- Arm soreness is worse. Chills and lightheadedness only mild now. Fatigue has gone down to where I can resume daily activity 12/29 Wake up with moderate sore throat Stabbing arm soreness at injection site Moderate fatigue and nausea persist. Mild chills. Tried to go for a walk outside and found a 30 minute very slow walk extremely tough 12/30-1/2 Moderate sore throat continues. Other symptoms gone 1/1-2 Arm/ injection site soreness slowly fades 1/2: exercise for the day= 70 min yoga and 7.5 miles of walking. Had a couple glasses of wine at dinner (possibly relevant if issues with vaccine are related to high histamine food issues) 1/3 Moderate headache, fatigue, and muscle aches. Skin feels hot. Sore throat worse than the previous days. Mild runny nose. Severe nausea. Go to Urgent care for COVID test and Zofran Rx. COVID rapid test and PCR test both negative. No fever, higher than usual blood pressure 1/4-5 (current) Nausea lower but still moderate, requiring Zofran. Sore throat persists. Mild fatigue and muscle aches. Skin still feels warm. Mild vertigo during exercise
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| 32 | 2021-01-04 | dizziness |
Also c/o tingling in hands and feet; dizziness; This is a spontaneous report from a non-contactable ...
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Also c/o tingling in hands and feet; dizziness; This is a spontaneous report from a non-contactable other HCP. This other HCP reported for a 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) Intramuscular on 18Dec2020 at single dose in Right arm for covid-19 immunization. Medical history and concomitant drug were not reported. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minutes waiting period after the injection, the patient began to experience dizziness. Also c/o tingling in hands and feet. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Treatment included water, granola bar, and rest. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
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| 32 | 2021-01-04 | dizziness |
DEVELOPED DIZZINESS AND NAUSEA SHORTLY AFTER VACCINATION. WAS BROUGHT BY PRIVATE VEHICLE TO EMERGENC...
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DEVELOPED DIZZINESS AND NAUSEA SHORTLY AFTER VACCINATION. WAS BROUGHT BY PRIVATE VEHICLE TO EMERGENCY ROOM. SYMPTOMS LASTED ~1 HOUR.
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| 32 | 2021-01-04 | chills, fever, headache |
Fever 101.5; body aches; chills; headache; This is a spontaneous report from a contactable other hea...
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Fever 101.5; body aches; chills; headache; This is a spontaneous report from a contactable other health professional (patient). A 32-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on 27Dec2020 08:45 at single dose at right arm for COVID-19 immunization. Medical history reported as none, no Allergies to medications, food, or other products. Concomitant medication was none, the patient did not receive any medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Dec2020 21: 30 (09:30 PM), the patient experienced fever 101.5, body aches, chills, headache. Treatment received for the adverse events included Tylenol. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
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| 32 | 2021-01-04 | throat pain |
Sore throat; This is a spontaneous report from a contactable other healthcare professional (HCP) (pa...
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Sore throat; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 32-year-old female patient received BNT162B2 (lot EK5730) via an unspecified route of administration on 22Dec2020 10:30 AM at a single dose as COVID-19 vaccine. Medical history was not reported. Concomitant medications included lysine supplement and loratadine (other medications in two weeks). The patient had known allergies to amoxicillin. It was reported that the patient had an adverse event of sore throat, 4 days after vaccine on 26Dec2020 14:30 (02:30 PM) assessed as non-serious. It did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). She had no other vaccine within four weeks prior to the COVID vaccine and had no Covid prior to vaccination. She had the Covid tested (other) post vaccination on 23Dec2020 with a negative result. The patient was not pregnant at the time of vaccination. The outcome of the event was unknown.
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| 32 | 2021-01-04 | headache, chills |
Tachycardia (over 100 bpm for 48hr); Nausea; Headache; Chills; arm pain; This is a spontaneous repor...
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Tachycardia (over 100 bpm for 48hr); Nausea; Headache; Chills; arm pain; This is a spontaneous report from a contactable Nurse reporting for herself. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left arm on 18Dec2020 13:00 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included Reynald's, Irritable bowel syndrome (IBS), spontaneous pneumothorax. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergy to medication of Vicodin. The patient experienced tachycardia (over 100 bpm for 48hr), nausea, headache, chills, arm pain, started on 18Dec2020 13:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event Tachycardia was recovered on 20Dec2020 13:00, the outcome of the other event was recovered on an unknown date in Dec2020.
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| 32 | 2021-01-04 | fatigue, fever, chills |
chills; body aches; tender left deltoid injection site pain.; fatigue; elevated temp/ tympanic temp ...
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chills; body aches; tender left deltoid injection site pain.; fatigue; elevated temp/ tympanic temp of 100.8; This is a spontaneous report from a contactable nurse reporting for herself. A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EJ1685, via an unspecified route of administration on 21Dec2020 12:30 as a single dose (dose 1) in the left arm (age at vaccination: 32 years old) for COVID-19 vaccination. The facility where the most recent COVID-19 vaccine was administered wasa hospital. There were no other vaccines given in the 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at the time of vaccination. Medical history included diagnosed with COVID-19 on 06Jul2020, irritable bowel syndrome (IBS), depression, attention deficit hyperactivity disorder (ADD), cervical spondylosis, and herpes simplex virus (HSV); no allergies to medications, food, or other products. Concomitant medication included methylphenidate hydrochloride (CONCERTA), sertraline hydrochloride (ZOLOFT), valacyclovir, levonorgestrel (LILETTA), and colecalciferol (VITAMIN D). The patient woke up at 0400 on 22Dec2020 with tympanic temp of 100.8, chills, body aches, and very tender left deltoid injection site pain. The events were reported as non-serious. Treatment with ibuprofen resolved the elevated temperature, however she spent all of 22Dec2020 with fatigue and body aches despite ibuprofen. The tender left deltoid persisted for a total of 3 days and then became more tolerable, less tender. The clinical outcome of elevated temp/ tympanic temp of 100.8 was resolved on 22Dec2020, of fatigue and body aches was recovered on 23Dec2020, and of chills and tender left deltoid was recovered on an unknown date. Since the vaccination, has the patient has not been tested for COVID-19.
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| 32 | 2021-01-04 | headache |
is nursing twins; is nursing twins; slight headache; arm soreness; This is a spontaneous report from...
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is nursing twins; is nursing twins; slight headache; arm soreness; This is a spontaneous report from a contactable other health professional (patient). This other health professional reported information for both mother and babies. This is the maternal report. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 16Dec2020 11:00 AM at left arm, at single dose for protect as a healthcare provider. Medical history was none. There were no concomitant medications. The patient experienced like arm soreness and slight headache on 16Dec2020, that was pretty much it. Arm soreness started that afternoon on 16Dec2020, she received the vaccine in the morning, at 11am, and maybe like shortly after she noticed, it was there for 1-2 days and went away, and she had since recovered completely. Slight headache started that afternoon on 16Dec2020, and that resolved by the evening, she took Tylenol and it went away. And she was nursing twins, they are about 14 months now. She was aware of the risks of getting it, and the only reason she reported it, is it may be beneficial from a research standpoint, she doubts many lactating mothers, especially twins, are involved. She is personally not concerned, she is probably expecting similar for her second dose, and there is not much research. Her next is dose 06Jan2021. The outcome of the events slight headache was recovered on 16Dec2020, the outcome of the event arm soreness was recovered in Dec2020.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518603 Same reporter/drug, different patient/event. baby case;US-PFIZER INC-2020518630 Same reporter/drug, different patient/event. bady case
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| 32 | 2021-01-05 | chills, fever |
1/7/21 at 08:00 body chills and at 09:30 fever (Tmax 100.5 no meds taken), at time of call 11:00 tem...
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1/7/21 at 08:00 body chills and at 09:30 fever (Tmax 100.5 no meds taken), at time of call 11:00 temperature of 99.1
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| 32 | 2021-01-05 | headache, throat irritation, chills, fever |
12/24 headache, low grade fever, chills took advil. 12/29 2:30am severe reaction of itching aggres...
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12/24 headache, low grade fever, chills took advil. 12/29 2:30am severe reaction of itching aggressively from scalp to toes, broke out in red hives, tachycardic Itchy throat, swollen, ears and lips.
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| 32 | 2021-01-05 | chills, fever, malaise, headache |
Bronchospasm 1.5 hours post injection relieved by 1 puff of albuterol. 12 hours post injection heada...
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Bronchospasm 1.5 hours post injection relieved by 1 puff of albuterol. 12 hours post injection headache. 24 hours post injection chills, aches, malaise, low grade fever. Overall mild discomfort at the injection site.
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| 32 | 2021-01-05 | chills |
Diarrhea, chills, injection site soreness; Diarrhea, chills, injection site soreness; Diarrhea, chil...
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Diarrhea, chills, injection site soreness; Diarrhea, chills, injection site soreness; Diarrhea, chills, injection site soreness; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: Ek9231), via intramuscular route of administration, on 29Dec2020 at 08:45 AM (at the age of 32 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history was none. Past drug history was allergy to Pediazole. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020, at 07:30: AM, the patient experienced diarrhea, chills and vaccination site soreness. No treatment was received for the events diarrhea, chills and vaccination site soreness. The outcome of the events diarrhea, chills and vaccination site soreness was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
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| 32 | 2021-01-05 | fever |
Dose two of the Pfizer vaccine lot: ELU140 administered to right arm at 0800 01/04/2021. Symptoms b...
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Dose two of the Pfizer vaccine lot: ELU140 administered to right arm at 0800 01/04/2021. Symptoms began at 2000 01/04/2021 which are; Fever 101.8, resting heart rate sustaining 140 bpm, right wrist pain and swelling to that joint, right supraclavicular node enlargement, tremors, burning sensation on skin to the entire body, severe headache, weakness, frequent urination, fatigue, eye pain, chills, sweating.
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| 32 | 2021-01-05 | headache, fatigue, chills, fever |
Fever (102 F); Chills; Tired; Muscle aches; Some upset stomach the night of the vaccination (12 hour...
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Fever (102 F); Chills; Tired; Muscle aches; Some upset stomach the night of the vaccination (12 hours after administration); Headache; This is spontaneous report from a contactable other-HCP (patient). A 32-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot: unknown) intramuscularly on 30Dec2020 12:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin (reported as ammoxicillin) and experienced drug allergy. The patient experienced fever (102 F) and chills on 31Dec2020 12:00, muscle aches and some upset stomach the night of the vaccination and headache (12 hours after administration), tired the day after (31Dec2020 12:00). No treatment received for the adverse events. This is a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 31Dec2020. Information on lot/batch number has been requested.
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| 32 | 2021-01-05 | fatigue, headache | Headache, Nausea, Myalgias, Fatigue |
| 32 | 2021-01-05 | chills, headache | Headaches, nausea, chills, vertigo |
| 32 | 2021-01-05 | dizziness | Lightheaded, dizzy, nausea, flushed, dry mouth began about 10 min after vaccination |
| 32 | 2021-01-05 | headache, dizziness |
Mild headache and light headed for around 2 hours. Dry mouth for around 4 hours. I took 500mg Napr...
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Mild headache and light headed for around 2 hours. Dry mouth for around 4 hours. I took 500mg Naproxen for the headache, and drink water for the dry mouth
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| 32 | 2021-01-05 | fatigue, chills |
Nausea and chills starting about 12 hours post injection, lasting a few hours. Fatigue and muscle fa...
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Nausea and chills starting about 12 hours post injection, lasting a few hours. Fatigue and muscle fatigue the day after injection lasting into the second day after injection (today).
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| 32 | 2021-01-05 | dizziness, sweating |
Received Pfizer Lot EL1284 1-6-2021 in right arm 1-6-2021. Went home and started to have light head...
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Received Pfizer Lot EL1284 1-6-2021 in right arm 1-6-2021. Went home and started to have light headedness, sweaty palm, hot flashes. She has been drinking water and ate before and after receiving the shot. No reactions to other vaccinations. Has history of anxiety and depression.
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| 32 | 2021-01-05 | dizziness, fatigue |
Recieved the Pfizer-Biontech Covid-19 vaccination on Dec 26th 2020, and had no major adverse reactio...
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Recieved the Pfizer-Biontech Covid-19 vaccination on Dec 26th 2020, and had no major adverse reaction to vaccine except for mild soreness and heat around injection site and intense fatigue for three days after. Symptoms went away after the 4th day. Two weeks later on Jan 5th 2021, i began to notice an intense itching, burning, and swelling at the injection site. Pain and soreness in arm made it difficult to do my job and seem to just get worse. Upon the next morning of Jan 6th 2021, pain remained but itching had gone down, but intense burning, soreness and massive redness around injection site remained and seemed to be getting worse. Pain remains and redness has not gone down, arm is very tender near site and lifting and moving arm is very stiff and sore. Feeling of lump or stiffness on injection site comes and goes and feeling of heavy and sore muscles move from upper left arm down to elbow and extend to hand; making movement and function slowed or slightly numb. Stiffness in arm and intense heat at injection site makes it uncomfortable to move or use arm. Cold tingling sensation on occasion and stiffness in elbow joint. Slight dizziness and fatigue follow with pain in arm. Was informed to see a physician on Jan 6th, 2021 who said to fill out vaccination adverse event report and to keep an eye on arm. If pain or symptoms become worse to return.
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| 32 | 2021-01-05 | chills, fever, headache |
Slight arm soreness about 12 hours after injection, with severe rigors shortly thereafter. Fever to ...
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Slight arm soreness about 12 hours after injection, with severe rigors shortly thereafter. Fever to 101.8 and uncontrollable shaking/chills, and moderate to severe headache. Rigors lasted about 6 hours, headache persists.
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| 32 | 2021-01-05 | chills, fever | fever chills/rigors body aches within 12 of getting vaccine |
| 32 | 2021-01-05 | dizziness |
left side tingling and numbness, decrease BP and pulse, nausea, dizziness/lightheaded, difficulty an...
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left side tingling and numbness, decrease BP and pulse, nausea, dizziness/lightheaded, difficulty answering questions, itchy-allergic to benadryl so sent to ER for further evaluation
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| 32 | 2021-01-06 | fatigue |
"My arm was sore for the first 24 hours, but the next morning I noticed that my hands were red. Oth...
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"My arm was sore for the first 24 hours, but the next morning I noticed that my hands were red. Otherwise I just felt tired, and my skin felt hypersensitive"
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| 32 | 2021-01-06 | shortness of breath, sweating |
About 5 min after the administration of the second dose of the vaccine I began to experience tachyca...
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About 5 min after the administration of the second dose of the vaccine I began to experience tachycardia, difficulty to breath, sweating, numbness in arms and legs and trembling of limbs. I have not history of allergies.
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| 32 | 2021-01-06 | dizziness |
As soon as I received my shot it was like an electric shot from the injection shot, up the back of m...
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As soon as I received my shot it was like an electric shot from the injection shot, up the back of my neck, into my brain. I was instantly woozy and disoriented. They moved me to observation. My hemiplegic migraine started within 10 minutes of the vaccine. I take a preventative every day, and to be honest after the vaccine it was like I had never, ever taken my preventatives. The migraine I got that day is the worst one I have experienced since the first one I ever got. Now on top of the migraines, the vaccine gave me waves of new symptoms. I was having spells of intense heat flashes, with wooziness, and nausea. So the new symptoms were paired with the hemiplegic migraines that, if you aren?t familiar with, mimic strokes because my whole left side tends to go limp, and I struggle with speech, and cognitive issues. So it really wasn?t all too long before the nurse kindly suggested that I didn?t look great and we should head to the ED. They treated the migraine, gave me a CT, everything came back fine. They reached out to my neurologist, gave me some fluids, really they wanted to keep me a little longer, but I know the migraine drill and just wanted to go home and sleep and eat. I promised to follow up with my neurologist and fill out my CDC form. Over the next week the migraine and extra symptoms seemed to slowly but surely let up. The only note worthy thing was really that my left side would get extra tender at times. Not just my injection site, but it was almost like all my nerve endings all over my left side were on fire at times and a pinch on the thigh may as well have been a stab, or a pat on the back a punch. It was pretty intense at times. And just when I thought it was all over my menses started, you see my hormones trigger my migraines. And once again it was like I wasn?t on a preventative. I had an intense Migraine start. I was able to take my bail out medication (sumatriptan) though and get to work. I moved forward with my day, and just when I thought all was normal, I got one of those brutal heat flashes, the room started moving, and I was nauseous. Unfortunately I was in full PPE, I almost passed out, I had to get a coworker to help, they had to get my supervisor. It was a big, unnecessary-necessary, pride-wounding scene. Now I am not a scientist or a doctor, but I might speculate that people with neurological deficits, like myself, are going to have a harder time with this inactive Covid strand. I would much rather be immune to Covid then catch it though, so whatever I can do to help, and protect myself and family and friends and neighbors, I will absolutely do... But I imagine there is probably an adjustment to be made here for the neurologically impaired. Thanks for your time, and let me know if you have any questions.
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| 32 | 2021-01-06 | fever | Fever 101.2 and body aches the day after receiving vaccine. |
| 32 | 2021-01-06 | headache, fever | Headache, Fever, 99- 100.0 |
| 32 | 2021-01-06 | malaise, fever, headache, chills |
I started having swelling from the shoulder down, I had site soreness nausea vomiting headache chill...
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I started having swelling from the shoulder down, I had site soreness nausea vomiting headache chills fever body aches general malaise lack of appetite, worse than the flu symptoms. I still have some mile symptoms and chills on occasion. The worst of the symptoms is over. I took theraflu and hydrated I only went to the Dr for a note for work
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| 32 | 2021-01-06 | fatigue, headache |
L arm muscle achiness, mild fatigue, mild headache- completely resolved 36 hrs after administration....
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L arm muscle achiness, mild fatigue, mild headache- completely resolved 36 hrs after administration. No treatment.
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| 32 | 2021-01-06 | fatigue, dizziness, malaise | Lightheadedness Fatigue Dizziness Sore arm Nausea Malaise |
| 32 | 2021-01-06 | headache, migraine, malaise | Persist nausea, headaches, migraines, malaise |
| 32 | 2021-01-06 | influenza like illness, headache |
Severe, SEVERE flu like symptoms which nearly prompted a trip to the emergency room. I could not cha...
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Severe, SEVERE flu like symptoms which nearly prompted a trip to the emergency room. I could not change my own clothes my myalgias and joint pain were so severe. I was sobbing in my kitchen and my fiancé had to help me move around the house. I was slowing my speech and mentation. Severe headache. I made my fiancé wake me up every two hours to make sure I wasn?t decompensating.
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| 32 | 2021-01-06 | headache, dizziness, fatigue |
Started with fatigue, dizziness, red face, headache on 1/6/2021 Upon waking on 1/7/2021, Whole body ...
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Started with fatigue, dizziness, red face, headache on 1/6/2021 Upon waking on 1/7/2021, Whole body pains/ aches, soreness in all joints and worse on whole left side of body, extremely tired and headache
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| 32 | 2021-01-07 | chills, fever | 100.8 fever, chills, muscle/joint pain |
| 32 | 2021-01-07 | fatigue, headache, fever |
3 hours after vaccination developed feverish, fatigue, headache and bone ache. Today persist with sa...
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3 hours after vaccination developed feverish, fatigue, headache and bone ache. Today persist with same symptoms
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| 32 | 2021-01-07 | fever, fatigue, chills |
Approximately 13-14 hours after 2nd vaccine dose, developed generalized fatigue, myalgias, chills, a...
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Approximately 13-14 hours after 2nd vaccine dose, developed generalized fatigue, myalgias, chills, and low grade fever (100.6F oral temp). Symptoms largely resolved within 24 hours; however, had persistent eye soreness (pain with lateral movement) through 72 hours post-vaccination for which additional evaluation was sought.
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| 32 | 2021-01-07 | fever, chills |
Body aches, low grade fever, chills 4 days after vaccine; Body aches, low grade fever, chills 4 days...
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Body aches, low grade fever, chills 4 days after vaccine; Body aches, low grade fever, chills 4 days after vaccine; Body aches, low grade fever, chills 4 days after vaccine; This is a spontaneous report from a contactable other HCP (patient). A 32-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685), via an unspecified route of administration on 28Dec2020 09:45 at single dose in the right arm for COVID-19 immunization. Medical history included hypothyroidism from an unknown date. Concomitant medication included levothyroxine and topiramate. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced body aches, low grade fever, chills 4 days after vaccine on 01Jan2021 15:30. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 02Jan2021. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 32 | 2021-01-07 | chills, headache, cough | CHILLS, HEADACHE, BODY ACHE, SORE IN VACCINE AREA, NAUSEA, DIARRHEA,COUGH |
| 32 | 2021-01-07 | chills |
Chills s/p covid vaccine. Denies nausea, dizziness, light headedness, CP, or abdominal pain. No trea...
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Chills s/p covid vaccine. Denies nausea, dizziness, light headedness, CP, or abdominal pain. No treatment required.
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| 32 | 2021-01-07 | fever, headache | Fever, joint pain, back pain, headache Took 800 mg of ibuprofen twice with some symptom relief |
| 32 | 2021-01-07 | fever, headache | Headache, muscle and joint aches, fever, nausea |
| 32 | 2021-01-07 | headache, chills |
Injection site sore, red hot hard; Injection site sore, red hot hard; Injection site sore, red hot h...
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Injection site sore, red hot hard; Injection site sore, red hot hard; Injection site sore, red hot hard; Injection site sore, red hot hard; Chills; Headache; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm on 30Dec2020 14:45 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 20:00, the patient experienced injection site sore, red hot hard, chills, and headache. No treatment was received for the adverse events. Outcome of the events was recovered on an unspecified date. The events were considered non-serious by the reporter.
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| 32 | 2021-01-07 | fever, chills |
Muscle aches, fever, chills. Onset 1/8/21 - employee unable to work next shift due to muscle ache pa...
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Muscle aches, fever, chills. Onset 1/8/21 - employee unable to work next shift due to muscle ache pains
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| 32 | 2021-01-07 | shortness of breath | Numb face, bilateral arm numbness, difficulty breathing |
| 32 | 2021-01-07 | headache, dehydration, dizziness |
ON 1/4/21 AT 4:00PM, DEVELOPED DIZZINESS, CHEST TIGHTNESS, 'HEAVY' ARMS AND LEGS, HEADACHE, HYPERTEN...
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ON 1/4/21 AT 4:00PM, DEVELOPED DIZZINESS, CHEST TIGHTNESS, 'HEAVY' ARMS AND LEGS, HEADACHE, HYPERTENSION (DBP>100). WAS GIVEN 25MG DIPHENHYDRAMINE AT 4:25PM. SENT TO ER AT 5PM. REPORTS SHE WAS SENT HOME FROM ER AT 7:30PM WITH A DIAGNOSIS OF DEHYDRATION. PATIENT REPORTS SHE TAKES A NUMBER OF PSYCHOTROPIC DRUGS, INCLUDING VYVANSE, FLUOXETINE, AND WELLBUTRIN. SHE IS CURRENTLY ON A KETO DIET AND TOOK NAPROXEN EARLIER IN THE DAY.
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| 32 | 2021-01-07 | runny nose |
On the 31st I developed COVID. Runny nose, back ache, and covid symptoms. I still can't smell nor ...
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On the 31st I developed COVID. Runny nose, back ache, and covid symptoms. I still can't smell nor taste.
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| 32 | 2021-01-07 | chills, fatigue, malaise, headache |
Pfizer-BioNTech COVID-19 Vaccine EUA Adverse event: nausea, chills, injection site pain, tiredness, ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Adverse event: nausea, chills, injection site pain, tiredness, headache, muscle pain, feeling unwell Treatment: APAP 1000mg Q6Hrs Time course: injection site pain started ~3hrs after receiving vaccine; chills, headache started ~11-12hrs after vaccine; muscle pain, feeling unwell, nausea, tiredness started ~17-18hrs after receiving vaccine; majority of symptoms improved 48hrs after vaccine administration; some tiredness and feeling unwell remain
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| 32 | 2021-01-07 | chills, fever, headache |
Pfizer-BioNTech COVID-19 Vaccine EUA At 10pm on January 6th she started having chills and a headache...
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Pfizer-BioNTech COVID-19 Vaccine EUA At 10pm on January 6th she started having chills and a headache. She than started with a fever and body aches. Fever 100.5 on 1/7/21 after Tylenol. Symptoms are still persisting. temp was 99.5 this morning 1 hour after taking Tylenol.
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| 32 | 2021-01-07 | fever, headache, chills |
Pfizer-BioNTech COVID-19 Vaccine EUA on January 6th at 10:00pm individual started having chills. She...
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Pfizer-BioNTech COVID-19 Vaccine EUA on January 6th at 10:00pm individual started having chills. She then started having a headache, fever, and body aches. Temp yesterday was above 101 with the use of Tylenol. Today her symptoms are persisting and temp was 99.5 1 hour after Tylenol.
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| 32 | 2021-01-07 | migraine, headache | Pfizer-BioNTechCovid-19 vaccine EUA. Headache and migraine lasting approximately 36 hours. |
| 32 | 2021-01-07 | chills, headache, headache, fatigue, chills, fatigue |
Received 2nd dose of Covid vaccine on 1/6. On 1/7 at 0130 woke up with chills, severe headache, and ...
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Received 2nd dose of Covid vaccine on 1/6. On 1/7 at 0130 woke up with chills, severe headache, and body aches, but no fever. She took Advil, which helped but on 1/8 she still has headache and fatigue.
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| 32 | 2021-01-07 | throat irritation, somnolence |
Recieved 2nd dose of COVID-19 vaccine at 7:56am. Walked back to clinic . Around 0900 started feelin...
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Recieved 2nd dose of COVID-19 vaccine at 7:56am. Walked back to clinic . Around 0900 started feeling throat tightening and throat itching, reports bilat hand felt numb. Walked back to vaccine clinic with co-worker . Reports ALG to Amoxicillin=rash/throat swelling. Employee A/O x 4, color pink, no difficulty breathing, tongue not swollen, but anxious. Moved to Employee Health Services (EHS) for observation are via w/c. Given 50 mg of po Benadryl. VS and pulse ox monitored. V/S and O2sat remained with normal limits. At 11:00am, Employee reported the her throat swelling and itchiness had resolved. D/C home, escorted by husband (HCW). Follow-up call made by health care provider at 17:36pm, employee reported her symptoms had resolved and she took a long nap.
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| 32 | 2021-01-07 | chills, fever | Severe chills lasting 4 hours, fever of 101.1, body aches |
| 32 | 2021-01-07 | lethargy, fever |
Severe lethargy, muscle aches/pains, and fever (101.2F) starting about 12 hours post vaccine. Fever ...
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Severe lethargy, muscle aches/pains, and fever (101.2F) starting about 12 hours post vaccine. Fever reached a max of 105.4F at one point but generally held around 102.2F without use of Acetaminophen. Symptoms started subsiding around 36 hours post vaccine.
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| 32 | 2021-01-07 | fever, headache, fatigue, chills | Sore arm, headache, fever, chills, body aches, fatigue |
| 32 | 2021-01-07 | fatigue | Unilateral facial edema/puffiness, fatigue, tenderness at the injection site |
| 32 | 2021-01-07 | chills, fever |
fever and chills. i took medication to help with the fever and it did work. no medication was helpin...
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fever and chills. i took medication to help with the fever and it did work. no medication was helping my symptoms
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| 32 | 2021-01-07 | fever |
just shy of 24hrs after the vaccine, I developed bone/ joint pain in hips and shoulders, myalgias an...
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just shy of 24hrs after the vaccine, I developed bone/ joint pain in hips and shoulders, myalgias and a fever. Pain in my hips affected my ability to walk/gait. Pain was 8/10, constant, achy and throb; just shy of 24hrs after the vaccine, I developed bone/ joint pain in hips and shoulders, myalgias and a fever. Pain in my hips affected my ability to walk/gait. Pain was 8/10, constant, achy and throb; myalgia; fever; Pain in my hips affected my ability to walk/gait; Pain was 8/10, constant, achy and throbbing; This is a spontaneous report from a contactable physician. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1685 expiration date unknown), intramuscularly, on an unspecified date in Dec2020 at 17:00 (at the age of 32-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history was not provided. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Just shy of twenty-four hours after receiving the vaccine, the patient developed bone/ joint pain in hips and shoulders, myalgias, a fever and pain in her hips which affected her ability to walk/gait. Her pain was 8/10, constant, achy and throbbing. Movement and sitting in the same position exacerbated the symptoms. The patient specified that she did not receive any treatment for the events. She did mention, however, that a hot shower and sleep eased her symptoms. The clinical outcome of bone pain, joint pain, myalgia, fever, pain and difficulty in walking was reported as self-limited and resolved completely within 12-14 hours. It was also reported that since the vaccination the patient had not been tested for COVID-19.
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| 32 | 2021-01-08 | sweating |
0820 received vaccine 0830 reported feeling hot, tingly, sweaty 0835 elevated BP, elevated HR - plac...
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0820 received vaccine 0830 reported feeling hot, tingly, sweaty 0835 elevated BP, elevated HR - placed in supine position, offered oral fluid 0840 continued elevated BP, elevated HR - continued to monitor 0915 continued elevated BP, elevated HR - continued to monitor 0930 reported feeling hot, tingly, sweaty with position change from supine to sitting, BP reduced, HR WNL 0935 transported to ED for continue symptoms > 1 hour post administration
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| 32 | 2021-01-08 | fever, chills, fatigue |
1. Injection site pain: started soon after injection continued to get worse until 1 day after inject...
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1. Injection site pain: started soon after injection continued to get worse until 1 day after injection then progressively got better 2. Fever: t-max 38.2 orally noted at 0430 1/6/21. Fevers associated with chills and rigors at times. 3. Extreme joint and body aches: started early morning 1/6/21 and progressively got worse until 1/7/21 then got better with subsiding around 1/8/21. Pain preventing/limiting normal movements such as walking, turning, and weight baring. 4. Extreme fatigue: sleeping for 18-20 hours a day with hard to stay awake 1/6/21-1/8/21. Resolved by 1/9/21.
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| 32 | 2021-01-08 | somnolence |
1352 - Pt reports upper lip swelling, unable to see on visual assessment, BP-141/92, 100% on RA, T ...
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1352 - Pt reports upper lip swelling, unable to see on visual assessment, BP-141/92, 100% on RA, T - 98.1, HR - 91, RR - 16. Given 25 mg of oral benadryl per this RN per vaccination clinic standing order. 1403 - Pt reports feeling no change from initial report but does note "some finger tingling". 92% on RA, HR - 88. 1410 - Discussed taking a 2nd 25mg dose with patient. Will hold at this time, she states "my hands normally feel puffy when this gets worse but they feel normal now". Pt reports upper lip swelling feels "puffy" but unchanged from initial report. 1418 - Pt reports upper lip swelling increased, BP - 140/85, HR - 80, RR 16, 100% on RA, 25mg of oral benadryl given. 1423 - Pt reports upper lip "puffiness" with slight improvement, new c/o upper back itchiness, no rash or hives visualized on assessment 1428 - Pt reports improvement to feeling of "puffiness", back itchiness remains the same, and pt "feels sleepy" 1438 - Pt reports resolution of upper lip swelling and says "It feels like when I came in", slight back itchiness still present 1448 - Pt reassessed 30 min post 2nd dose of benadryl, pt reports complete resolution of all symptoms, BP - 135/79, T - 98.2, RR - 14, HR - 78, 100% on RA Discussed transportation with patient prior to providing 2nd dose of Benadryl, Pt home via private vehicle with mother (driver) and partner. Educated patient to call nurse on call number with any further concerns or if symptoms resume.
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| 32 | 2021-01-08 | throat irritation |
After 10 minutes, throat began to become numb/tingly/itchy. Then at 20 minutes, I started to have di...
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After 10 minutes, throat began to become numb/tingly/itchy. Then at 20 minutes, I started to have difficulty swallowing. I told the medical provider who was there in the observation room. My vitals were stable. They sent me to the ER to be watched and observed for 6 hours. my throat's numb/itchiness/tingling went away, but remained difficult to swallow until the next morning. My vitals stayed stable.
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| 32 | 2021-01-08 | throat irritation, cough, throat pain, shortness of breath |
Approx 5-6 hours after vaccination she felt an itchy throat and broke out in hives on chest and legs...
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Approx 5-6 hours after vaccination she felt an itchy throat and broke out in hives on chest and legs. She took benadryl and this resolved. Approx 24 hours later she started with sore throat and cough and mild SOB.
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| 32 | 2021-01-08 | lethargy, chills, headache | Chills, body aches, lethargy, headache, entire left arm pain |
| 32 | 2021-01-08 | fever, chills, headache |
Fever, chills, headache, joint pain, injection site soreness, nausea, vomiting, muscle pain and weak...
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Fever, chills, headache, joint pain, injection site soreness, nausea, vomiting, muscle pain and weakness, abdominal pain. Difficulty getting out of bed and poor oral intake. Took 3000 mg acetaminophen and 500mg naproxen. Lasted 5am-7pm on 01/08/2021 currently severe side effects subsided to minimal side effects.
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| 32 | 2021-01-08 | chills | General body aches and chills, nausea lasting 72 hours |
| 32 | 2021-01-08 | headache |
Headache & NauseaVomiting Narrative: Developed symptoms of nausea and headache several hours after v...
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Headache & NauseaVomiting Narrative: Developed symptoms of nausea and headache several hours after vaccine administration (12-22-20). Up late with symptoms of vomiting. Missed work the next day (12-23-20). Feeling much better by noon of the next day.
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| 32 | 2021-01-08 | headache, fatigue, fever, malaise |
Headache, Myalgia, Fever, Fever 101.6 ay 8:00PM, Fatigue-Fever and fatigue lasted the longest-5 days...
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Headache, Myalgia, Fever, Fever 101.6 ay 8:00PM, Fatigue-Fever and fatigue lasted the longest-5 days Narrative: Did not feel well with the fever and fatigue.
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| 32 | 2021-01-08 | headache, fever, chills, shortness of breath |
On 12-26-2020 I started to have fever, chilis, loss of taste and headaches. I got diagnosed with Cov...
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On 12-26-2020 I started to have fever, chilis, loss of taste and headaches. I got diagnosed with Covid on 12-29-2020. I habe lingering of shortness of breath.
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| 32 | 2021-01-08 | chills, fatigue, headache, fever | Severe body aches, fatigue, headache, chills, fever. |
| 32 | 2021-01-08 | weakness, dizziness |
Shortly after vaccine admin, patient reported feeling dizzy. Patient appeared pale. Assist x2 into r...
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Shortly after vaccine admin, patient reported feeling dizzy. Patient appeared pale. Assist x2 into recliner chair and was physically weak. Reclined and provided water and snacks. Patient progressively felt better with 35 min observation, felt "normal" at discharge from clinic.
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| 32 | 2021-01-08 | dizziness, headache, fatigue |
extreme tiredness, headache, left side tingling/numbness (left arm to left jaw), dizziness and near ...
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extreme tiredness, headache, left side tingling/numbness (left arm to left jaw), dizziness and near syncope, body spasms, and left sided chest pain (worse with palpation)
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| 32 | 2021-01-09 | dizziness |
About 5 minutes after receiving my second dose I became flush, and hot from the outside in over my w...
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About 5 minutes after receiving my second dose I became flush, and hot from the outside in over my whole body. I was tingly all over. I felt shaky and like I was going to pass out. Very nauseous. My blood pressure was 169/93 @ 0830. The staff had me lay down. About 5 min later I started to feel better. Another 5 min later it happened again in a wave. The symptoms just came over me. My blood pressure @ 0840 was169/104. The staff had me drink water and rest. @0900 the wave came over me again. My BP was 178/111. I drank more water and rested. BP recheck @ 0925 162/112. @940 BP was slowly coming down at 145/109. At that time they transferred me to the Emergency room. My BP came back into normal ranges, and the waves stopped happening around 12pm. I was then released home with plans to follow up with Primary care on 1/11/2021
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| 32 | 2021-01-09 | chills, fever, fatigue | Chills, fever of 102, body aches, and fatigue. |
| 32 | 2021-01-09 | headache, fatigue, chills | Fatigue, body aches, headache, chills. |
| 32 | 2021-01-09 | malaise, fever, chills | Fever, chills, malaise |
| 32 | 2021-01-09 | chills, headache, fever | Low grade fever, Chills, Headache. Improved with Tylenol initially. Resolved after 12 hours. |
| 32 | 2021-01-09 | headache, fever, chills | Myalgias, fevers, chills, headache |
| 32 | 2021-01-09 | headache, fatigue, body temperature increased, chills |
On 1/7/20 at 8:00 pm had chills and then took Motrin for chills/shivering. 30 minutes later, checked...
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On 1/7/20 at 8:00 pm had chills and then took Motrin for chills/shivering. 30 minutes later, checked temperature and it was 100.3 with blankets on. Removed blankets and temp was 99.3. Fatigue with headache the next day on 1/8/20. On 1/9/20 at 2:00 am, had chills and temp 100.8 with blankets on. Removed blankets and temp was 99.5. Resolved with Tylenol. No other symptoms after this time.
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| 32 | 2021-01-09 | malaise, fatigue, cough, throat pain |
Tested for covid dec 22- negative, no symptoms Vaccine taken on dec 23 Extremely sick dec 31, teste...
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Tested for covid dec 22- negative, no symptoms Vaccine taken on dec 23 Extremely sick dec 31, tested positive for covid. Sore throat, muscle aches, cough, fatigue
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| 32 | 2021-01-09 | chills, nasal congestion, fatigue | chills, entire right arm sore, swollen/painful lymph nodes in right axillary, fatigue, stuffy nose |
| 32 | 2021-01-10 | fatigue, headache |
1/11 "less than 24 hrs, work Sunday night, hands were red, right one swollen. Continued on and off a...
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1/11 "less than 24 hrs, work Sunday night, hands were red, right one swollen. Continued on and off at work when benadryl and chlortabs started wearing off. As night continued y face is a little swollen, headache, hypersensitive skin, sore tired"
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| 32 | 2021-01-10 | fever, chills | Chill Fever Body ache Flank pain |
| 32 | 2021-01-10 | chills |
Chills and body aches about 12 hours after vaccine. These symptoms lasted one day. Acetaminophen he...
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Chills and body aches about 12 hours after vaccine. These symptoms lasted one day. Acetaminophen helped with symptoms.
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| 32 | 2021-01-10 | headache, chills, fatigue, influenza like illness |
Felt like I had the flu the day after I received my second dose. Headache, body ache, fatigue, chill...
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Felt like I had the flu the day after I received my second dose. Headache, body ache, fatigue, chills, nausea. Last about 12 hours.
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| 32 | 2021-01-10 | chills, fever | Fever >102F, rigors, chills, myalgias |
| 32 | 2021-01-10 | headache, head discomfort |
HEADACHE - CONSTANT THROB - FEELS LIKE PRESSURE HAS NOT STOPPED SINCE DAY OF INJECTION. NO OTHER SI...
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HEADACHE - CONSTANT THROB - FEELS LIKE PRESSURE HAS NOT STOPPED SINCE DAY OF INJECTION. NO OTHER SIDE EFFECTS
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| 32 | 2021-01-10 | fatigue | Soreness to Left arm lasted for 48 hrs Fatigue started 12 hrs after and lasted for 36 hrs |
| 32 | 2021-01-10 | fever |
Swelling with localized fever, itching and quarter-silver dollar sized lump under skin after initial...
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Swelling with localized fever, itching and quarter-silver dollar sized lump under skin after initial swelling and lump at injection site had subsided
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| 32 | 2021-01-10 | throat irritation |
The patient received Pfizer's COVID vaccine at 12:22pm. They returned to the pharmacy at 1:20pm repo...
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The patient received Pfizer's COVID vaccine at 12:22pm. They returned to the pharmacy at 1:20pm reporting she couldn't clear her throat and her tongue felt "tingly". They estimate this started around 12:55pm. EMS was contacted once the patient returned to the pharmacy. The patient was monitored. No medications were administered. EMS arrived at 1:29pm and the patient left with them.
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| 32 | 2021-01-10 | fatigue, dizziness |
Vaccine at 600pm on 1/7. Waking up every hour from 330am-800am. Woke up 8am chest scratchiness/itchi...
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Vaccine at 600pm on 1/7. Waking up every hour from 330am-800am. Woke up 8am chest scratchiness/itchiness, generalized joint pain, and body aches, and fatigue. Episode of lightheadedness at around 6pm and near syncope. Started experiencing axillary swelling and pain. All symptoms resoled by 1/9 except for L axillary swelling which persisted until 1/11.
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| 32 | 2021-01-10 | headache, chills, fatigue, fever |
fatigue headache fever chills diarrhea vomiting body aches left lymph node is swollen still after th...
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fatigue headache fever chills diarrhea vomiting body aches left lymph node is swollen still after three days
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| 32 | 2021-01-10 | headache, weakness, fever, chills | fever, chills, headache, and extreme weakness. Some nausea. |
| 32 | 2021-01-10 | fatigue | ongoing swelling of left axillary - underarm pain and swelling tiredness |
| 32 | 2021-01-10 | fatigue, headache, chills |
starting 12.5 hours post vaccine - chills, headache, body aches, nausea, rash at injection site, fat...
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starting 12.5 hours post vaccine - chills, headache, body aches, nausea, rash at injection site, fatigue. Chills and headache resolved after 24 hours. Other symptoms still present 36 hours later. Treated with tylenol.
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| 32 | 2021-01-11 | dizziness |
8 min after administration, described a light-headedness and sinus pressure. Also hypertensive. 144/...
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8 min after administration, described a light-headedness and sinus pressure. Also hypertensive. 144/91 immediately, then 129/88 2 min later. Symptoms resolved around 5 min later, other than some dizziness when trying to stand. Resolved after 20 minutes.
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| 32 | 2021-01-11 | fatigue, headache, sweating, chills |
Around 2pm on 1/9/21, I started to have mild abdominal discomfort. Later on that day started to have...
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Around 2pm on 1/9/21, I started to have mild abdominal discomfort. Later on that day started to have a headache. Took Tylenol 1gm, which helped with headache. Approximately at 1:45am on 1/10/21, I started to feel chills body aches, fatigue, abdominal pain, headache, arm pain on the injection site. Took Tylenol 1gm with Benadryl 50mg. Felt my body sweating. Woke up still with chills, and fatigue. Headache was intermittent throughout the day. Took Tylenol 1gm one time at night woke up on 1/11/21 without symptoms except for the arm pain.
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| 32 | 2021-01-11 | dizziness, headache, sweating | Becoming acutely dizzy, light headed, nausea, head ache, diaphoretic, feeling like about to faint |
| 32 | 2021-01-11 | dizziness | DIZZY, HEAD FOG, VERTIGO APPROXIMATELY 8 HRS INTO IT |
| 32 | 2021-01-11 | fever, chills, fatigue |
Developed fever, chills, aches, fatigue approximately 12 hours post vaccine. unable to report to wo...
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Developed fever, chills, aches, fatigue approximately 12 hours post vaccine. unable to report to work the day after vaccine administered
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| 32 | 2021-01-11 | fatigue, dizziness | Dizziness, rash on legs , tiredness |
| 32 | 2021-01-11 | fatigue | Fatigue, muscle ache, body ache |
| 32 | 2021-01-11 | chills, fever |
Fever, pain, chills for two days. Then an enlarged lymph node over my clavicle, pressure and pain in...
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Fever, pain, chills for two days. Then an enlarged lymph node over my clavicle, pressure and pain in my neck and above clavicle, lymph node is still swollen and tender 4 post injection.
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| 32 | 2021-01-11 | headache, fatigue | HA, body aches, fatigue |
| 32 | 2021-01-11 | headache, fatigue |
Headache behind my eyesTiredness; Headache behind my eyesTiredness; This is a spontaneous report fro...
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Headache behind my eyesTiredness; Headache behind my eyesTiredness; This is a spontaneous report from a contactable healthcare professional. A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 12:00 at single dose for covid-19 immunisation. Medical history included gastrooesophageal reflux disease and known allergies: Penicillin. Concomitant medication included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and oxymetazoline hydrochloride (CLARITIN ALLERGIC). The patient has known allergies: Codeine. The patient stated, "headache behind my eyes tiredness", on 04Jan2021 12:15, The outcome of the events was recovering. Information lot/batch number has been requested.
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| 32 | 2021-01-11 | fever | I started running a fever and body ache after vaccine. On 27th loss taste and smell. |
| 32 | 2021-01-11 | fatigue |
Left axillary lymph node swelling and pain lasting 3+ days, deltoid pain at injection site (2 days),...
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Left axillary lymph node swelling and pain lasting 3+ days, deltoid pain at injection site (2 days), general body aches, fatigue (3+ days).
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| 32 | 2021-01-11 | headache | Nausea, headache, itching, body aches. |
| 32 | 2021-01-11 | dizziness, throat swelling, weakness |
Started to feel lightheaded, weak, faint like I was going to pass out, heart rate increased, confusi...
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Started to feel lightheaded, weak, faint like I was going to pass out, heart rate increased, confusion, trouble speaking, brought to the ED, throat started to swell and started having thick spit and clearing my throat excessively. Diagnosed as anaphylaxis.
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| 32 | 2021-01-11 | headache, fatigue |
Twelve hours after dose: headache, diarrhea, myalgia, cervical lymphadenopathy, nausea, fatigue. Sid...
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Twelve hours after dose: headache, diarrhea, myalgia, cervical lymphadenopathy, nausea, fatigue. Side effects improved by 48 hours after injection and completely resolved by 72 hours after injection.
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| 32 | 2021-01-11 | headache | Vertigo, headache, muscle aches, injection site pain. |
| 32 | 2021-01-11 | fatigue, fever | sore arm, could barely move her arm, fatigue, fever 100.5, vomiting diarrhea |
| 32 | 2021-01-11 | throat pain | sore throat; covid negative |
| 32 | 2021-01-11 | fever, chills, headache, throat swelling |
within 1 hr post-vaccine on 1/7 I had a mild headache that resolved with Tylenol. At about 12 hours ...
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within 1 hr post-vaccine on 1/7 I had a mild headache that resolved with Tylenol. At about 12 hours post-vaccine I developed nausea, fever (100.4) and chills and secondary to this had poor sleep. The next day I took scheduled alternating Tylenol & ibuprofen during the day and then overnight 1 episode of chills that woke me up. no events Saturday or Sunday. Then Monday 1/11 in the early morning I started to develop a rash on my b/l elbow and right foot 3rd toe. I applied mometasone topical cream to these locations. while at work the rash extended down both forearms then by 5pm it was on both hips and extending along both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the itching woke me up. I repeated Benadryl 25mg at 8am. The rash seems to be getting better on the arms but then by noon I had a new breakout on my neck and face. I took Benadryl 50mg at 1pm. The rash continued to have a rapid progression over the next hour and resulted in angioedema with my throat swelling, lips puffed and numb and eye swelling. I was injected with an epi pen and sent to the ED where I received PO prednisone, famotidine, and Benadryl. The face/neck rash then greatly improved and I was sent home on prednisone 40mg daily for 3 days.
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| 32 | 2021-01-12 | fever |
1/11- starting spotting off cycle 1/12 Woke up at 12:30am due to fully body aches, chills and fever...
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1/11- starting spotting off cycle 1/12 Woke up at 12:30am due to fully body aches, chills and fever. 7:45am had fever of 102.2 body aches and leg cramps, 2:00pm had fever of 102 and body aches. 10:00pm still had body aches and fever. 10:00am took Tylenol, fever broke to 100.5 still body aches and leg cramps came back.
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| 32 | 2021-01-12 | dizziness |
About 15 minutes after receiving the second dose of the Pfizer vaccine at Clinic, patient began comp...
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About 15 minutes after receiving the second dose of the Pfizer vaccine at Clinic, patient began complaining that she was dizzy and nauseated. Patient was seated on the exam table at this time, and was helped to lay down on the exam table. Vitals were obtained by RN. Patient began complaining of tingling of her lips while vitals were being obtained at 1110. PA was notified and brought to the room to evaluate patient. Patient denied having any difficulty breathing or swallowing, was not experiencing any itching of the mouth, tongue or throat, and did not notice anything else unusual, patient was still dizzy and nauseated. Patient stated that she had a similar reaction to the first dose of the Pfizer COVID vaccine, where the symptoms resolved within about an hour. Nursing staff and PA stayed with patient during the duration of her observation. Patients vitals ranged betwen pulse ox = 98-99%, pulse = 97-106 bpm, B/P = 114-121/80-89 mm hg. Patient also complained of some tingling around the lower jaw at 1147. Patient was observed for 1 hour and 26 minutes after vaccination was received. Symptoms gradually resolved, upon discharge patients lightheadedness had resolved, and the tingling around the lips and jaw were mostly gone. Patient still was not having any shortness of breath, chest pain, trouble breathing, rash or hives, swelling/tingling/numbess of the tongue, mouth, or throat. Discharge instructions were provided by PA, including when to seek further care at the ER or to call 911. Patient felt comfortable driving herself home and left at 1214. About two hours later, pt presented to ED. Pt endorsed throat tingling, lightheaded, nausea. She also stated that while the reaction post Dose 1 and Dose 2 were similar, the reaction after Dose 2 was much more severe. Assessed for transient Bell's Palsy presentation but determined unlikely as no facial asymmetry or deficits were appreciated. RR 24, other vitals WNL. Pt observed for about 1.5 hours before discharging home with instructions to call ED should condition worsen.
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| 32 | 2021-01-12 | headache |
About 24 hours after the vaccine injection felt like something stuck in throat and chest hurt. Progr...
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About 24 hours after the vaccine injection felt like something stuck in throat and chest hurt. Progressed in 30 minutes to pain in chest and head, swallowing painful, whole body and eyes itching and felt irritable. Symptoms continued for 24 hours.
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| 32 | 2021-01-12 | shortness of breath, fever |
Beginning on 1/5 at 8 am Fever 101, body aches chills. (expected reaction), however over the course ...
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Beginning on 1/5 at 8 am Fever 101, body aches chills. (expected reaction), however over the course of the next 3 days, short of breath with minimal exertion, increased heart rate to 150 with minimal movement. Resolved symptoms on 1/10.
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| 32 | 2021-01-12 | chills, headache, fever, sweating |
Estimated due date: 06/14/2021 On 12/27 I woke up with headaches, I had headaches until the 30th. On...
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Estimated due date: 06/14/2021 On 12/27 I woke up with headaches, I had headaches until the 30th. On 12/28 my son was tested positive for covid. I tested negative on the 20th and 30th. My symptoms started getting worse (loss of taste and smell) and 01/06 I tested positive. 01/11 at 5PM I had my second dose. I had some body aches and fever (101.5F). chills, sweats and Tylenol and it was not making a difference. Last night around 8PM my temp was to 100.8F and today I woke up and temperature normal and body aches much better.
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| 32 | 2021-01-12 | fever, fatigue | Fatigue, body aches, fever, chills |
| 32 | 2021-01-12 | fatigue |
Fatigue; first dose of BNT162B2 on 17Dec2020 then second dose on 05Jan2021; This is a spontaneous re...
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Fatigue; first dose of BNT162B2 on 17Dec2020 then second dose on 05Jan2021; This is a spontaneous report from a non-contactable physician. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), intramuscular on 05Jan2021 at 13:00 (second dose) on the left arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not also receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within two weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 17Dec2020 at 13:00 on the left arm for COVID-19 immunization. On 05Jan2021 at 14:00, the patient experienced fatigue. The patient was given Tylenol as treatment for fatigue. The outcome of the event fatigue was recovered with sequel on an unspecified date in Jan2021. No follow-up attempts are possible. No further information is expected.
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| 32 | 2021-01-12 | migraine, fatigue, fever |
Fever 101; fatigue; nausea; migraine; This is a spontaneous report from a contactable Nurse(patient)...
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Fever 101; fatigue; nausea; migraine; This is a spontaneous report from a contactable Nurse(patient). A 32-years-old female patient received BNT162B2(Lot number: EK9231) , intramuscular on 06Jan2021 08:15 at 32 years old at Arm Right at single dose for COVID-19 immunization. Medical history included migraine, Allergies to Latex. Concomitant medications included asa, ascorbic acid (VIT C), cetirizine hydrochloride (ZYRTEC) and ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (Multi Vit). The patient experienced fever 101, fatigue, nausea, migraine on 06Jan2021 19:00. There was no treatment received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 06Jan2021. The outcome of events was recovering.
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| 32 | 2021-01-12 | fatigue, headache |
Got menstrual cycle like almost two and a half weeks early; Abdominal pain radiating to upper and mi...
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Got menstrual cycle like almost two and a half weeks early; Abdominal pain radiating to upper and middle back; Abdominal pain radiating to upper and middle back; Stomach cramps; Nausea; Fatigue; Headache; Sinus infection; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (04Jan2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on the left deltoid on 15Dec2020 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included irritable bowel syndrome. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), famotidine (PEPCID), ethinylestradiol, norgestimate (CILIQUE) for birth control and multivitamin. It was stated that the patient got the vaccine on 15Dec2020. On 17Dec2020, she developed severe abdominal pain radiating to her upper and her middle back with pretty bad nausea, fatigue and headache. It was also mentioned that the patient had stomach cramps. These continued all the way until like Christmas. And then on the 19Dec2020, she actually got her menstrual cycle though she was not due to start that till that week. So, it came like almost two and a half weeks early (which was super weird as for her). The patient took ondansetron (ZOFRAN) for the nausea; aluminium hydroxide, magnesium hydroxide (MAALOX); famotidine and hyoscyamine for like stomach cramping. She also took that as well, acetaminophen (TYLENOL) and ibuprofen (MOTRIN). It was mentioned that the symptoms stopped on 26Dec2020 then she sinus infection right after in Dec 2020. Outcome of the event of sinus infection was unknown while the remaining events recovered on 26Dec2020. The patient stated that the she don't think that sinus infection was correlated at all but all other symptoms were happening right after the vaccine (reported as related). Information on the lot/batch number has been requested.; Sender's Comments: The event sinus infection is likely intercurrent and is unrelated to suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 32 | 2021-01-12 | headache |
Headache began the next morning and had been returning daily with pain and pressure behind the eyes....
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Headache began the next morning and had been returning daily with pain and pressure behind the eyes. Some sinus inflammation but clear discharge. Swollen lymph node on left side of neck started 1/10 with minor pain.
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| 32 | 2021-01-12 | shortness of breath, cough |
I waited for a total of 15 mins at clinic as requested for side effects. After the 15 mins past, I w...
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I waited for a total of 15 mins at clinic as requested for side effects. After the 15 mins past, I went to my car. By the time I got to my car (about 5 mins later at the most), my face felt flush and I had shortness of breath and began coughing. I then used my emergency inhaler for asthma and was able to breathe better. I went back inside clinic to be monitored by a doctor. The coughing continued and resided after about15 -30 minutes. My blood pressure was normal per the doctor and my breathing returned to normal per the doctor.
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| 32 | 2021-01-12 | weakness |
I work as an occupational therapist in acute care. On 12/28, I was helping a patient transfer from s...
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I work as an occupational therapist in acute care. On 12/28, I was helping a patient transfer from supine to sit. She required maximal assistance, and I was briefly in an awkward position with my trunk flexed and rotated towards the right during this transfer. I felt a pull in my left lower back. After this, I iced the area and took 400 mg ibuprofen and this relieved the mild pain I had. The following two days, I made an effort to follow back precautions (avoid bending, lifting, twisting), avoided heavy lifting at work. On 12/29 in the morning, I felt only a mild soreness in my left lower back and was able to go on my workday without issue (avoiding heavy lifting) On 12/29 around 3 pm I received the first dose of the Pfizer COVID vaccine. On 12/30 (day off work) from the time I woke up until around early afternoon I felt a mild weakness and heaviness in both of my legs. It was most notable when I was standing to cook for about 20-30 minutes that my legs felt shaky and I felt the need to sit. I was able to finish cooking without sitting, however, this sensation was abnormal for me as I normally am on my feet for most of the day with an active job without feeling shaky or weak. Around 22:00 on 12/30 I had severe nausea for about an hour or so. I can't fully remember, but several days after 12/28 or 12/29 I started to feel a mild cold sensation in my lower back. I attributed this potentially to my mild back injury, but it was unclear. The sensory change was intermittent and mild, and ongoing until recently. On 1/9 while at work, I started to feel a mild cold sensation below my belly button, in addition to the intermittent lumbar back cold sensation area. On 1/11 at work, the sensory changes to my lower abdomen and back were more apparent after assisting in a maximal assist transfer with a patient. At this time, it was a combination of cold and burning sensations.
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| 32 | 2021-01-12 | dizziness, fever |
Low grade fever, body aches, lightheadedness and sore arm. Developed a localized rash that was later...
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Low grade fever, body aches, lightheadedness and sore arm. Developed a localized rash that was later diagnosed as shingles on 01/11/2021 by her PCP. A 01/04/202 COVID test was negative.
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| 32 | 2021-01-12 | fever, fatigue | Muscle aches, joint aches, fatigue, fever |
| 32 | 2021-01-12 | dizziness |
Numbness and tingling down left arm into fingers (worst is pinkie and ring fingers), dizziness with ...
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Numbness and tingling down left arm into fingers (worst is pinkie and ring fingers), dizziness with blurred vision, hearing sounded like underwater, felt like I had trouble talking. Notified nurse that gave me vaccine, several other nurses came over and helped me into recliner and laid me back and took vitals. Vitals are stable. I quickly began to feel better (within 5 minutes of being reclined). Still had the numbness and tingling. I laid in recliner for 30 minutes, then sat up for 10 minutes before leaving. I drank water and ate 2 rice krispies while in recliner. Numbness and tingling improved, but lingered throughout the day and was gone next morning.
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| 32 | 2021-01-12 | chills, fever | Patient describes fever and chills and body aches. |
| 32 | 2021-01-12 | throat pain, fatigue, throat irritation |
Pt received Dose 1 of COVID vaccine. Nurse checked on patient five minutes post injection and patien...
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Pt received Dose 1 of COVID vaccine. Nurse checked on patient five minutes post injection and patient reported that she was having some itching at the site. Patient advised would continue to monitor. Slight reddness no raised rash. Checked on patient at 1100, patient asked about soreness of her throat. Patient states that it had just started approx five minutes prior. Patient reports lump sensation in her throat "like something in throat when have cold." PA-C and RN came in for observation and eval. Decided patient to come to urgent care for futher medical eval and observations. Vitals monitored before leaving and WNL (see chart). Patient ambulated per self to urgent care with provider and nurse. At convenient care, pt reports scratchy throat and feels like "something" is in her throat. Denies SOB or cough. Uvula appears slightly swollen, but no previous exams for comparison. Pt given diphenhyramine 25 mg IM x 1 and 15 minutes later she reported mild improvement in swelling, but no change on exam. 45 min after Benadryl she reported feeling tired but improvement in symptoms. Uvula appeared to be smaller on re-examination. Instructed to take 50 mg Benadryl Q 6 hours for the next day. Discharged to home with perscription for albuterol 90 mcg/inh 2 puffs Q6hrs PRN
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| 32 | 2021-01-12 | dizziness, fatigue |
Tired and dizzy within 10min, lasted for 7 hrs until bedtime. The next morning, no longer dizzy but ...
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Tired and dizzy within 10min, lasted for 7 hrs until bedtime. The next morning, no longer dizzy but full body joint pain/ache and injection site pain/ache.
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| 32 | 2021-01-12 | fever, fatigue, headache |
Woke the following morning with 102 fever, severe headache, and fatigue. On Sunday onset lymph node...
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Woke the following morning with 102 fever, severe headache, and fatigue. On Sunday onset lymph nodes under right arm swollen and painful. On Tuesday, 1/12/21 reports improvement of swollen lymph nodes but has continued fatigue.
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| 32 | 2021-01-12 | fatigue, cough | chest tightness and cough up yellow mucus, very fatigued |
| 32 | 2021-01-12 | sweating, chills, weakness, dizziness, fever |
covid injection #1 on 12/23/20. 5 days later on 12/28/2021 woke up with nausea and diarrhea. Had vas...
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covid injection #1 on 12/23/20. 5 days later on 12/28/2021 woke up with nausea and diarrhea. Had vasovagal symptoms of lightheaded, blurred vision, hearing changes, and weakness of legs while standing. was in healthcare setting working at the time. Initial vitals 87/60, drank apple juice and rested, BP came up 15 min later to 100/75. At approx. 7pm on 12/28/2020 developed chills which turned into sweats with myalgia's and arthralgia's, took 1g Tylenol, at 9pm fever still 101.7*F. Fever lasted approx 8 hours. Nausea resolved. Diarrhea lasted about 36 hours.
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| 32 | 2021-01-12 | fatigue, fever, weakness, sweating, migraine |
tachycardia (140 bpm); Fever above 101; myalgia; joint pain right arm, joint pain and swelling to ri...
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tachycardia (140 bpm); Fever above 101; myalgia; joint pain right arm, joint pain and swelling to right wrist; joint pain and swelling to right wrist; swollen lymph node on right side of body; weakness; skin redness and burning sensation; skin redness and burning sensation; tremors; gum pain; fatigue; migraine; sweating; back pain; first dose of bnt162b2 on 18Dec2020 at 16:00, second dose on 04Jan2021 at 08:00 AM; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELU140), via an unspecified route of administration on 04Jan2021 at 08:00 AM on Right arm at single dose for COVID-19 immunization. The patient medical history included had known allergies with Penicillin, bees and wasp. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol, retinol (VITAMIN A); colecalciferol (VITAMIN D); calcium phosphate dibasic, phytomenadione (VITAMIN K); cyanocobalamin (VITAMIN B12); levothyroxine, liothyronine (NP THYROID). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELO140), via an unspecified route of administration on 18Dec2020 at 16:00 on Right arm at single dose for COVID-19 immunization. The patient experienced fever above 101, tachycardia (140 bpm), myalgia, joint pain right arm, joint pain and swelling to right wrist, swollen lymph node on right side of body, weakness, skin redness and burning sensation, tremors, gum pain, migraine, fatigue, sweating and back pain, all on 04Jan2021 at 20:00, events were resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had not been tested for COVID-19. It was unknown if any treatment was received for events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
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| 32 | 2021-01-13 | migraine, night sweats, malaise, fatigue, dizziness |
01/09/21 woke up with Mirgraine, nausea, dizziness with standing and reports inability to eat, flus...
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01/09/21 woke up with Mirgraine, nausea, dizziness with standing and reports inability to eat, flush feeling, night sweats, body aches, tired, fatigue, lymph node tenderness under both arms and arm at injection site was red and swollen about the size of a baseball. Slept most of the day and still did not feel well when woke up later in the day and called into work evening of 01/09/21. Reports when she woke up the morning of 01/10/21 felt great.
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| 32 | 2021-01-13 | headache |
Body aches, Headache. Treatment: Ibuprofen, Outcome: Complete resolution of symptoms after taking Ib...
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Body aches, Headache. Treatment: Ibuprofen, Outcome: Complete resolution of symptoms after taking Ibuprofen
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| 32 | 2021-01-13 | headache | Body aches, Headache; Treatment: Ibuprofen, Outcome: Complete resolution of symptoms |
| 32 | 2021-01-13 | headache, fatigue, chills |
Chills, body aches, headache, and fatigue starting about 12 hours after the vaccine. The chills reso...
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Chills, body aches, headache, and fatigue starting about 12 hours after the vaccine. The chills resolved quickly (within 24 hours), but the headache, body aches, and fatigue have continued through today (one week after receiving the vaccine). Ibuprofen has been the only treatment. The symptoms temporarily improve after taking ibuprofen and then return. I have not been able to exercise since receiving the vaccine and I missed one day of work (1/12/21). I have no history of adverse reactions to any other vaccines and I had no adverse reaction to the first dose. I work as a Clinical Nurse Leader on a Critical Care floor. One of my directors suggested I submit a VAERS.
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| 32 | 2021-01-13 | chills, headache |
Chills; neck/back ache; neck/back ache; headache; This is a spontaneous report from a contactable ph...
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Chills; neck/back ache; neck/back ache; headache; This is a spontaneous report from a contactable pharmacist who reported for herself. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 08Jan2021 at 11:30 (at the age of 32-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none. The patient was not pregnant at the time of vaccination. It was reported that the patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate and zinc oxide (PRENATAL VITAMINS), ascorbic acid (VITAMIN C) and vitamin D3, all taken for unspecified indications from unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Jan2021 at 01:00, the patient experienced chills, neck/back ache and headache. It was reported that the events were non-serious and did not require hospitalization. The patient received treatment for the events which included acetaminophen. The clinical outcomes of the events chills, neck/back ache and headache were recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 32 | 2021-01-13 | headache, respiratory tract congestion, runny nose, fatigue, cold sweat, chills |
Date of symptom onset - ?1/13/21 midday Symptoms - ?EE reports she felt pretty tired of the day aft...
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Date of symptom onset - ?1/13/21 midday Symptoms - ?EE reports she felt pretty tired of the day after receiving her 2nd dose of the vaccine. EE reports when she woke up this am she started feeling generalized body aches, chills, ?clammy? and HA. EE reports + congestion and runny nose. EE denies fever but has been taking Tylenol round the clock since yesterday per EE. Last dose of Tylenol taken at 18:30 (1/13) 1000 mg. At time of call temperature 99.6. EE reports her husband called while at work this am and 7- month old son with cough and fever at home. Last day of work and shift - ?currently at work Home remedies? - see ?symptoms? Any improvement? - mild Recommendation? After completing algorithm with EE, EE meets criteria to be taken off of work and to be scheduled for testing. EE educated to notify manager of need to leave work at this time and to contact EH command center for assistance with testing. EE provided with phone number of EH command center. EE encouraged to continue to monitor symptoms and to contact EH vaccine support line with further questions or concerns. EE verbalized back understanding and denied further questions at this time.
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| 32 | 2021-01-13 | headache |
Employee called the nurse line reported adverse reaction to second covid vaccine. Caller received va...
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Employee called the nurse line reported adverse reaction to second covid vaccine. Caller received vaccine at 1330 and started to have vision changes bilaterally of halos around vision lasting for 10 minutes at a time and a slight headache
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| 32 | 2021-01-13 | chills, dizziness |
Following receiving second dose of COVID-19 vaccine, vaccinated individual had the following reactio...
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Following receiving second dose of COVID-19 vaccine, vaccinated individual had the following reactions 12 hours post-dose: chills, body aches, joint aches. The next morning upon waking to get ready for work, she had nausea and was very light-headed and pale, resulting in a missed day at work.
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| 32 | 2021-01-13 | malaise, headache, fatigue |
For 4 hours post vaccine administration, I experienced the following: Acid reflux flare Fatigue Mild...
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For 4 hours post vaccine administration, I experienced the following: Acid reflux flare Fatigue Mild headache General feeling of being unwell
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| 32 | 2021-01-13 | chills, fatigue, headache, fever | Headache, chills, fever, body aches, shivering, fatigue |
| 32 | 2021-01-13 | dizziness, headache, weakness |
I started feeling weakness, headache and muscle aches on 1/12 the day of 2nd dose of covid vaccine. ...
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I started feeling weakness, headache and muscle aches on 1/12 the day of 2nd dose of covid vaccine. On 1/13 I started feeling dizziness, headache and nausea that lasted until now (1/14).
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| 32 | 2021-01-13 | dizziness, weakness, headache |
On 1/12 I started feeling weak, tired, sore on the injection site. On 1/13 I started feeling dizzy a...
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On 1/12 I started feeling weak, tired, sore on the injection site. On 1/13 I started feeling dizzy and I?m having headache and nausea and I still feel those symptoms now.
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| 32 | 2021-01-13 | headache, chills, fatigue |
PAIN ON INJECTION SITE, HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, SWELLING ON INJECTION SITE, NAUSIA, FE...
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PAIN ON INJECTION SITE, HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, SWELLING ON INJECTION SITE, NAUSIA, FEELING BAD, INCHING ON INJECTION SITE. ONE DAY OF SINTOMES.
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| 32 | 2021-01-13 | headache, fatigue |
PAIN ON INJECTION SITE,HEADACHE ,TIRED MUSCULAR PAIN,CHILLES,SWELLING AREA OF INYECCTION,FEELING BAD...
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PAIN ON INJECTION SITE,HEADACHE ,TIRED MUSCULAR PAIN,CHILLES,SWELLING AREA OF INYECCTION,FEELING BAD, AND INCHING IN INJECITION AREA.
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| 32 | 2021-01-13 | chills |
Soreness at injection site; Soreness radiated down to elbow and thumb/Joint pain; Soreness radiated ...
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Soreness at injection site; Soreness radiated down to elbow and thumb/Joint pain; Soreness radiated down to elbow and thumb; Intense body aches; chills; This is a spontaneous report from a contactable other nurse (patient). A 32-year-old female patient received the first dose of BNT162b2 (Lot number: EK9231), via an unspecified route of administration at right arm on 04Jan2021 13:30 at single dose for covid-19 immunization. Medical history included birth control. Concomitant medication included probiotics, ethinylestradiol, norethisterone acetate (JUNEL) for birth control. The patient experienced soreness at injection site on 04Jan2021 18:00; soreness radiated down to elbow and thumb, Intense body aches, joint pain, chills on 04Jan2021. The patient received the treatment Acetaminophen 1000mg every 6 hours and Ibuprofen 400mg for events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
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| 32 | 2021-01-13 | fatigue |
Supraclavicular lymphadenopathy three days after vaccine. Bilateral upper arm arthralgia six days a...
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Supraclavicular lymphadenopathy three days after vaccine. Bilateral upper arm arthralgia six days after vaccine. Severe fatigue and nausea 16 days after vaccine.
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| 32 | 2021-01-13 | fever, fatigue, headache |
body aches headaches fever of 101.2 fatigue tiredness tachycardia reached 152 leg pain light vaginal...
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body aches headaches fever of 101.2 fatigue tiredness tachycardia reached 152 leg pain light vaginal spotting (not near my expected period dates)
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| 32 | 2021-01-13 | chills, fever |
chills; fever; This is a spontaneous report from a contactable nurse reporting for herself. A 32-yea...
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chills; fever; This is a spontaneous report from a contactable nurse reporting for herself. A 32-years-old female patient started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 07JAN2021 11:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously had BNT162B2 dose 1 for COVID-19 immunization. The patient had been experiencing chills and fever after she received the second dose of the Covid-19 vaccine on 07Jan2021 11:00AM. The symptoms started on 08Jan2021 around 3:00AM, she's still experiencing these symptoms and she took acetaminophen (TYLENOL) to lessen symptoms. Outcome of the events was not recovered. Information on batch/lot number requested.
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| 32 | 2021-01-13 | headache, chills, fatigue, malaise |
injection site pain; tiredness; headache; muscle pain; chills; nausea; feeling unwell; This is a spo...
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injection site pain; tiredness; headache; muscle pain; chills; nausea; feeling unwell; This is a spontaneous report from a contactable pharmacist (patient). This 32--year-old female pharmacist reported for herself received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EK9231/expiration date: unknown), via intramuscular route of administration, on 06Jan2021 at 09:30 AM (at the age of 32 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history was not provided. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN XR) 300mg daily, levothyroxine 25mcg QAM and prenatal vitamin one-a-day. The patient previously received the first dose of BNT162B2 (lot number: EH9899/expiration date: unknown) on 16Dec2020 at 09:30 AM (at the age of 32 years old) as a single dose in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021 at 09:00 PM, after the second dose, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell. Treatment was received for the events injection site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell included Acetaminophen 1000mg Q6Hrs. The outcome of the events injection site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell was unknown. Since the vaccination, the patient had not been tested for COVID-19.
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| 32 | 2021-01-13 | fever, headache |
mild muscle aches; Injection site soreness; feverish; headache; insomnia; restlessness; This is a sp...
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mild muscle aches; Injection site soreness; feverish; headache; insomnia; restlessness; This is a spontaneous report from a contactable Physician reporting for herself. A 32-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231) via an unspecified route of administration, in left arm, on 07Jan2021 at 11:15 at single dose for COVID-19 immunisation. Age at vaccination was 32 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685) was received via an unspecified route of administration on 21Dec2020 at 09:00 in left arm at single dose. Medical history included major depression, and generalised anxiety. The patient had no known allergies to medications, food, or other products. Concomitant medications included escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN) and daily fusion multivitamin. On 08Jan2021 at 01:00 AM the patient experienced injection site soreness, feverish, headache, insomnia, restlessness, mild muscle aches. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The outcome of the events was unknown.
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| 32 | 2021-01-13 | migraine, chills |
~36 hours post-shot woke up in middle of night with migraine, chills and nausea. Took Excedrin, napr...
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~36 hours post-shot woke up in middle of night with migraine, chills and nausea. Took Excedrin, naproxen and Zofran and was able to fall back asleep in about 2 hours.
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| 32 | 2021-01-14 | shortness of breath, dizziness, sweating, headache, fatigue, influenza like illness, chills |
Approx 6 hrs after getting 2nd dose, developed near syncopal episode. Become diaphoretic, heart pal...
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Approx 6 hrs after getting 2nd dose, developed near syncopal episode. Become diaphoretic, heart palpitations, light headed, short of breath. Was placed in a room, had tachycardia with heart rate in the 140's, eventually subsided to normal range over the next 4 hrs. Tuesday had flu like symptoms, headache, body aches, chills, fatigue. Then at night had severe headache ontop of head, to even touch which lasted a few moments and subsided leaving generalized headache. Flu like symptoms persisted through Wed.
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| 32 | 2021-01-14 | dizziness |
At approximately 5 minutes into the 15-minute monitoring window, I became severely dizzy, flush, and...
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At approximately 5 minutes into the 15-minute monitoring window, I became severely dizzy, flush, and light-headed while simultaneously experiencing right-sided tingling, the altered sensation from my forehead to collarbone (right side only). At approximately four hours post-vaccination my right eye had mild blurriness to my vision. The vision resolved within a few hours but the altered right-sided sensations continued for 6 days, gradually improving. The lightheadedness and dizziness that required cool clothes and elevated feet resolved enough to stand after 30 minutes.
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| 32 | 2021-01-14 | fever, malaise, chills |
Began to feel malaise several hours after the second dose of the vaccine. By 12 hours post injectio...
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Began to feel malaise several hours after the second dose of the vaccine. By 12 hours post injection began to feel ongoing malaise, myalgias, and low grade temps (max 100.2 F) with chills. These symptoms lasted for about 24 additional hours and then resolved
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| 32 | 2021-01-14 | throat pain, dizziness, headache, sweating |
Continued dizziness, dry mouth, sore throat, nausea, headache, vertigo, with intermittent sweating a...
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Continued dizziness, dry mouth, sore throat, nausea, headache, vertigo, with intermittent sweating and hot flashes over 48 hrs after vaccination. Improvement with Tylenol 1000mg.
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| 32 | 2021-01-14 | headache | Developed body aches and headache. |
| 32 | 2021-01-14 | fatigue, dizziness | Dizziness, body ache, fatigue, nausea, swelling/redness around injection site. Resolved. |
| 32 | 2021-01-14 | chills, fatigue, headache, malaise |
Fatigue and headache started about 12 hours after vaccine was given, lasted throughout the day on an...
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Fatigue and headache started about 12 hours after vaccine was given, lasted throughout the day on and off, fatigue and malaise progressed throughout the day. Nausea started about 24 hours after vaccination. Then overnight about 30 hours later developed chills and hot flashes alternating through the night, difficulty sleeping, headache and fatigue continued.
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| 32 | 2021-01-14 | fever |
Fever up to 102 F approx 15-25 hours post vaccination.; This is a spontaneous report from a contacta...
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Fever up to 102 F approx 15-25 hours post vaccination.; This is a spontaneous report from a contactable Nurse (the patient). A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Ek9231, expiration date unknown) via an unspecified route of administration on 06Jan2021 at 18:00 (at the age of 32-years-old), at an unspecified dose in the left arm for COVID-19 vaccination. Medical history was reported as "none." The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine at a workplace clinic. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899, expiration date unknown ) via an unspecified route of administration on 16Dec2020 18:00 (at the age of 32-years-old), at an unspecified dose in the left arm for COVID-19 vaccination. Concomitant medication included levonorgestrel (MIRENA). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever up to 102 farenheit approximately fifteen to twenty-five hours post vaccination beginning on 07Jan2021 at 09:00. Treatment information was not provided. The clinical outcome of pyrexia was reported as recovered on an unspecified date in Jan2021. It was also reported that since the vaccination the patient had not been tested for COVID-19.
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| 32 | 2021-01-14 | chills, headache, fever |
Fever@12am 1/14/21 thru 1/15/21 took tylenol Body aches started @8pm 1/13/21 Chills started @12am 1...
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Fever@12am 1/14/21 thru 1/15/21 took tylenol Body aches started @8pm 1/13/21 Chills started @12am 1/14/21 Headache @8pm 1/13/21 thru 1/15/21
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| 32 | 2021-01-14 | fatigue, headache |
Immediate headache and severe nausea, that evening around 12:30am I woke up to my stomach and mouth ...
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Immediate headache and severe nausea, that evening around 12:30am I woke up to my stomach and mouth feeling as if they were on fire. The nausea continued for two days but lightened each day. Very fatigued feeling, pale in color and arms keep falling asleep randomly for 3 days now.
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| 32 | 2021-01-14 | fever, headache |
Myalgia; intense headache; high fever; This is a spontaneous report from a contactable Nurse reporti...
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Myalgia; intense headache; high fever; This is a spontaneous report from a contactable Nurse reporting for herself. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jan2021 (Lot number: EL3248) at single dose (dose number 2, left arm) for COVID-19 immunization. The patient medical history included COVID-19 (Prior to vaccination, patient was diagnosed with COVID-19). The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization, on 19Dec2020 07:30 (Lot number: EJ1685) at single dose (dose number 1, left leg) which was administered intramuscularly at left leg. The patient is not pregnant. No other vaccine was given in four weeks and no other medication was given in two weeks. Patient has no known allergies. Vaccine was administered at hospital. It was unknown if patient tested for COVID-19 after vaccination. Concomitant medications were not reported. The patient experienced Myalgia, intense headache, and high fever on 07Jan2021 17:00. Treatment was not received. Outcome of the events was recovered on an unspecified date in Jan2021. The reporter assessed the events as non-serious.
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| 32 | 2021-01-14 | discomfort |
Neck and shoulder pain; neck and shoulder pain; Not horrible, just uncomfortable; Swollen lymph node...
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Neck and shoulder pain; neck and shoulder pain; Not horrible, just uncomfortable; Swollen lymph node at left collar bone; This is a spontaneous report from a contactable consumer reporting on behalf of a patient. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899, expiration date unknown) via an unspecified route of administration on 07Jan2021 (at the age of 32-years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date unknown) via an unspecified route of administration on 17Dec2020 (at the age of 32 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced neck and shoulder pain on 08Jan2021 which was described as, not horrible, just uncomfortable. The patient also experienced a swollen lymph node at the left collar bone on 08Jan2021. The patient did not receive any treatment for the events. The clinical outcomes of neck and shoulder pain, discomfort and swollen lymph nodes was reported as recovering It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 32 | 2021-01-14 | fever, chills |
Several days after the first dose, I developed shingles and needed medical attention for this. 12 ho...
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Several days after the first dose, I developed shingles and needed medical attention for this. 12 hours after the second dose, I developed fevers, chills, rigors, body aches for 5-6 hours.
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| 32 | 2021-01-14 | dizziness |
Shortly after receiving Dose 1 of Pfizer-BioNTech COVID-19 vaccine, patient reported feeling dizzy a...
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Shortly after receiving Dose 1 of Pfizer-BioNTech COVID-19 vaccine, patient reported feeling dizzy and nauseous. Patient was given water and apple juice. Patient educated on techniques to reduce symptoms/prevent fainting. Patient was then escorted to a room in the facility to lay down and elevate feet. Patient vomited a few times. Patient closely monitored for over 30 minutes by pharmacist and facility staff. Patient symptoms improved and did not require EMS.
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| 32 | 2021-01-14 | shortness of breath, weakness | Shortness of breath, extreme itching, full body flushing, chest pain, weakness. |
| 32 | 2021-01-14 | sweating, fever, chills, fatigue, runny nose, headache |
Signs and symptoms started at 22:30pm which was 13 hours after injection . 22:30pm 1/13/21 - mus...
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Signs and symptoms started at 22:30pm which was 13 hours after injection . 22:30pm 1/13/21 - muscle aches - chills - severe headache - extreme fatigue - runny nose 0600 am 1/14/21 - Nausea - Vomiting - Sweats occurred - Fever 102 with Tylenol - Extreme fatigue 12:00pm on 1/14/21 - Muscle aches - Fatigue - headache - Runny nose - sweats - fever 100.1 Witt ibuprofen 18:00pm 1/14/21 - muscle aches - chills - fever 99.8 with Tylenol - extreme Fatigue - Nausea kicked back in 22:00 pm 1/14/21 - chills - Nausea - body aches - fever 99.6 with Tylenol 05:15am 1/15/21 - woke up in chills - fever 100.2 took some more Tylenol with ibuprofen - muscle aches - headache - fatigue - runny nose 08:00am 1/15/21 - Sweats - fever 99.1 - body aches - Fatigue - Runny nose
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| 32 | 2021-01-14 | headache, fever | headache, diarrhea, fever and joint pain |
| 32 | 2021-01-14 | skin warm, chills |
patient c/o feels like heart racing, denies shortness of breath, HR regular, skin warm and dry, teet...
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patient c/o feels like heart racing, denies shortness of breath, HR regular, skin warm and dry, teeth chattering, patient states they feel cold, monitored for 45 minutes, patient left at 1147 states she is ready to go, states I am ok.
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| 32 | 2021-01-15 | fatigue |
Pregnancy history: early pregnancy, 5 weeks. Symptoms included pain at injection site, mild muscle a...
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Pregnancy history: early pregnancy, 5 weeks. Symptoms included pain at injection site, mild muscle aches, and fatigue. Symptoms starting about 12 hours after shot. 500mg tylenol taken twice.
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| 32 | 2021-01-15 | migraine, chills, sweating, fever |
Severe soreness in left upper arm at location of the shot about 5 hours after the shot, the pain ext...
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Severe soreness in left upper arm at location of the shot about 5 hours after the shot, the pain extended into the armpit/lymph area of my left arm and the pain remained steadily severe until Friday 1/15- 3 days after the initial injection. At 1pm on day of shot (1/12/21) had feelings of chills, sweaty and whole body aches. This lasted until Thursday morning 1/14 around 7am. During that time, took Tylenol for the aches and feverish feelings. Arm soreness finally subsided Friday. migraines started Thursday evening into Saturday morning. With little relief from Imitrex (prescription medication for chronic migraines). Went to the emergency room Saturday for a shot of Torodal for the migraine to subside.
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| 32 | 2021-01-16 | sweating, night sweats, chills, headache, fever, influenza like illness |
12 hours following injection, I developed fever in mid 101 F along with flu-like symptoms of chills,...
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12 hours following injection, I developed fever in mid 101 F along with flu-like symptoms of chills, body aches, headache. 24 hours after injection, I developed swollen and tender lymph node under my left underarm (the same arm that received the shot). 48 hours after injection, I had horrible night sweats needing to change out of drenched pajamas every 1.5 hours.
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| 32 | 2021-01-16 | headache, dizziness |
Burning and itchiness after Injection which went away within an hour. Several hours later I became v...
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Burning and itchiness after Injection which went away within an hour. Several hours later I became very disoriented, dizzy, flush, sevwr headache, diahhrea, nauseous (dry heaving), extremely achy in arm , neck and shoulder. Some symptoms are still present 36/hours later.
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| 32 | 2021-01-16 | shortness of breath, throat swelling |
Felt like throat was swelling after 5 minutes, difficulty breathing after 15 minutes continuing on f...
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Felt like throat was swelling after 5 minutes, difficulty breathing after 15 minutes continuing on for several hours
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| 32 | 2021-01-16 | fever, chills | Fever, rigor, diarrhea, myalgias, lymphadenopathy. |
| 32 | 2021-01-16 | chills, fever, night sweats, headache |
Left cervical painful lymphadenopathy, myalgias, arthralgias, chills, subjective fever, night sweats...
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Left cervical painful lymphadenopathy, myalgias, arthralgias, chills, subjective fever, night sweats, headache from afternoon day of vaccine lasting for 18 hours.
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| 32 | 2021-01-16 | throat irritation, headache |
Metallic taste in mouth that started about five minutes post vaccination; persisted for about two ho...
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Metallic taste in mouth that started about five minutes post vaccination; persisted for about two hours post vaccination. Facial and hand swelling started two hours post vaccination, persisted for 24 hours after; itchy throat started at two hours after, persisted for about eight hours after vaccination. 18 hours post vaccination, severe headache and moderate nausea set in, both lasted for another 18 hours (36 hours post vaccination). Mild myalgias and nausea at 48 hours pat vaccination.
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| 32 | 2021-01-17 | chills, fatigue, headache, fever |
On 1/15 developed Fatigue, headache, fever, chills and body aches. Employee health swabbed her by ...
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On 1/15 developed Fatigue, headache, fever, chills and body aches. Employee health swabbed her by PCR and test was Positive for Covid. On 1/16 had no symptoms and was retested by PCR and was Negative.
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| 32 | 2021-01-17 | fatigue |
tachycardia, arm pain, erythema, swelling; facial flushing/burning; fatigue, rash On 1-14-21 she tes...
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tachycardia, arm pain, erythema, swelling; facial flushing/burning; fatigue, rash On 1-14-21 she tested +for Covid
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| 32 | 2021-01-18 | chills, fever, headache, fatigue, shortness of breath |
Around 9 pm, my arm became more sore and started radiating into my shoulder and I had chills. I had...
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Around 9 pm, my arm became more sore and started radiating into my shoulder and I had chills. I had a low-grade fever and I had slight SOB. Not sure if it was due to vaccine or the fact that I'm big and pregnant. The next more I was extremely sore all over. I also experienced major fatigue and a headache. I just rested and felt better afterwards and it went away.
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| 32 | 2021-01-19 | fatigue |
Fatigue; pretty severe muscle aches; This is a spontaneous report from Non-contactable consumer (pat...
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Fatigue; pretty severe muscle aches; This is a spontaneous report from Non-contactable consumer (patient) via. A 32-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, lot # EL1284) intramuscular at single dose on 06Jan2021 for Covid-19 immunisation. Medical history included drug hypersensitivity. The patient has not suffered from Covid prior vaccination. The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient experienced fatigue and pretty severe muscle aches on 07Jan2021. No treatment received. The outcome of recovered in Jan2021. Post-vaccination COVID tests were not performed. No follow up attempts are possible. No further information is expected.
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| 32 | 2021-01-19 | fever, fatigue, headache |
High fever every 3 hours; I got a rash; Vomiting; Very Bad Headache; Joint pain; Fatigue; Pain in In...
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High fever every 3 hours; I got a rash; Vomiting; Very Bad Headache; Joint pain; Fatigue; Pain in Injection site; Lymph nodes swelling and pain; Lymph nodes swilling and pain; received the first dose on 18Dec2020 and the second dose on 06Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3746), via an unspecified route of administration on the left arm on 06Jan2021 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient has no known allergies. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on the left arm on 18Dec2020 at 07:30 at a single dose as COVID-19 immunization. The patient had no other vaccine in four weeks, no COVID prior vaccination, and did not test post-vaccination. The patient had a rash, high fever every 3 hours, vomiting, very bad headache, joint pain, fatigue, pain in injection side, lymph nodes swelling and pain on 08Jan2021 at 12:00. No treatment was administered for the events. The events were resolving.
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| 32 | 2021-01-19 | headache, fever, fatigue, chills |
I had the typical reactions: fever, headache, chills, fatigue but then got cellulitis right below in...
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I had the typical reactions: fever, headache, chills, fatigue but then got cellulitis right below injection site.
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| 32 | 2021-01-19 | dizziness, headache, fever | Light headed Fever Body aches Headache Stomach ache Nausea |
| 32 | 2021-01-19 | chills, headache |
Patient awoke in the middle of the night shaking (chills), but was not running a fever. After taking...
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Patient awoke in the middle of the night shaking (chills), but was not running a fever. After taking 1000 mg of acetaminophen the shaking resolved in 30 minutes. That same day around 10 AM patient had muscle soreness in neck and shoulders and a mild headache.
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| 32 | 2021-01-19 | shortness of breath |
Patient reports that she did not have any issues after the first Covid19 Pfizer vaccine but 5 minute...
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Patient reports that she did not have any issues after the first Covid19 Pfizer vaccine but 5 minute after her second dose she felt like it was hard to swallow. She attributed this to excitement from completing vaccine series and finished her 15 minute wait time. She went home but it became harder to swallow and she felt like her chest was "heavy" and she became short of breathe walking up stairs. She took fexofenadine 180mg and cetirizine 10mg and filed a report with the CDC. Her symptoms resolved and she slept. The morning after her vaccine she felt fine and went for a 6 mile run. She called vaccine clinic to see what kind of follow up she needed to completed and was asked to contact PCP and employee health. She presented to PCP that day (day after second vaccine) who reported ongoing symptoms of moderate chest tightness and some throat discomfort. Given prescription for Medrol dose pack, albuterol inhaler, and EpiPen and instructions on when to present for care.
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| 32 | 2021-01-19 | headache, body temperature increased, fatigue |
Temp 100.4F, headache, muscle aches, bony aching, nausea, reduced appetite, fatigue. All resolved af...
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Temp 100.4F, headache, muscle aches, bony aching, nausea, reduced appetite, fatigue. All resolved after 1 day except fatigue resolved after 2 days
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| 32 | 2021-01-19 | chills, fever |
Vaccine given on Friday 1/8 at 10am. Started having significant fevers, chills, myalgias, rigors on ...
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Vaccine given on Friday 1/8 at 10am. Started having significant fevers, chills, myalgias, rigors on 1/9 around 1pm. Symptoms lasted for about 8hrs. On 1/10 developed left upper arm, axillary, chest wall, and clavicular soft tissue swelling with significant lymphadenopathy. Lymphadenopathy was tender, multiple nodes ~2cm. Started experiencing severe sharp shooting pain and burning in similar region. On 1/11 started developing weakness in L arm and hand, with numbness in left hand. Went to urgent care on 1/11. Exam demonstrated 4/5 strength of left arm and hand. Started prednisone 40mg on 1/11. Swelling, pain, and weakness persisted. Seen in ER 1/15, exam with persistent weakness and lymphadenopathy. MRI brachial plexus performed which showed multiple enlarged nodes adjacent to brachial plexus. No overt inflammation or compression of brachial plexus. Received IV dexamethasone, and PO prednisone course. Finished 10d of prednisone 40mg with improvement in soft tissue edema, but still with residual weakness and pain. EMG pending. Diagnosed with brachial plexopathy secondary to compressive adenopathy from COVID 19 vaccine.
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| 32 | 2021-01-19 | fatigue, headache |
Woke up the next morning with fatigue, body/muscle aches, and headache. Took Tylenol. Symptoms gone ...
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Woke up the next morning with fatigue, body/muscle aches, and headache. Took Tylenol. Symptoms gone the following morning. Symptoms started 12-16 hours after dose and lasted 24 hours.
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| 32 | 2021-01-19 | chills, fever, sweating, lethargy |
chills, sweating, severe body aches (comparable to birth contractions), joint pains, lethargy. start...
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chills, sweating, severe body aches (comparable to birth contractions), joint pains, lethargy. started at 12:30 am 1/19/21 until 3:00pm that day. Then just the body aches continued with a low grade temp of a 100 until 10:30 pm that night.
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| 32 | 2021-01-19 | chills, fatigue, fever |
chills; muscle aches; fatigue; a fever of 103 F; currently breastfeeding mother received the vaccine...
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chills; muscle aches; fatigue; a fever of 103 F; currently breastfeeding mother received the vaccine; currently breastfeeding mother received the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported information for both mother and baby. This is the maternal case. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3246), via an unspecified route of administration in the right arm, on 08Jan2021 at 05:45 (at the age of 32-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension, non-ongoing COVID-19 from Apr2020 to an unspecified date (1.5 weeks with symptoms at 28 weeks pregnant; recovered), and breastfeeding from an unspecified date and ongoing. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included labetalol (MANUFACTURER UNKNOWN) and an unspecified postnatal vitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced chills, muscle aches, fatigue, and a fever of 103 F on 08Jan2021 at 19:00. The events were reported as non-serious. The currently breastfeeding mother received the vaccine on 08Jan2021 at 05:45. The clinical course was reported as follows: Approximately 12 hours (as reported) after the vaccine, the patient developed chills, muscle aches, fatigue, and a fever and body temperature of 103 F on 08Jan2021 at 19:00. The patient was treated with an unspecified antipyretic and the fever and body temperature spiked to 103 F again during the night. The next day (24-48 hours post vaccine), the patient had a fever and body temperature of 100-101.7 F on 09Jan2021, intermittently while treating with ibuprofen (MANUFACTURER UNKNOWN). The chills were not as bad as before, but body aches and fatigue were still present. On 10Jan2021, over 48 hours post-vaccine, the patient felt mostly fatigued with body temperature of 99 F. At 13:00 on 10Jan2021, the fever came back at body temperature of 101.6 F, which was treated with ibuprofen. Therapeutic measures were taken as a result of chills, muscle aches, fatigue, and a fever of 103 F as aforementioned. The clinical outcome of chills, muscle aches, fatigue, and a fever of 103 F was recovering and of currently breastfeeding mother received the vaccine was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021022120 same reporter, different patient/event (baby case)
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| 32 | 2021-01-19 | dizziness, fever, headache, fatigue, chills |
interrupt sleep throughout the night; mild body aches; lightheadedness; fatigue; slight headache; in...
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interrupt sleep throughout the night; mild body aches; lightheadedness; fatigue; slight headache; injection site soreness; Chills; fever; This is a spontaneous report from a contactable pharmacist (patient) and a contactable other health professional. A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), on 17Dec2020 at 14:30 and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 08Jan2021 at 12:30, each via an unspecified route of administration at right arm at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medication included bupropion XL at 150 mg. On an unspecified date, the patient experienced 12 hrs. after vaccine administration, chills and subjective fever began and lasted approximately 24 hrs. (until 36 hrs. post-vaccine) severe enough to interrupt sleep throughout the night. Mild body aches during this time, along with lightheadedness, fatigue, slight headache and injection site soreness. The patient didn't receive any treatment. The patient outcome of the events was recovered.
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| 32 | 2021-01-19 | throat irritation | itchy throat, lump in throat, itchy mouth, trouble swallowing |
| 32 | 2021-01-19 | throat irritation |
patient reported feeling itchiness in throat. Denied shortness of breath, trouble breathing, throa...
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patient reported feeling itchiness in throat. Denied shortness of breath, trouble breathing, throat constriction. No rash forming. BP 156/104 HR79 Patient was provided water, loosened constrictive clothing, rested comfortably for 30 minutes. Symptoms improved. Patient verbalized she felt ok to go home and take a Benadryl.
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| 32 | 2021-01-20 | dizziness |
Mild myalgias 36h after on 19Dec2020 02:30; Intermittent mild Dizziness and nausea 24h after vaccine...
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Mild myalgias 36h after on 19Dec2020 02:30; Intermittent mild Dizziness and nausea 24h after vaccine; Intermittent mild Dizziness and nausea 24h after vaccine; Pain at side of puncture, unable to lift arm from 12h to 40 hours after; unable to lift arm from 12h to 40 hours after; This is a spontaneous report from a contactable Physician(patient). A 32-year-old female patient received first dose BNT162B2 (lot number EH9899) , via an unspecified route of administration at Arm Right on 17Dec2020 14:30 at the 32 years old at single dose for COVID-19 immunization. The medical history was not reported. The concomitant medication was levothyroxine. The patient experienced Pain at side of puncture on 18Dec2020 12:00, unable to lift arm from 12h on 18Dec2020 02:30 to 40 hours after on 20Dec2020 06:30, Intermittent mild Dizziness and nausea 24h after vaccine on 18Dec2020 14:30, Mild myalgias 36h after on 19Dec2020 02:30, resolved at 48h post vaccine on 19Dec2020 14:30. There was no treatment received for all the adverse events. There was no other vaccine in four weeks. The outcome of the events was Recovered.
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| 32 | 2021-01-21 | chills |
About 12 hours after the dose, I experience severe body aches (especially back and knees), chills an...
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About 12 hours after the dose, I experience severe body aches (especially back and knees), chills and nausea. About 24 hours later, the symptoms improved with use of ibuprofen and acetaminophen.
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| 32 | 2021-01-21 | chills, headache, body temperature increased |
Approximately 12-14 hours after vaccination got chills, temperature up to 99.5-100 and severe headac...
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Approximately 12-14 hours after vaccination got chills, temperature up to 99.5-100 and severe headache the next morning.
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| 32 | 2021-01-21 | fever, chills | DAVELOPED BODY ACHES, FEVER, AND CHILLES THAT LASTED UNTIL 1/21/21 @6AM. |
| 32 | 2021-01-21 | fever, chills | FEVER, CHILLS, BODY PAIN |
| 32 | 2021-01-21 | shortness of breath | Flushing and shortness of breath immediately after receiving vaccine Lasted approx 5 minutes |
| 32 | 2021-01-21 | headache |
Muscle soreness, severe headache the morning after vaccine about 11 hours after. Joint/muscle aches ...
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Muscle soreness, severe headache the morning after vaccine about 11 hours after. Joint/muscle aches began about 5 hours later. Started noticing left a Dillard pain not long after that. Very enlarged left ancillary lymph node noticed around 6pm. Painful with and without touch. Visibly enlarged. Feels about baseball size. Slight enlargement in right axilla but no associated pain or discomfort. Still present next day
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| 32 | 2021-01-21 | dizziness |
Pt entered observation @ 09:42 AM. At 09:52 AM, patient came up and stated that she felt "light-head...
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Pt entered observation @ 09:42 AM. At 09:52 AM, patient came up and stated that she felt "light-headed", and that her HR was 150. This nurse explained to patient that she needed to sit back down r/t the "light-headedness". Asked patient if she would like some water patient stated "no, she was ok". At 09:56 AM, the nurse noticed "red blotches" to neck of patient. This nurse walked patient to bed in observation room. Denies SOB nor troubled breathing. Benadryl 25mg was given PO @ 09:56 AM. V/S obtained @ 10:02 AM. BP-120/80, P-124, R-18, O2-99. Still voices no s/s of SOB nor troubled breathing. States to this nurse that she had an "anaphylactic reaction" to lobster years ago, in which she did not state this upon receiving the vaccinations. Also has allergies to Zofran and Macrolides. Pt remains in observation @ present time @ 10:06 AM. Redness remains to neck and upper BL arms. Remains in observation @ 10:30 AM. S/S somewhat alleviated, no lightheadness, but does voice nausea. Stated that she only at a "Granola Bar" this morning. HR remains between 97-114. V/S taken @ 10:39 AM BP-118/76, P-98, R-18, 02-99. Remains in observation @ present time. Time is 10:47 AM. S/S of feeling better @ 10:52 AM, remains in observation. Will call an Uber home, will remain in observation until Uber arrives. Denies SOB nor troubled breathing.
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| 32 | 2021-01-21 | malaise, headache, fatigue |
Started with a headache which ended up lasting for >48 hrs. Treated w/alternating tylenol and ibupro...
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Started with a headache which ended up lasting for >48 hrs. Treated w/alternating tylenol and ibuprofen. Then came intense fatigue and malaise w/body and muscle aches. Lastly, swollen lymph nodes in armpit on arm of injection site and arm pain.
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| 32 | 2021-01-24 | weakness, headache, chills, body temperature increased | Chills, headache, Fever upto 102.2 degree F, generalized weakness and body ache. |
| 32 | 2021-01-24 | fatigue, chills, headache |
Rashes and itching of the skin by breast, stomach, arms and hands. Headaches, chills, Body aches and...
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Rashes and itching of the skin by breast, stomach, arms and hands. Headaches, chills, Body aches and fatigue.
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| 32 | 2021-01-24 | migraine |
Terrible migraine about an hour after my first injection lasting through the night. After 24 hours, ...
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Terrible migraine about an hour after my first injection lasting through the night. After 24 hours, no headache.
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| 32 | 2021-01-24 | fatigue, headache, malaise, fever | fever of 99.6 fahrenheit, moderate headache, fatigue, malaise |
| 32 | 2021-01-25 | fever, chills |
Arm swelling with itchiness; Arm swelling with itchiness; warm to touch at site of injection; severe...
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Arm swelling with itchiness; Arm swelling with itchiness; warm to touch at site of injection; severe chills with shaking; severe chills with shaking; 103 fever/ approx 20hrs after injection, fever of 100 or greater for 24hrs with minimal relief with Tylenol; body aches; pains in left flank; the first dose on 20Dec2020/second dose on 12Jan2021; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 32-year-old female patient (not pregnant) received the second dose of bnt162b2 via an unspecified route of administration on 12Jan2021 10:30 AM at single dose in Left arm for COVID-19 immunisation. Medical history included cardiogenic syncope, no COVID prior vaccination. Concomitant medications included birth control drugs, no other vaccine in four weeks. The patient previously received the first dose of bnt162b2 on 20Dec2020 03:00PM on Left arm for COVID-19 immunization, topiramate (TOPAMAX) and experienced drug allergy, morphine and experienced drug allergy (hives). The patient experienced arm swelling with itchiness and warm to touch at site of injection, severe chills with shaking, 103 fever, approx. 20 hours after injection, fever of 100 or greater for 24 hours with minimal relief with Tylenol, body aches and pains in left flank. The adverse events started from 12Jan2021, 06:00 PM. Therapeutic measures taken for fever included Tylenol, no treatment was received for other events. The outcome of the events was recovering. The patient didn't test COVID post vaccination. Information on the lot/batch number has been requested.
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| 32 | 2021-01-25 | headache, fever | Fever, body aches, headache, n/v/d |
| 32 | 2021-01-25 | fever, fatigue, headache |
Feverish, painful joints, headache, fatigue 12 hours after injection lasting until 48 hours after in...
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Feverish, painful joints, headache, fatigue 12 hours after injection lasting until 48 hours after injection
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| 32 | 2021-01-25 | sweating, fatigue, headache, chills |
Severe headache; severe body aches; severe joint aches; chills; sweats; fatigue; loss of appetite; T...
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Severe headache; severe body aches; severe joint aches; chills; sweats; fatigue; loss of appetite; This is a spontaneous report from a contactable pharmacist (patient). This 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EJ1686), via an unspecified route of administration on 11Jan2021 17:30 at single dose on the left arm for COVID-19 immunization. The patient's medical history included depression and gastrooesophageal reflux disease (GERD). No known allergies. The patient's concomitant medications included bupropion, famotidine and birth control medication received in two weeks. The patient previously took the first dose of BNT162B2 (Lot number=Ej1685) on 23Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. No other vaccine received in four weeks. Facility type vaccine was workplace clinic. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient experienced severe headache, severe body aches, severe joint aches, chills, sweats, fatigue, loss of appetite on 12Jan2021. No treatment received. Outcome of the events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.
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| 32 | 2021-01-25 | nasopharyngitis, runny nose, headache |
This is a spontaneous report from a contactable other health professional (patient herself). A 32-y...
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This is a spontaneous report from a contactable other health professional (patient herself). A 32-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# El1284), via an unspecified route of administration on 30Dec2020 11:45 in right arm at single dose for COVID-19 immunization. Medical history included COVID from 15May2020 to an unknown end date. Known allergies was no. Other medications in two weeks included pantoprazole, cholecalciferol (VIT D3), ascorbic acid (VIT C), zinc, fish oil, curcuma longa (TURMERIC). The patient experienced mild cold like symptoms (runny nose and sore chest) 3 days after vaccine on 02Jan2021, blood spots on right abdomen, chest 3-4 days after vaccine in Jan2021. Constant headache for a week starting 5 days after vaccine on 04Jan2021 and elevated blood pressure, racing heart, and chest pain 5 days after vaccine on 04Jan2021. All events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included COVID positive on 15May2020. The patient had COVID test of nasal swab post vaccination and result with negative. Outcome of events were unknown. No treatment was received for events.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported bleeding cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 32 | 2021-01-25 | fever |
fever to 102.8; This is a spontaneous report from a contactable (patient). This 32-year-old female ...
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fever to 102.8; This is a spontaneous report from a contactable (patient). This 32-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 18Dec2020 at single dose for COVID-19 immunisation. The patient was vaccinated at Pharmacy or Drug Store. Age at vaccination was 32-years-old. No other vaccine was received in four weeks. Medical history and concomitant medications were unknown. About 20 hours after the first vaccine (Dec2020), the patient ran a fever to 102.8, lasted about 12 hours. Information on the Lot/Batch number has been requested.
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| 32 | 2021-01-26 | fatigue, chills | Chills w/ uncontrollable shivering, body aches, exhaustion |
| 32 | 2021-01-26 | headache |
Employee received her 2nd COVID-19 vaccine on Friday, January 22. On day 3 of her vaccination she d...
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Employee received her 2nd COVID-19 vaccine on Friday, January 22. On day 3 of her vaccination she developed neck pain that decreased her ability to turn her head from side to side or look up/down. She has taken Ibuprofen and one of her husband?s baclofen for relief, and she states that it did not touch the pain, rating it a 5/10. She has not had any changes in sensation to any of her other extremities, and this pain does not radiate anywhere. She does state that she does also have a slight headache, but no sensitivity to light.
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| 32 | 2021-01-26 | headache, fever, chills, fever, chills, headache | Fever body aches, chills, nausea, headache |
| 32 | 2021-01-26 | chills, fever, night sweats, headache, fatigue |
Fever; Chills; Body aches; Fatigue; Headaches; Night sweats; This is a spontaneous report from a con...
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Fever; Chills; Body aches; Fatigue; Headaches; Night sweats; This is a spontaneous report from a contactable nurse(patient). A 32-years-old female patient received second dose BNT162B2( lot number Eh9899), Intramuscular at Arm Left on 12Jan2021 11:00 at 32 years old at single dose for COVID-19 immunization. The medical history included Penicillin allergy. The concomitant medication was propranolol. The patient previously took Clindamycin and experienced drug allergy. The Historical Vaccine was first doe BNT162B2 on 23Dec2020 09:00 at 32 years old for COVID-19 immunization. On 12Jan2021 21:30 the patient experienced Fever, chills, body aches, fatigue, headaches, night sweats. All the events resulted in Physician Office Visit. There was no treatment received for all the events. There was no other vaccine in four weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of the events was recovering.
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| 32 | 2021-01-26 | headache, fever, fatigue | Low grade fever Joint aches Headaches Fatigue |
| 32 | 2021-01-26 | fever, fatigue, headache |
Within a few hours, I became flushed but no fever. Then later in the evening, symptoms include heada...
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Within a few hours, I became flushed but no fever. Then later in the evening, symptoms include headache, body ache, fever of 101, aches in my bones and fatigue.
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| 32 | 2021-01-27 | fatigue |
hot and cold chills; body aches; tired; nausea; did not sleep the rest of the night; This is a spont...
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hot and cold chills; body aches; tired; nausea; did not sleep the rest of the night; This is a spontaneous report from a contactable consumer. A 32-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL0142, via an unspecified route of administration in the left arm on 12Jan2021 10:30 at a SINGLE DOSE for covid-19 immunization. Medical history included Gluten and dairy allergy. Prior vaccination, patient has had covid-19 from an unknown date to 30Dec2020. Patient was not pregnant during vaccination. Concomitant medications included curcumin, acetylcysteine, ascorbic acid, quercetin, vitamin b complex, vitamin c and colecalciferol. The patient previously took minocycline and zithromax and experienced allergy to both. The patient received the vaccine on 12Jan2021 at 10:30 and started feeling symptoms hot and cold chills, body aches on 13Jan2021 around 1:00 AM. She did not sleep the rest of the night and throughout the day was tired, chills, body aches, nausea. Patient also stated that she started her period the day she received the vaccine which she was not sure if did help her immune system. The outcome of events was recovering. Patient did not received any treatment due to the events. Since the vaccination, the patient hasn't been tested for COVID-19. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 32 | 2021-01-28 | migraine, fever, chills, cold sweat, headache, sweating |
24 weeks pregnant at time of 2nd shot. Shot given at 1430 on 1/27 in left deltoid. Felt great rest o...
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24 weeks pregnant at time of 2nd shot. Shot given at 1430 on 1/27 in left deltoid. Felt great rest of day. @0500 on 1/28 woke up shivering uncontrollably. Mild fever of 100.5(highest recorded during this whole episode). Body aches, chills, sweats, headache rest of day. 1000 mg Tylenol helped with fever/chills but headache progressed to migraine w/nausea. Took 50 mg sumatriptan and 25 mg doxylamine in evening and this seemed to help with headache and allow me to get to sleep 1/28. Woke up at 0300 1/29 with chills/cold sweats. Took 1000 mg Tylenol again (didn't check temp) and went back to sleep. Woke up at 0530 for work - checked temp since I'm a healthcare worker and it was 100.4 (with tylenol). Waited until clinic opened up and called them at 0700 for recommendations on going to work or not (temp by then was 99.8, with tylenol). Was advised to stay home and if febrile tomorrow to get COVID tested on 1/30. As of right now (1300 on 1/29) headache has returned but mild. Body aches still. Temp 99.4 w/tylenol redosed at 1000.
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| 32 | 2021-01-28 | fatigue, sweating, headache, chills |
Arm very sore ~12 hours after injection. Chills, hot sweats, body aches, and headache through the ni...
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Arm very sore ~12 hours after injection. Chills, hot sweats, body aches, and headache through the night unable to sleep due to side effects. Day after vaccine achy and tired. 2 days after vaccine feel back to normal.
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| 32 | 2021-01-28 | shortness of breath | Had 2nd vaccine on Wednesday, today she has shortness of breath and chest pain |
| 32 | 2021-01-28 | headache, fatigue, chills | Headache, body aches, fatigue, chills, and temp. |
| 32 | 2021-01-28 | dizziness |
Immediate hematoma at injection site, normal injection soreness, no itching, no redness. 10 minutes ...
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Immediate hematoma at injection site, normal injection soreness, no itching, no redness. 10 minutes later felt dizziness and light headedness but it only lasted 5 minutes. 20 minutes later pt still has a small bleb at injection site.
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| 32 | 2021-01-28 | shortness of breath | Multiple Seizures 24 hrs after event unable to breathe lasted for over one week. |
| 32 | 2021-01-28 | cough, nasal congestion, throat pain |
Report of body aches, cough, congestion and sore throat. No home remedies. Outcome: referred for te...
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Report of body aches, cough, congestion and sore throat. No home remedies. Outcome: referred for testing.
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| 32 | 2021-01-28 | headache, migraine |
Severe Headache/Migraine lasting for over 2 weeks; Severe Headache/Migraine lasting for over 2 weeks...
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Severe Headache/Migraine lasting for over 2 weeks; Severe Headache/Migraine lasting for over 2 weeks; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 30Dec2020 10:00 at a single dose on left arm for COVID-19 immunization. Medical history included spinal stenosis and allergies to cephalosporin. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included gabapentin. On 30Dec2020 19:00, the patient experienced severe headache/migraine which lasted for over 2 weeks, required prescription medication to make them bearable but even then, they didn't go away and were very bad. The patient spent the good part of two weeks in bed or at least not doing her regular level of activity. She went to Urgent Care twice and to the Emergency Room once. The patient was given prescription medication and IV pain medication as treatment for the events. The patient underwent lab tests and procedures which included nasal swab test (COVID-19 virus test) on 11Jan2021: negative result; and the same test on 14Jan2021 with negative result. The patient was recovering from the events. Information on the lot/batch number has been requested.
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| 32 | 2021-01-28 | cough |
severe cough; left nostril swelling; generalized hives throughout abdomen and hips; lower lip swolle...
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severe cough; left nostril swelling; generalized hives throughout abdomen and hips; lower lip swollen/upper lip on left side swelling; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 07Jan2021 at 13:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history included allergies to dust, pollen, and dog and cat dander. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on 17Dec2020 at 13:00 on the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 12Jan2021 at 21:00 (five days after second vaccine dose, for clarification), the patient had lower lip swollen. Second episode occurred (on an unspecified date) with severe cough, upper lip on left side swelling, left nostril swelling, and generalized hives throughout abdomen and hips. The patient took Benadryl for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering. Information about lot/batch number has been requested.
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| 32 | 2021-02-02 | fatigue |
Pt +covid test 14Jan2021; Pt +covid test 14Jan2021; Tachycardia; Facial flushing; Fatigue; arm pain ...
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Pt +covid test 14Jan2021; Pt +covid test 14Jan2021; Tachycardia; Facial flushing; Fatigue; arm pain and swelling; arm pain and swelling; This is a spontaneous report from a contactable Other HCP. A 32-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 12Jan2021 at single dose for COVID-19 immunisation, administered at hospital. Relevant medical history included attention deficit hyperactivity disorder (ADD), hypothyroidism and anxiety. Past drug history included allergy to cefprozil (CEFZIL). Relevant concomitant medications included bupropion hydrochloride (WELLBUTRIN XL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and levothyroxine sodium (SYNTHROID). On 12Jan2021, the patient had tachycardia, facial flushing, fatigue, arm pain and swelling. The events required a physician office visit. Therapeutic measures taken as result of the events included levocetirizine dihydrochloride (XYZAL) and diphenhydramine hydrochloride (BENADRYL). On 14Jan2021, the patient underwent a COVID-19 virus test (nasal swab) which resulted positive. The outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 12Jan2021, and COVID-19 test positive on 14Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.
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| 32 | 2021-02-03 | headache, fatigue, chills, fever |
cellulitis in right arm below injection site; fever; headache; chills; fatigue; This is a spontaneou...
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cellulitis in right arm below injection site; fever; headache; chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 11Jan2021 at 07:45 AM at a single dose for COVID-19 immunization in a hospital. Medical history reported as none. The patient has no known allergies. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration) on 23Dec2020 at 07:45 AM in left arm for COVID-19 immunization. Concomitant medications included dicyclomine; and unspecified birth control and multivitamin. The patient experienced fever, headache, chills, fatigue, and then got cellulitis in right arm below injection site following second dose of COVID vaccine on 14Jan2021 at 12:00 PM. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient received antibiotics (Keflex) as treatment for the events. The patient recovered from the events in Jan2021. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Vaccination site cellulitis cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 32 | 2021-02-07 | chills, headache, head discomfort, discomfort |
Delirium; headache; body chills; nausea; strong pressure felt in head and neck; strong pressure felt...
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Delirium; headache; body chills; nausea; strong pressure felt in head and neck; strong pressure felt in head and neck; blurred vision; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9261, expiry date not reported) via an unspecified route of administration at left arm, on 22Jan2021 10:45, single dose, for COVID-19 immunization. Medical history included neoplasm malignant and hypersensitivity. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccine in the last four weeks. It was unknown if the patient has COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medication included alprazolam (XANAX) and doxycycline hyclate. On 22Jan2021 14:00, the patient experienced delirium, headache, body chills, nausea, strong pressure felt in head and neck, and blurred vision. Outcome of the events was not recovered.
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| 32 | 2021-02-21 | fatigue | Injection site pain, body aches, fatigue |
| 32 | 2021-02-21 | dizziness, cold sweat |
Lightheaded. Skin was clammy, convulsions started, Epi pen administered, she had tongue swelling, ca...
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Lightheaded. Skin was clammy, convulsions started, Epi pen administered, she had tongue swelling, came around then eyes rolled back in head, nausea, blood pressure high.
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| 32 | 2021-02-21 | shortness of breath, chills, migraine, fatigue |
Migraine headache, exhaustion, pain at injection site, shortness of breath, body aches, chills. Took...
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Migraine headache, exhaustion, pain at injection site, shortness of breath, body aches, chills. Took ibuprofen at onset of symptoms, headache subsided but the rest lingered for another 24 hours.
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| 32 | 2021-02-22 | shortness of breath |
1/7 vaccination Within a couple minutes after vaccination, my tongue started to tingle. like pop roc...
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1/7 vaccination Within a couple minutes after vaccination, my tongue started to tingle. like pop rocks in mouth. I got extremely nauseous. Within 5 minutes, everything was spinning. Continued progressing. HR 180. Within 10 min, i was in ER. They gave my epi pen but it didn't work right away. They were about to start an epi pen and to knock me out, they gave me Benadryl IV, Pepcid?, and they were 30 seconds from intubating me. My vocal cords; broncho spasms. I slowly started to get better. They monitored me for 7 hours. *Still experiencing, daily, SOB. My voice gets harsh. I run out of breath walking, talking, etc. I use prednisone, 2 inhalers daily; Advere and Rescue inhaler. I also suffer from EXTREME HA since then and am on 2 medications for the HA.
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| 32 | 2021-02-22 | influenza like illness |
12/17 vaccination 12/18 within 24 hours, arm was hurting. Immense pain to arm. Flu like symptoms. To...
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12/17 vaccination 12/18 within 24 hours, arm was hurting. Immense pain to arm. Flu like symptoms. Took Motrin. Symptoms lasted for 3 days.
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| 32 | 2021-02-22 | headache, fever | Body aches, fever, headache |
| 32 | 2021-02-22 | throat irritation |
Itchiness in tongue and throat. Benadril 25 mg Po/ solumedrol 125mg IV Home: Medrol 4mg PO/ Atorax 2...
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Itchiness in tongue and throat. Benadril 25 mg Po/ solumedrol 125mg IV Home: Medrol 4mg PO/ Atorax 25mg.
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| 32 | 2021-02-22 | headache, fatigue | Tenderness on the injection site left arm, Right hip pain, Right elbow pain, Headache and fatigue |
| 32 | 2021-02-23 | shortness of breath, throat pain, chills, throat irritation, headache, fatigue, malaise |
Monday-second day after=started to feel more sick, scratchy/sore throat; scratchy/sore throat; Monda...
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Monday-second day after=started to feel more sick, scratchy/sore throat; scratchy/sore throat; Monday-second day after=started to feel more sick, scratchy/sore throat/scratchy throat; Chest heaviness/tightness-slightly short of breath/chest tightness; Chest heaviness/tightness-slightly short of breath; Muscle aches; Minor chills; Headache; Sunday-first day after=just felt lousy, fatigue/fatigue; General malaise/ just felt lousy; Saturday night= extremely sore arm (lasted for first 24-48 hrs after); This is a spontaneous report from a contactable nurse. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1284), intramuscular on the left arm at the age of 32 years, on 23Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included eczema and allergy to metals from an unknown date and unknown if ongoing. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient received the first dose on 02Jan2021. On Saturday night (23Jan2021), the patient's had extremely sore arm (lasted for first 24-48 hrs. Then on Sunday( 24Jan2021), patient just felt lousy and fatigue. On Monday (25Jan2021), patient started to feel more sick, scratchy/sore throat, fatigue, chest heaviness/tightness lightly short of breath, muscle aches, minor chills, headache. On Tuesday, third day after, muscle aches, headache, fatigue, general malaise, scratchy throat, chest tightness. No treatment was received for the events. The outcome of the events was recovering.
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| 32 | 2021-02-23 | throat swelling |
Noticed red blotchy rash around injection site 3cm in diameter; Noticed red blotchy rash around inje...
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Noticed red blotchy rash around injection site 3cm in diameter; Noticed red blotchy rash around injection site 3cm in diameter; Her throat was feeling a little swollen without difficulty swallowing or breathing; This is a spontaneous report received from a contactable pharmacist (reporting for a patient). A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), intramuscular in the left arm on 25Jan2021 13:15 (at the age of 32-years-old) as a single dose for COVID-19 immunization. The patient's medical history was unknown. The patient had no known allergies. It was unknown if the patient had COVID prior to vaccination. It was unknown if the patient was pregnant at the time of vaccination. The patient's concomitant medication was unknown. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular in the left arm on 04Jan2021 12:45 (at the age of 31-years-old) as a single dose for COVID-19 immunization; the patient had no reaction to the first dose. On 25Jan2021, the patient noticed a red blotchy rash around injection site 3 cm in diameter at 13:15. She was treated with diphenhydramine hcl (BENADRYL) 25 mg orally one dose. Her throat was feeling a little swollen without difficulty swallowing or breathing (also at 13:15 on 25Jan2021). She reported similar reactions to bee stings. At 13:25, the rash was almost gone, her throat was feeling better, and she ambulated independently to her vehicle. The clinical outcome of the events was recovered on an unspecified date in 2021.
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| 32 | 2021-02-25 | chills, fatigue, fever, headache |
Fatigue; Headache; fever (~100F); joint pain; chills; facial rash (flat, bright red rash on both che...
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Fatigue; Headache; fever (~100F); joint pain; chills; facial rash (flat, bright red rash on both cheeks and chin); This is a spontaneous report from a contactable consumer (patient). A 32-years-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL8982), via an unspecified route of administration on 24Jan2021 at 12:15 at single dose in left arm for COVID-19 immunisation. Medical history included depression and anxiety. Concomitant medication included sertraline and buspirone, both from unknown date for unknown indication. The patient experienced fatigue, headache, fever (~100f), joint pain, chills, facial rash (flat, bright red rash on both cheeks and chin), all on 24Jan2021 18:30 with outcome of recovering. No treatment was received. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. This case was reported as non-serious.
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| 32 | 2021-03-02 | dizziness |
Cloudy; forgetful; entire right side of body sore; tingling; words jumbled, speech impediment; extre...
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Cloudy; forgetful; entire right side of body sore; tingling; words jumbled, speech impediment; extreme dizziness; tachycardia; This is a spontaneous report from a contactable nurse (patient). This 32-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly on 01Jan2021 at 13:00 (at the age of 32-years-old) as a single dose in the right arm for COVID-19. The patient had no medical history and was not pregnant. The patient did not have COVID-19 prior to vaccination. The patient had no concomitant medications and did not receive any other vaccines within 4 weeks prior to the vaccine. The patient did not have any known allergies. On 01Jan2021 at 14:00, the patient experienced "cloudy," forgetful, tachycardia, entire right side of body sore, tingling, words jumbled, speech impediment, and extreme dizziness. The patient did not receive any treatment for the events. The clinical outcome of "cloudy," forgetful, tachycardia, entire right side of body sore, tingling, words jumbled, speech impediment, and extreme dizziness was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 32 | 2021-03-02 | fever, migraine |
Fever; Migraine; Nausea; Throwing up; This is a spontaneous report from a contactable healthcare pro...
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Fever; Migraine; Nausea; Throwing up; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot: EL3247), intramuscular on the left arm (at the age of 32years) on 27Jan2021 at 14:00 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included migraines, kidney stones and high cholesterol. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The reported adverse events were fever, migraine, nausea, and throwing up on 31Jan2021 with no treatment received on all events. The patient considered the events as non-serious. Did not results in death, non- life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the events was unknown.
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| 32 | 2021-03-03 | dizziness, fever, headache, chills, fatigue |
Fever; myalgia; chills/rigor; severe headache; fatigue; dizziness; This is a spontaneous report from...
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Fever; myalgia; chills/rigor; severe headache; fatigue; dizziness; This is a spontaneous report from a Non-contactable Physician (patient). A 32-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3248), via an unspecified route of administration on 29Jan2021 (at the age of 32-years) at single dose for COVID-19 immunisation. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history includes seasonal allergies. The patient received no concomitant medications. On 29Jan2021 the patient experienced fever, myalgia, chills, rigor, severe headache, fatigue and dizziness. Treatment was received for the events with Ibuprofen and Tylenol. The events had resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 32 | 2021-03-14 | throat swelling, dizziness, headache |
Swollen throat; headache; dizziness; This is a spontaneous report from a contactable healthcare prof...
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Swollen throat; headache; dizziness; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: WL8982, expiry date not reported), via an unspecified route of administration at the left arm on 24Jan2021 10:15 at single dose for COVID-19 immunization. Medical history included food allergy (walnut and pecan allergies). Concomitant medications were not reported. On 24Jan2021, the patient experienced swollen throat, headache and dizziness. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at an urgent care center. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The adverse events resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 29Jan2021. Therapeutic measures were taken as a result of dizziness that included an anti dizziness medication. Clinical outcome of the events was not recovered.
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| 32 | 2021-03-17 | fever, chills |
fever/temperature reached 101 degrees; Chills; Swollen lymph node in left armpit/swollen lymph node ...
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fever/temperature reached 101 degrees; Chills; Swollen lymph node in left armpit/swollen lymph node under her left arm, which is the same side that she received her vaccine; Passed out; Body aches; This is a spontaneous report from a contactable nurse (patient). This 32-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL1283, Expiry Date: Apr2021), via an unspecified route of administration on 27Jan2021 09:00 at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were none. No family history. The patient previously took first dose of BNT162B2 (Lot# EL1283) on 07Jan2021 for COVID-19 immunization. Vaccination facility type was nursing home patient was employed at; administered by pharmacy. No additional vaccines administered on same date of Pfizer suspect. No prior vaccinations received within 4 weeks. No adverse events follow prior vaccinations. Patient had fever: temperature reached 101 degrees, early morning on 28Jan2021; chills on 28Jan2021; body aches: at night of 27Jan2021; passed out: later on day of 27Jan2021, didn't get out of bed, didn't remember passing out. Remembers waking up on the floor; swollen lymph node: under her left armpit/left arm noticed on 28Jan2021, which was the same side that she received her vaccine. Hurts less when she puts her arm down. Really was sore to the point where she had to keep her arm open. She can rest her arm now, but it is still sore. Everything has subsided except for the swollen lymph node. Her energy was back. No relevant tests. Relatedness of bnt162b2 to events for Fever/Chills/Body aches/Passed out/Swollen lymph node in left armpit: Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related. Event relatedness between COVID-19 Vaccine and fever/Body aches/Swollen lymph node in left armpit was Related. Outcome of the event was swollen lymph node was not recovered, outcome of other events was recovering. No investigation assessment.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 32 | 2021-03-21 | dizziness |
After approximately 5 min after receiving the shot i started to feel a strong feeling of dizziness a...
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After approximately 5 min after receiving the shot i started to feel a strong feeling of dizziness along with nausea, i could not stand and fainted, they carried me to a private area where i was picked up by the ambulance, my vital signs were not ok.
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| 32 | 2021-03-21 | cold sweat |
c/o twitching/jerking/clammy skin with minimal responsiveness to commands immediately after vaccine ...
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c/o twitching/jerking/clammy skin with minimal responsiveness to commands immediately after vaccine administration
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| 33 | 2020-12-31 | headache | Headache |
| 33 | 2020-12-31 | fever |
I had a small burning sensation after the initial injection near the injection site. Felt fine for t...
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I had a small burning sensation after the initial injection near the injection site. Felt fine for the rest of the morning and afternoon. In the evening I started to feel feverish. It was at 99.5. When I woke up this morning my fever had progressed to 101.8. I do have soreness near the injection site as well.
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| 33 | 2020-12-31 | headache |
I received the vaccine in the left arm on 12/23 with no immediate symptoms. On 12/24 I had body ache...
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I received the vaccine in the left arm on 12/23 with no immediate symptoms. On 12/24 I had body aches mostly on my left side. On 12/25, I started having a strong headache, focused mostly on the left side. On 12/26 the headache continued and I also noticed swollen lymph nodes on both sides of my neck, and behind my ears. Also, it felt like someone had broken my nose and when I would try to bite down or chew I would have a sharp pain and pressure in my nose and sinuses. On 12/27, the headache continued, and I had severe left eye pain, as well as pain chewing and the swollen nodes, that became painful to touch. On 12/28, I went to my PCP and was tested for covid, which was negative. She diagnosed me with a sinus infection and prescribed amoxicillin. On 12/29, I noticed my scalp had lumps on it that were painful and I had a very itchy spot on my forehead, which became swollen as well to about a quarter size lump. I also had other painful spots on my scalp all over and a continued severe headache and left eye pain. I tried to follow up with my PCP on 12/31, but their office was closed, and the on call nurse referred me to urgent care. More painful, swollen lymph nodes have appeared on my face and neck. I wasn't able to be seen at urgent care until today (1/1), and was then diagnosed with Shingles. I was told to continue amoxicillin and to start taking Valtrex. I am very itchy, mostly on my face, scalp, and left side of my body.
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| 33 | 2021-01-01 | shortness of breath, dizziness |
At 15 minutes post vaccination, I became dizzy, short of breath and felt like I might lose conscious...
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At 15 minutes post vaccination, I became dizzy, short of breath and felt like I might lose consciousness. I was hypertensive, had cramping in my fingers and felt numbness in my toes. I laid flat on the floor for 30 minutes in observation and began to feel better by 11. The same thing happened 3 more times throughout the day.
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| 33 | 2021-01-01 | shortness of breath, sweating, headache, fatigue, dizziness |
Shortness of breath, elevated heart rate, elevated blood pressure, dizzy, diaphoresis. Still had ep...
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Shortness of breath, elevated heart rate, elevated blood pressure, dizzy, diaphoresis. Still had episodes of tachycardia and diaphoresis at 8pm. Following day headache and fatigue.
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| 33 | 2021-01-01 | throat irritation |
Within 2 hours of receiving the vaccine, patient had itchy throat, swollen lip which was confirmed o...
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Within 2 hours of receiving the vaccine, patient had itchy throat, swollen lip which was confirmed on exam by ED physician and she received benadryl which resolve the event.
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| 33 | 2021-01-01 | throat irritation |
within 2 hours of the vaccine, patient had angioedema of lip and itchiness in throat which was verif...
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within 2 hours of the vaccine, patient had angioedema of lip and itchiness in throat which was verified by physlcal exam by the ED physician. She was given benadryl and symptoms improved.
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| 33 | 2021-01-02 | fever, chills, fatigue, headache |
Within the first 12 hours I developed a fever of 102 - 103 degrees farenheit and chills with headach...
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Within the first 12 hours I developed a fever of 102 - 103 degrees farenheit and chills with headache and substantial fatigue. The chills went away after the first day. The 2nd day I still had a fever. Day 3 I had significant nausea in conjunction with headache. These symptoms have continued from days 4 - today, day 11 post vaccine. While they are improving, after the initial fever/ chills my symptoms translated to into seemingly hormonal with nausea, strong food aversions, headaches (that felt hormonal) and 4+ days with substantial constipation and fatigue. It has mirrored the sickness I experienced with both pregnancies however I am not pregnant. I am still experiencing a mixture of fatigue, headaches, nausea and food aversions (food still does not taste normal).
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| 33 | 2021-01-03 | throat irritation |
15 min after the vaccine I was flushed and felt hot , ears felt hot as well. I had a macular rash ...
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15 min after the vaccine I was flushed and felt hot , ears felt hot as well. I had a macular rash on chest and arms. My throat felt itchy and they immediately gave me benedryl. I was tahycardic as well. When I got home from the ER that night I had to take more benedryl and then the next morning I was still itchy and my voice was hoarse so I took more xyzal and famotidine. The rash subsided and I continued taking xyzal twice a day , benedryl and famotidine for a week. After my vaccine the itching did not subside for about 48 hours and it was very difficult to control. I had to take max doses of antihistamines to control the hoarseness In my voice and itching
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| 33 | 2021-01-03 | throat irritation, runny nose |
Approximately 10 minutes after injection patient started to complain of an itchy throat and a metall...
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Approximately 10 minutes after injection patient started to complain of an itchy throat and a metallic taste in her mouth. No acute distress noted. No oral, facial or throat swelling noted. Lungs clear bilaterally and patient moving air without difficulty. Skin warm and dry. Patient speaking clearly and in full sentences. Patient continued to be monitored. Patient complained of slight chest "tightness" and increased mucus production approximately 20 minutes after initial vaccination. Upon exam no acute distress noted. Lungs clear bilaterally. Skin warm and dry. Patient speaking clearly and in full sentences. Patient able to manage oral secretions, no drooling noted. No oral, facial or throat swelling noted. No notable redness or rash observed. EMS called and arrived without incident. Patient discharged by EMS and was advised by them to go home and take a Benadryl. Discussed EMS recommendation with patient and she verbalized understanding and stated that she would call 911 or go to ER if symptoms change or worsen.
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| 33 | 2021-01-03 | throat irritation, runny nose |
Approximately 10 minutes after injection patient started to complain of an itchy throat and a metall...
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Approximately 10 minutes after injection patient started to complain of an itchy throat and a metallic taste in her mouth. No acute distress noted. No oral, facial or throat swelling noted. Lungs clear bilaterally and patient moving air without difficulty. Skin warm and dry. Patient speaking clearly and in full sentences. Patient continued to be monitored. Patient complained of slight chest "tightness" and increased mucus production approximately 20 minutes after initial vaccination. Upon exam no acute distress noted. Lungs clear bilaterally. Skin warm and dry. Patient speaking clearly and in full sentences. Patient able to manage oral secretions, no drooling noted. No oral, facial or throat swelling noted. No notable redness or rash observed. EMS called and arrived without incident. Patient discharged by EMS and was advised by them to go home and take a benadryl. Discussed EMS recommendation with patient and she verbalized understanding and stated that she would call 911 or go to ER if symptoms change or worsen.
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| 33 | 2021-01-03 | weakness |
General weakness requiring assistance to stand.; General weakness requiring assistance to stand; Ras...
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General weakness requiring assistance to stand.; General weakness requiring assistance to stand; Rash on chest/neck; This is a spontaneous report from a contactable Pharmacist. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), intramuscularly on 22Dec2020 13:15 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. None medical history. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient experienced rash on chest/neck. General weakness requiring assistance to stand on 22Dec2020 17:00 with outcome of recovered in Dec2020. The date report was first received from source was 23Dec2020. Patient received Fluid bolus, IV benadryl, IV steroid as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The events were reported as non-serious.; Sender's Comments: The reported events rash on chest/neck and general weakness requiring assistance to stand were likely related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 33 | 2021-01-03 | headache, fever | High fever, headache, tenderness at injection site. |
| 33 | 2021-01-03 | fatigue |
mental cloudiness; bruising of injection site; arm pain; fatigue; This is a spontaneous report from ...
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mental cloudiness; bruising of injection site; arm pain; fatigue; This is a spontaneous report from non-contactable Pharmacist (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at right arm on 19Dec2020 08:15 at single dose for Covid-19 immunization. The Covid-19 vaccine was administered in a hospital facility. Medical history included seasonal allergies, heartburn, and allergies to ethanol. The patient has no Covid prior vaccination. Concomitant medication included cetirizine, esomeprazole, melatonin; all from unspecified date for unspecified indication. The patient did not receive other vaccines in four weeks prior to the Covid vaccine. On 19Dec2020 at 15:00, the patient experienced bruising of injection site (x 1 week), arm pain, fatigue, mental cloudiness (approximately x 1 day). The patient was not tested post vaccination. The patient did not received treatment due to the events. The outcome of the events mental cloudiness, bruising of injection site, arm pain and fatigue was recovered in Dec2020. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event mental impairment cannot be excluded. The information available in this report is limited and this case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 33 | 2021-01-04 | dizziness |
25 minutes after injection got light headed, BP was taken by RN 139/91, face then got red, hot and i...
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25 minutes after injection got light headed, BP was taken by RN 139/91, face then got red, hot and itchy. II was taken to the Emergency Department for further observation. I I also experience some nausea, my tongue was slightly itchy, I had a stomach ache and some redness/swelling round the injection site. At the ED I was given 25 md Benadryl PO and observed for another hour and a half before being discharged.
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| 33 | 2021-01-04 | shortness of breath, fever, cough, fatigue, chills |
Received covid vaccine 1/2 at 2pm. Around 7pm that night, left arm pain and slight itching of whole ...
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Received covid vaccine 1/2 at 2pm. Around 7pm that night, left arm pain and slight itching of whole body. did not think much of it. woke up once in middle of night at 4am with racing heart but went back to sleep. Around 9 am next morning started getting chills, initially mild then severe and developed severe myalgias; could not get out of bed or lift arms or limbs. having chest tightness and shortness of breath. pressing on chest wall hurts, hard to take deep breath. Temps of 99.5 most of morning. started taking tylenol total of 1 gram. 1 hour after tylenol shaking and rigors with sweating. had temp of 101 after tylenol. HR 110 at this time (my baseline is around 60s). O2 sat remained normal. Went to ER for testing for covid in case this was covid--test negative. Felt a little better morning of 1/4--no fever. tried to work 1/2 day; called out sick. lots of brain fog, fatigue mental slowing. still having intermittent chest tightness and sob; feel like i cannot expand my lungs. deep breath makes me cough. had few small red bumps on left antecubital fossa that resolved. i'm a physician, i'm concerned this was a severe reaction and was advised to report this.
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| 33 | 2021-01-04 | nasal congestion | loss of taste & smell, nasal congestion, got tested for COVID-19 on 1/04/2021 and it was Positive |
| 33 | 2021-01-04 | fatigue, headache |
really tired; heart pounding; couldn't sleep; Headache; sore arm; She couldn't sleep because she was...
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really tired; heart pounding; couldn't sleep; Headache; sore arm; She couldn't sleep because she was anxious.; almost felt like her blood pressure was up.; Her heart rate is usually 60-65 bpm, but last night it was up to 75-80 bpm; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EIC9231), via an unspecified route of administration on 29Dec2020 11:30 at single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient was calling to report that she got the COVID vaccine yesterday, and she wanted to put input in on the effects she experienced last night. She is a pharmacy transition specialist. She doesn't have a prescribing doctor. A few hours after, she was really tired. She could have fallen asleep at her desk. Then, last night, her heart was like pounding but not beating fast if that makes since. Her heart rate wasn't up that much, but it felt like it was going to come out of her chest. She couldn't sleep because of it. She had a headache. She received the vaccine at 11:30. She is not as tired today. Yesterday, she could have just laid head back and went to sleep. The rest of the side effects started right after dinner. She couldn't sleep because she was anxious. Her heart rate is usually 60-65 bpm, but last night it was up to 75-80 bpm. It almost felt like her blood pressure was up. This happened right around after dinner. The headache is hanging over into today. It could be still there because she didn't sleep. Her arm is sore still. It isn't serious. The handwriting was bad on her card so it was hard for her to read the lot number. The outcome of the event Headache, sore arm was not resolved, the outcome of the event really tired was resolving, the outcome of the event heart pounding was resolved in Dec2020, while the outcome of the other events was unknown.
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| 33 | 2021-01-04 | throat swelling, dizziness |
tachycardia; dizziness; throat swelling; blotches on chest; palpitations; chest tightness/had residu...
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tachycardia; dizziness; throat swelling; blotches on chest; palpitations; chest tightness/had residual mild chest discomfort and noticed 2 blotches on chest in car; metallic taste in mouth; This is a spontaneous report from a contactable physician (patient). A 33-year-old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) via Intramuscular on 28Dec2020 12:30 PM at single dose in the arm left for COVID-19 immunisation. Medical history included Bee venom (anaphylaxis), hereditary fructose intolerance (HFI, HFI as above but no previous issues with sucrose containing vaccines) and Known allergies: Bee venom (anaphylaxis). Concomitant medications included Linaclotide, Adderall, polyethylene glycol 3350. Roughly 5-7 minutes after injection, the patient experienced palpitations, chest tightness, and metallic taste in mouth - sensations mostly subsided after another 5 minutes so did not report. Left center after 30 mins, the patient had residual mild chest discomfort and noticed 2 blotches on chest in car. Drove home - on the way at 13: 15 (45 mins post vaccine), developed throat swelling, severe chest tightness, tachycardia (HR 130s), and dizziness. Severe symptoms (throat swelling particularly) subsided after 5 minutes but other symptoms persisted for another hour. Used albuterol, had epi pen ready but didn't use. Now 3 hours out, feeling close to baseline. The patient underwent lab tests, which included Covid test post vaccination with Negative result in Dec2020. The patient received treatment for events, which included Albuterol. Outcome of events was recovering.
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| 33 | 2021-01-05 | headache, nerve pain, chills, fever, dizziness | 103 fever, chills, severe muscle pain, hypersensitive nerves, chest pain, headache, lightheaded |
| 33 | 2021-01-05 | fever, chills, dizziness, fatigue, headache |
About 12 hours after I received the second dose of the covid vaccine, I started to get severe chills...
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About 12 hours after I received the second dose of the covid vaccine, I started to get severe chills and headache followed by fever that lasted all night and was up to 101.4 F. The fever improved this morning around 9 am, however I continued to have headache, myalgia, and fatigue all day. I also have intermittent nausea and difficulty standing or walking around because of feeling like I will pass out. I feel slightly improved tonight but still not normal. I called the employee health this morning to inform them.
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| 33 | 2021-01-05 | fever, chills | Body aches, fever over 100.4, joint pain, chills |
| 33 | 2021-01-05 | shortness of breath | Chest Tightness, Flushing, Difficulty breathing |
| 33 | 2021-01-05 | dizziness | DIZZINESS |
| 33 | 2021-01-05 | respiratory tract congestion, throat irritation |
Employee called nurse line, had COVID vaccine left deltoid 12/23 and began having symptoms of tickle...
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Employee called nurse line, had COVID vaccine left deltoid 12/23 and began having symptoms of tickle in throat, sinus headache, minor loss of smell and taste, congestion on 12/30/2020. Tested positive for COVID 1/4/2021.
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| 33 | 2021-01-05 | headache |
Headache, Myalgia, NauseaVomiting, Injection site pain Headache 5 minutes after injection. Nausea an...
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Headache, Myalgia, NauseaVomiting, Injection site pain Headache 5 minutes after injection. Nausea and vomiting 1 hour after injection. Body aches and injection site pain also reported.
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| 33 | 2021-01-05 | fever, headache | Headaches, nausea, slight fever |
| 33 | 2021-01-05 | headache, respiratory tract congestion |
I developed congestion and nasal burning. Loss sense of smell and taste. Headache and muscle aches. ...
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I developed congestion and nasal burning. Loss sense of smell and taste. Headache and muscle aches. I went to medical facility for a COVID19 test on the morning of 12/31/2020. I ended up testing Positive for COVID19.
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| 33 | 2021-01-05 | headache |
I started getting a mild left sided headache that progressively worsened and it became unbearable. N...
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I started getting a mild left sided headache that progressively worsened and it became unbearable. No medication helped and it became so severe that it would wake me up at night. I was seen in the urgent care and PCP office and was diagnosed with cluster headaches. I am still experiencing these symptoms. I never had any type of headaches.
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| 33 | 2021-01-05 | fatigue, dizziness, body temperature increased |
Last night (4 hours after injection) axillary lymphnodes on injection side were enlarged and severel...
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Last night (4 hours after injection) axillary lymphnodes on injection side were enlarged and severely painful. Upon waking this morning axillary lymphnode pain persists, left inguinal lymphnode is painful, moderate to severe fatigue and temperature of 99.9 degrees when checked at work with mild dizziness. Heart palpitations while trying to sleep last night, resting heart rate was 86 BPM higher at times.
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| 33 | 2021-01-05 | headache | Left arm pain and headaches and tiredness |
| 33 | 2021-01-05 | throat pain | SOTROAT, JAW PAIN AND EAR PAIN 3 DAYS POST VACCINATION |
| 33 | 2021-01-05 | shortness of breath | Tacycardia (HR 145) and SOB |
| 33 | 2021-01-05 | fatigue, somnolence |
The effect I had was extreme fatigue day after the vaccine. I couldn't stay awake until my regular b...
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The effect I had was extreme fatigue day after the vaccine. I couldn't stay awake until my regular bed time. This continued for 3 days I had to go to bed super early. The following Sunday I started feeling better.(Estimated date of delivery mid Sept. Pt stated she isn't moving forward with pregnancy).
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| 33 | 2021-01-05 | malaise, chills, fever |
she did not felt great/ felt the worst that she had been feeling; temperature was like 100.3/fever; ...
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she did not felt great/ felt the worst that she had been feeling; temperature was like 100.3/fever; chills; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 33-year-old female patient received bnt162b2 (BNT162B2 also reported as Covid19 Vaccine a Pfizer, lot EH9899, expiry date not reported), via an unspecified route of administration on 29Dec2020, single dose, for Covid-19 immunisation (prevention of Covid-19). Medical history was none. Concomitant medication included PRENATAL VITAMINS. The patient informed she did not felt great the day (29Dec2020) or 2 that when she got the vaccine. She felt the worst that she had been feeling. Her temperature was like 100.3/fever and had chills (29Dec2020). No treatment was taken. The outcome of the events was unknown.
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| 33 | 2021-01-06 | fever, chills |
About 12 hours after receiving the shot, I woke up with chills, body aches, and nausea. Fever peaked...
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About 12 hours after receiving the shot, I woke up with chills, body aches, and nausea. Fever peaked at 100.4. Could not sleep for 4 hours, probably related to the fever. Took 400mg of motrin after 2 hours of fever, temperature was normal by 10 am.
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| 33 | 2021-01-06 | dizziness |
Dizziness; Nausea; This is a spontaneous report from a contactable other hcp, the patient. This 33-y...
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Dizziness; Nausea; This is a spontaneous report from a contactable other hcp, the patient. This 33-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly in the right arm on 28Dec2020 at 07:45 (at the age of 33-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication was reported as none and no other medications were received within 2 weeks of the vaccination. On 28Dec2020 at 08:00, the patient experienced dizziness and nausea. No therapeutic measures were taken as a result of the events. The events resulted in the patient requiring a doctor/clinic visit. The clinical outcome of dizziness and nausea was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 33 | 2021-01-06 | fatigue |
I received the vaccine on 12/18. Sore arm the next day (as expected), but then 2 days later, on 12/2...
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I received the vaccine on 12/18. Sore arm the next day (as expected), but then 2 days later, on 12/21 & 12/22 I was SUPER tired in the afternoon/evening. Seems better 12/23. Felt totally fine otherwise, but definitely had significant fatigue that is not normal for me at all. I still plan to get the 2nd dose as scheduled.
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| 33 | 2021-01-06 | fever, malaise, chills, headache, shortness of breath |
Malaise, fever of 100.6, chills, feeling of shortness of breath, headache, myalgias, arthralgias Las...
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Malaise, fever of 100.6, chills, feeling of shortness of breath, headache, myalgias, arthralgias Lasting less than 6 hours Relieved by oral antiflammatory
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| 33 | 2021-01-06 | headache, fatigue, chills |
Moderate headache, back pain, R arm muscle soreness, moderate fatigue, loss of appetite, hot flashes...
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Moderate headache, back pain, R arm muscle soreness, moderate fatigue, loss of appetite, hot flashes/chills alernating
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| 33 | 2021-01-06 | dizziness |
Patient's arm was feeling tight after the injection, The sleeve seemed to be tightening her arm and ...
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Patient's arm was feeling tight after the injection, The sleeve seemed to be tightening her arm and after the injection she felt all the blood rush down her arm and she stated the injection site came out a bit and had a little bump. She went to the observation area and was feeling faint and light headed. She was taken to a separate room and she became a little faint and was given some water and kept longer for observation. After about an hour shes feeling much better and her color as returned and only feeling slightly light-headed.
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| 33 | 2021-01-06 | fever, headache | Severe Achyness Fever 100.2 Headache Stomach ache |
| 33 | 2021-01-06 | headache, fatigue, chills, fever |
Vaccine received at 3:00 PM on 1/4/2021 10:00 PM: fatigue 1/5/2021: 01:45 AM: Fever 104 F, Chills, B...
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Vaccine received at 3:00 PM on 1/4/2021 10:00 PM: fatigue 1/5/2021: 01:45 AM: Fever 104 F, Chills, Body aches, headache, severe pain in arm of injection. 04:00 AM: Fever 101 F 08:00 AM: Fever 100.4 F. Tylenol taken. Headache and body aches throughout the day. 1/6/2021: headache and body aches most of the day ALL Symptoms gone by 48 hours post vaccine
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| 33 | 2021-01-07 | throat swelling |
10 min post vaccine began c/o tingling in lips and tongue. stated felt like her throat was like a...
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10 min post vaccine began c/o tingling in lips and tongue. stated felt like her throat was like a balloon being blown up. mild anxiety, no sob or diff breathing. no diff swallowing. brought from lobby to exam room. VS taken. 25mg of po benedryl given and 0.3mg epi given SQ at approx 09:20 sat with patient and monitored VS frequently approx q 10m for 60m. oxygen sats remained 98-99% on RA, resp were 20 ( initially with anxiousness down to 14 by discharge. P ave 80s BP ave 130/70s symptoms began to resolve by 30min and were resolved at 60min and pt was release d home pt called when she returned home ( 1hr drive ) and was feeling well with mild tongue thickness sensation . advised to repeat 25mg of benedryl po at 3pm and 9pm today advised to call Emergency Services for any return of sob diff breathing swallowing or sense of airway closing
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| 33 | 2021-01-07 | influenza like illness, chills, malaise | Arm soreness, flu like symptoms, chills, sinus pain, overall sick feeling. |
| 33 | 2021-01-07 | dizziness, sweating, chills, fever |
Began feeling light headed the evening of the vaccine, overnight developed shaking chills, fever of ...
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Began feeling light headed the evening of the vaccine, overnight developed shaking chills, fever of 104 with headache. Took ibuprofen which brought temperature down to 99. Still (on day 2) having some sweats & nausea.
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| 33 | 2021-01-07 | fever, chills, headache | Chills, nausea, vomiting, headache, low grade fever |
| 33 | 2021-01-07 | chills, fever |
Developed fever of 100.6, chills and was tachypneic. Presented to Hospital Emergency department on ...
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Developed fever of 100.6, chills and was tachypneic. Presented to Hospital Emergency department on 1/8/21 at 6 am. Discharged at 10am.
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| 33 | 2021-01-07 | cough | Developed rash, itching on arm and on chest, tingly feet and dry cough, dry mouth |
| 33 | 2021-01-07 | dizziness |
Feeling of lump in throat and lightheadedness. Benadryl 50 mg IM given. Symptoms resolved within 2-3...
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Feeling of lump in throat and lightheadedness. Benadryl 50 mg IM given. Symptoms resolved within 2-3 hours.
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| 33 | 2021-01-07 | chills, headache |
Headache, muscle/joint pain, low fever 99.4, chills, two episode of presyncopal events, and nausea. ...
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Headache, muscle/joint pain, low fever 99.4, chills, two episode of presyncopal events, and nausea. This started at 10pm 1/6 the night of the vaccine and continued untill Friday 1/8 12 noon. It is now the evening and my arms and back are still sore.
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| 33 | 2021-01-07 | chills, fatigue |
Injection site pain 12 hrs post injection. Myalgias, chills, fatigue at 24 hrs.; Injection site pain...
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Injection site pain 12 hrs post injection. Myalgias, chills, fatigue at 24 hrs.; Injection site pain 12 hrs post injection. Myalgias, chills, fatigue at 24 hrs.; Injection site pain 12 hrs post injection. Myalgias, chills, fatigue at 24 hrs.; Injection site pain 12 hrs post injection. Myalgias, chills, fatigue at 24 hrs.; This is a spontaneous report from a contactable physician (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Eh9899), intramuscularly in left arm on 15Dec2020 16:00 at single dose for COVID-19 immunization. There was no medical history (Known allergies (Allergies to medications, food, or other products): No). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: No. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient experienced injection site pain 12 hrs post injection, myalgias, chills, fatigue at 24 hrs on 16Dec2020 07:00 with outcome of recovered. The patient received treatment ibuprofen for the adverse event. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. AE was not resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Serious: no. Seriousness criteria-Results in death: no. Seriousness criteria-Life threatening: no. Seriousness criteria-Caused/prolonged hospitalization: no. Seriousness criteria-Disabling/Incapacitating: no. Seriousness criteria-Congenital anomaly/birth defect: no.
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| 33 | 2021-01-07 | chills, fever, headache | Low-grade fever, body aches, chills, headache, and nausea Symptoms subsided after 24 hours |
| 33 | 2021-01-07 | throat pain, fever, chills |
Symptoms - ? at approximately 18:00 began with body aches, chills and febrile. EE reports Tmax 101....
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Symptoms - ? at approximately 18:00 began with body aches, chills and febrile. EE reports Tmax 101. + sore throat. EE denies COVID-19 exposure without PPE and denies recent travel. EE reports she is pregnant at this time. Last day of work and shift - ? yesterday Home remedies? - 1,000 mg of Tylenol at 08:00 Any improvement? ? mild improvement Recommendation? After completely algorithm, EE meets criteria to be COVID tested and removed from work at this time. EE provided with EH command center and instructions to notify them need for COVID-19 testing. EE educated to notify his manager. EE verbalized back understanding and denied further questions at this time.
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| 33 | 2021-01-07 | dizziness |
Tachycardia and lightheadedness occurred about 10 minutes after injection and lasted for about 30 m...
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Tachycardia and lightheadedness occurred about 10 minutes after injection and lasted for about 30 minutes
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| 33 | 2021-01-07 | dizziness, shortness of breath, throat swelling, sweating |
With in 10 mins of receiving 1st dose, I started to feel hot and light headed, my body became very ...
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With in 10 mins of receiving 1st dose, I started to feel hot and light headed, my body became very hot, I started to sweat and then my throat started to dry up and close. I notified the provider on watch that was monitoring me during my 15 mins after injection and as the walked me to the room I became more and more dizzy, my throat continued to swell and close, my mask was removed where my face was covered with a rash and hives . The dr. Gave me 50 mg benedryl, and a shot of epinephrine. After wards 911 was called, my heart rate was eventually brought down with the epinephrine as my symptoms began to be controlled. An inhaler was administered because I was short of breath. 3 hours later I was stabilized. I then was recommended to go to urgent care rather the emergency room since the wait was 13 hours to be monitored at the local hospital MLK. I went to urgent care near my home at Hoag hospital and they monitored me and gave me a steroid injection IM. I was discharged with an epi pen just in case abs to take benedryl every 6 hours . The following morning 1/8/21, at 8 am the swelling of my throat retuned I became light headed abs my tongue became numb. I was taken to fountain valley hospital where an IV was started, 500 mg of iv benedryl, another epinephrine injection was given abs I remained under surveillance for another 6 hours. They stated that a lot of people are coming with reoccurring episodes of anaphylaxis after the phizer injection.
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| 33 | 2021-01-07 | throat swelling |
Within 5 minutes of administration felt tongue/throat tingling, then felt them starting to swell, ma...
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Within 5 minutes of administration felt tongue/throat tingling, then felt them starting to swell, making it difficult to swallow, flushing feeling, felt like I was getting tunnel vision (how you feel before you pass out). Reported symptoms to RN who administered shot. Given PO liquid benadryl and epi pen injection quickly- symptoms started to fade within 10-15 minutes, tongue tingly for a few hours. Monitored x 1 1/2 hours with frequent VS checks- HR/BP/SaO2 remained within normal limits
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| 33 | 2021-01-07 | dizziness, shortness of breath |
difficulty breathing, light headedness, burning on the left side of chest/was seen in the ER, sympto...
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difficulty breathing, light headedness, burning on the left side of chest/was seen in the ER, symptoms subsided
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| 33 | 2021-01-07 | cough, fever |
muscle pain; cough; fever/have high fever above 102; injection site pain; This is a spontaneous repo...
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muscle pain; cough; fever/have high fever above 102; injection site pain; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, intramuscular on right arm on 28Dec2020 17:00 at a single dose for COVID-19 immunization. Medical history was reported as none. Patient was not pregnant. Patient has no known allergies. The patient's concomitant medications were not reported. The patient reported she experienced symptoms like fever, injection site pain on 28Dec2020 (also reported as 09Dec2020, for clarification), muscle pain on an unknown date, and cough in Jan2021. She had high fever above 102 on 29Dec2020, one day after the vaccination and on the 5th day she started to cough. Patient did not receive any treatment for the events. Outcome of the events was not recovered. Information on the Lot/batch number has been requested.
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| 33 | 2021-01-08 | chills |
Body aches and chills. Requiring Motrin 600mg to relieve pain. Even with 600mg of Motrin, body aches...
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Body aches and chills. Requiring Motrin 600mg to relieve pain. Even with 600mg of Motrin, body aches are still felt present. Relieved pain from 8/10 to a 1/10.
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| 33 | 2021-01-08 | chills, body temperature increased | Chills and fever (99.68 F) |
| 33 | 2021-01-08 | headache, fatigue, chills, dizziness |
Day 1: Chills, severe pain in injection site arm including muscular and joint pain. Pain down entire...
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Day 1: Chills, severe pain in injection site arm including muscular and joint pain. Pain down entire arm radiating up neck. Day 2: fatigue, dizzy, lightheaded Day 3: vomiting Day 4: vomiting and severe headaches
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| 33 | 2021-01-08 | headache, lethargy | Headache, extreme lethargy, full body hives, eyes swollen . Symptoms lasted for about 48 hours. |
| 33 | 2021-01-08 | fatigue |
I experienced soreness of left arm in a couple of hours after the shot with mild irritation and redn...
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I experienced soreness of left arm in a couple of hours after the shot with mild irritation and redness on the injection site, but symptoms all went away in 1-2 days. However, in one week after the vaccination (1/5/21), I started to develop lymphadenopathy under my right arm, and fatigue.
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| 33 | 2021-01-08 | cough, throat pain |
I woke up with extreme sore throat and post nasal drip. I had an extreme cough. I wen to the urgent ...
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I woke up with extreme sore throat and post nasal drip. I had an extreme cough. I wen to the urgent care and got a PCR covid test which was negative/.
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| 33 | 2021-01-08 | dizziness | c/o chest pressure then lightheaded |
| 33 | 2021-01-09 | fever, chills, dizziness | Fever. Chills. Dizziness. Vomiting. Cramping |
| 33 | 2021-01-09 | fatigue |
I started having Diarrhea and was fatigue that began the morning after the vaccine at 05:48 1/9/21 ...
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I started having Diarrhea and was fatigue that began the morning after the vaccine at 05:48 1/9/21 and continued throughout the day hourly until the following day 0030 1/10/21.
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| 33 | 2021-01-09 | sweating, fever |
Myalgia, Fever, Diaphoresis. Onset was approx. 12 hours after 2nd dose of the Pfizer-BioNTech COVID...
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Myalgia, Fever, Diaphoresis. Onset was approx. 12 hours after 2nd dose of the Pfizer-BioNTech COVID 19 vaccine. Symptoms lasted approx. 16 hours. Symptoms were relieved with otc Tylenol and Ibuprofen.
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| 33 | 2021-01-10 | fever, headache |
1). Headache (on &off) since 1/6. Tylenol and ibuprofen seem to be effective. 2). Fever with Temper...
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1). Headache (on &off) since 1/6. Tylenol and ibuprofen seem to be effective. 2). Fever with Temperature btn 99-100.3 these past three days. 3). Pulse (btn 104-110) the night of 1/6. 4). Muscle aches and swelling at injection site. This has been my biggest obstacle. I am having a hard time lifting and typing. . - I have been utilizing ice packs, range of motion/exercise, ibuprofen.
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| 33 | 2021-01-10 | headache, fatigue |
After receiving the vaccine on 1/5/2021 I had no symptoms initially and for then next 2 days. On 1/...
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After receiving the vaccine on 1/5/2021 I had no symptoms initially and for then next 2 days. On 1/8/21 at around 10:00am I got a headache of moderate severity behind my right eye and at right temple. It was associated with nausea and fatigue. I took 800mg ibuprofen and 4mg zofran. At 12:00 I left work and went home and slept for 4.5 hours between 12:30 and 5pm. I woke up at 5pm and had minimal residual headache in the right temple. After going to sleep from 8pm to 6am, I awoke on 1/9/21 and my headache was completely resolved. I do have a history of migraine headaches. This headache and associated nausea felt like my previous migraine headaches and the course was similar to my previous headaches.
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| 33 | 2021-01-10 | dizziness |
Anaphylaxis within 5 minutes of dose given. Tachycardia 130-140s, hot body temperature, trouble swal...
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Anaphylaxis within 5 minutes of dose given. Tachycardia 130-140s, hot body temperature, trouble swallowing, lightheaded/dizzy, ekg changes, feeling like I was going to pass out even when in bed. IV fluids, benedryl, soul-medrol, famotadine and IM epi given.
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| 33 | 2021-01-10 | fatigue, chills | Body Aches, Chills, tiredness |
| 33 | 2021-01-10 | weakness, fever, headache, chills, fatigue | Chills, fever, body aches, weakness, fatigue, fever, headache. All lasting about 24hrs. |
| 33 | 2021-01-10 | chills, fever, headache, fatigue | Chills, fever, body aches, fatigue, head ache. Most lasting 24 hrs |
| 33 | 2021-01-10 | fever | FEVER 102 chills began 1/8/21 |
| 33 | 2021-01-10 | fever, chills | Fever, chills |
| 33 | 2021-01-10 | chills, fever | Fever, chills and body aches |
| 33 | 2021-01-10 | chills, fever |
I received second covid vaccine on 11/8/21 at 7:45am. That night around 7:30pm I started experiencin...
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I received second covid vaccine on 11/8/21 at 7:45am. That night around 7:30pm I started experiencing body aches and chills. The morning of 1/9/21 I developed a fever, head ache and noticed a red, tender area the size of a penny at the injection site. During the weekend the area around the injection site continued to grow. 1/11/21 I noticed the area is itchy, red, tender/tight feeling, and warm. Pain only when the area is touch. This area is 3.5inchs W by 3 inchs L.
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| 33 | 2021-01-10 | fatigue, headache |
Immediately and for 2 days after receiving the vaccine, I had no symptoms. 1/8/2021 at 10:00am I de...
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Immediately and for 2 days after receiving the vaccine, I had no symptoms. 1/8/2021 at 10:00am I developed a headache of moderate severity at right temple and behind right eye with associated nausea and fatigue. I took ibuprofen 800mg, zofran 4mg, and left work at 12:00pm. I was able to sleep from 12:30pm to 5:00pm and when I awoke, symptoms were improved with mild residual headache in left temple. After sleeping through the night, I awoke 1/9/21 and the headache and nausea had completely resolved. This headache was similar in quality and course to previous migraines that I have had and may get 1-2 times per year and have had since about age 12.
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| 33 | 2021-01-10 | fatigue | Main in Arm , Fatigue Was tested positive for Covid 9 days later |
| 33 | 2021-01-10 | headache |
On Sunday 12/20 I started to get a significant sharp headache on the left side that radiated down my...
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On Sunday 12/20 I started to get a significant sharp headache on the left side that radiated down my left neck and arm to the point of injection site. My left arm was also sore as to be expected with typical injection but this sensation was different. It caused a sharp neuromuscular pain that was also itchy/burning. Extended in the region of sternocleidomastoid site. No rash development but seemed like symptoms of shingles. Continued through until approx 12/26/20. Improved with heat pack, Tylenol and Motrin. Was evacuated by physician on 12/21/20 with no testing or medication provided as symptoms were unclear.
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| 33 | 2021-01-10 | headache |
Patient experienced flushing and headache approximately 15 minutes post-vaccination. Patient's vital...
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Patient experienced flushing and headache approximately 15 minutes post-vaccination. Patient's vital signs were WNL. Patient provided analgesic for headache, but declined antihistamine.
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| 33 | 2021-01-10 | fever, weakness, fatigue, migraine |
Red, swollen, itchy arm for 4days straight Migraine day 2 Fever 102 afternoon of day 2 with chills ...
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Red, swollen, itchy arm for 4days straight Migraine day 2 Fever 102 afternoon of day 2 with chills and pins and needles sensation over entire body weakness/tiredness late afternoon
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| 33 | 2021-01-10 | chills, fever | Redness at site of injection, pain at site of injection, fever/chills, joint aches |
| 33 | 2021-01-10 | fever, dizziness, chills, weakness |
Redness, itching, swelling, hot to the touch at injection site 4days in a row, fever 102degrees F on...
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Redness, itching, swelling, hot to the touch at injection site 4days in a row, fever 102degrees F on 2nd day with chills and tingly/prickly feeling all over, weakness/dizziness
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| 33 | 2021-01-10 | body temperature increased, malaise |
She reports she had second vaccine on Jan.8th and developed a temp. 102, body aches, felt horrible. ...
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She reports she had second vaccine on Jan.8th and developed a temp. 102, body aches, felt horrible. She called PCP and had COVID swab 1/10 at urgent care with neg. result.
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| 33 | 2021-01-10 | sweating, dizziness |
Within 5 minutes of receiving vaccine I became diaphoretic, nauseated, dizzy, hypertensive, and tach...
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Within 5 minutes of receiving vaccine I became diaphoretic, nauseated, dizzy, hypertensive, and tachycardic
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| 33 | 2021-01-10 | fatigue |
fatigue, muscle aches, painful vaginal and oral ulceration, onset of Behcets syndrome following 7 ye...
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fatigue, muscle aches, painful vaginal and oral ulceration, onset of Behcets syndrome following 7 years without incidence
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| 33 | 2021-01-10 | fever, fatigue, headache, malaise, chills |
fever of 105.6 15 hours from injection. Headache at a 10 of 10, chills, fatigue, shaking from fever,...
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fever of 105.6 15 hours from injection. Headache at a 10 of 10, chills, fatigue, shaking from fever, loss of bladder control due to uncontrollable shaking from fever, body aches. Fever up and down. Currently 48 hours out from vaccine and still overall not feeling well and currently febrile at 100.9
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| 33 | 2021-01-10 | fatigue, fever, malaise, chills |
malaise, fever, total body aches, chills, fatigue, extremity pain, ankle pain, spine pain, pain at i...
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malaise, fever, total body aches, chills, fatigue, extremity pain, ankle pain, spine pain, pain at injection site, muscle pain
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| 33 | 2021-01-10 | dizziness, sweating |
patient felt dizzy and nauseous a few hours after the injection. later felt hot and sweaty, increase...
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patient felt dizzy and nauseous a few hours after the injection. later felt hot and sweaty, increased dizziness, leg weakness, tingling in thighs
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| 33 | 2021-01-10 | dizziness, fever, throat pain, headache, fatigue |
reports she had the second pfizer vaccine on Jan. 8. She did not have any reactions from the first ...
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reports she had the second pfizer vaccine on Jan. 8. She did not have any reactions from the first dose. Within 2 hours of having the booster she had a sore throat and HA. Saturday she had the same symptoms. Sunday = worse HA, fatigue like " i was hit by a truck" nausea and vomiting. Today, 1/11 she woke up with fever 101.3, took Tylenol and ibuprofen and it went down; dizzy and vomiting early this morning around 5am. Feeling slightly better now at 1130. However pending COVID results due to multitude of sx?s = may not be reaction to Booster, but rather actually COVID.
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| 33 | 2021-01-11 | skin warm, discomfort |
24 hours after inj L axillary LN enlarged about the size of a baseball very tender and warm to the t...
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24 hours after inj L axillary LN enlarged about the size of a baseball very tender and warm to the touch. Also swelling on L side of chest. Taking nsaid ATC but pain and swelling has persisted - pressure radiates to L scapula.
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| 33 | 2021-01-11 | dizziness, shortness of breath, weakness |
As per Vaccine recipient -incident happened at home , Initial onset of dizziness, shortness of breat...
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As per Vaccine recipient -incident happened at home , Initial onset of dizziness, shortness of breath and heart racing. Then respirations were slowing and patient felt like she was going to pass out , like that pending doom sort of feeling. Patient turned very pale and was presenting black and bluish under her eye region with blue lips. At that time ,she tried to hyper ventilate herself to pink back up again, after a few minutes she regained color but was still very weak and was trembling, her respirations returned to mostly normal at that time me . She laid down to rest and then her toes started involuntarily twitching , they eventually stopped after 10-15.Whole episode lasted about half hour to 45 mins.
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| 33 | 2021-01-11 | fever, cough | Body aches, cough, fever |
| 33 | 2021-01-11 | chills, dizziness, sweating |
Chills, aching body, sweating, nausea, upset stomach/vomiting, dizziness, loud static ringing in ear...
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Chills, aching body, sweating, nausea, upset stomach/vomiting, dizziness, loud static ringing in ears while dizzy/vomiting, injection site soreness. Vomiting subsided but other side effects remain in the afternoon the day after vaccination.
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| 33 | 2021-01-11 | chills, fever, cough, headache |
Coughing; chills; she is feeling like a headache, might be from all the coughing; she threw up a yel...
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Coughing; chills; she is feeling like a headache, might be from all the coughing; she threw up a yellow stuff, I think the yellow mucous or acid; Fever; This is a spontaneous report from a contactable consumer (patient's spouse) via a Pfizer-Sponsored Program, Pfizer First Connect. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EL1284) via an unspecified route of administration on 04Jan2021 (at the age of 33-years-old) as a single dose for COVID-19 immunization. Medical history was reported as "none". Concomitant medications were not reported. The patient experienced "coughing", "chills", "she is feeling like a headache, might be from all the coughing", "she threw up a yellow stuff, I think the yellow mucous or acid" and "fever", all on unspecified dates. It was reported that "the reporter called concerned about his wife who got the Pfizer BioNTech COVID-19 vaccine "yesterday" and then she started coughing and experienced a fever." The reporter stated "she was coughing a lot and she threw up a yellow stuff, I think the yellow mucous or acid or whatever. She had a fever that peaked till 100. I gave her Aspirin, it dropped down to 98 at the moment, but she was still having chills." The reported stated that "I just gave Aspirin for the fever. She said at the back of her neck you know she said that she is feeling like a headache, might be from all the coughing." The patient underwent lab tests reported as "got blood work for allergies and stuff like that". When inquired regarding the indication, the reporter stated, "she was caring for my uncle who is 65 and older". The reported stated "I feel that it is recovering, it's getting better". The clinical outcome of the event "chills" was not recovered/not resolved whereas the clinical outcomes of the events "coughing", "she is feeling like a headache, might be from all the coughing", "she threw up a yellow stuff, I think the yellow mucous or acid" and "fever" were all unknown.
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| 33 | 2021-01-11 | headache | Fainted twice and hit her head when falling, has head ache and abrasions on her face. |
| 33 | 2021-01-11 | fever, chills, headache |
I received the vaccine yesterday at 9am and I start noticing the side effects from the vaccine at mi...
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I received the vaccine yesterday at 9am and I start noticing the side effects from the vaccine at midnight. I had body aches, chills, fever, and now I have a headache.
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| 33 | 2021-01-11 | headache, chills, fatigue |
Local site pain immediately; headache; chills; fatigue; general body aches; BNT162B2 , 17Dec2020 Dos...
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Local site pain immediately; headache; chills; fatigue; general body aches; BNT162B2 , 17Dec2020 Dose number 1, 05Jan2020 Dose number 2; Pregnant at the time of vaccination?: Yes/received BNT162B2; Pregnant at the time of vaccination?: Yes/Pregnant at the time of vaccination?: Yes/received BNT162B2; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable nurse. This is the mother report. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: El0140), intramuscular on 17Dec2020 18:30 (dose number 1, right arm) and on 05Jan2021 18:30 (dose number 2, right arm) at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included an unspecified prenatal drug, sertraline hydrochloride (ZOLOFT), and acetylcarnitine hydrochloride (NEUROTIN). The patient was pregnant at the time of vaccination. No other vaccines in four weeks was taken. Patient has no COVID-19 prior vaccination. Patient was not tested for COVID-19 post vaccination. The patient experienced Local site pain immediately, headache, chills, fatigue and general body aches next day on 06Jan2021. 09:00. No treatment was given. Event outcome was recovering. The reporter assessed the events as non-serious.
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| 33 | 2021-01-11 | fever, headache, chills | Patient describes pain at the injection site, fever, chills, headache, neck pain body aches |
| 33 | 2021-01-11 | fever, headache, chills |
Patient reports pain at the injection site, then developed chills and fever, body aches, muscle ache...
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Patient reports pain at the injection site, then developed chills and fever, body aches, muscle aches. Also reports headache and neck pain.
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| 33 | 2021-01-11 | headache, throat pain, fatigue | Severe Nausea, Headache, Fatigue, Body aches. kidney stones and sore throat. |
| 33 | 2021-01-11 | headache, fatigue, sweating, fever, chills |
Woke up at 2 am to fever of 100.3, body aches, chills/sweating. Fever subsided at 10 am but body ach...
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Woke up at 2 am to fever of 100.3, body aches, chills/sweating. Fever subsided at 10 am but body aches and exhaustion remain. Headache present at 10 am.
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| 33 | 2021-01-12 | chills |
01/11/2021 at 5pm started with diarrhea, chills, body aches. 01/12/2021 06:00pm facial swelling, l...
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01/11/2021 at 5pm started with diarrhea, chills, body aches. 01/12/2021 06:00pm facial swelling, lip swelling, hives. Started Benadryl at home on 01/12/2020. Seen by walk in PMD office 01/13/2021. MD prescribe, 60mg prednisone and to continue Benadryl, 50mg as needed.
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| 33 | 2021-01-12 | cold sweat, malaise, dizziness |
Around 12:00 pm not feeling well. Clammy, nauseated, dizzy and felt like was going to pass out. To e...
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Around 12:00 pm not feeling well. Clammy, nauseated, dizzy and felt like was going to pass out. To emergency department for evaluation. Treated with IV fluids and antiemetics and discharged home.
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| 33 | 2021-01-12 | chills, migraine, fatigue | Body aches, chills, migraine, nausea, fatigue >48 hours. |
| 33 | 2021-01-12 | weakness, dizziness |
Developed dizziness, chest pain, tingling of hands/feet, headache, trouble swallowing, weakness, sti...
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Developed dizziness, chest pain, tingling of hands/feet, headache, trouble swallowing, weakness, stiff joints. Went to ED.
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| 33 | 2021-01-12 | chills, fatigue | Elevated heart rate, chills, fatigue. |
| 33 | 2021-01-12 | dizziness, discomfort | Felt "heavy" and dizzy. Blood pressure was low. Observed and discharged at 1:25. |
| 33 | 2021-01-12 | fever, headache | Fever of 101.3, body aches and headache. Lasted 6-9hours. Treated with Tylenol and Ibuprofen. |
| 33 | 2021-01-12 | chills, fever, headache, fatigue | Fever, chills, nausea, headache, fatigue, and body cramps. |
| 33 | 2021-01-12 | headache, fever, chills, fatigue |
Moderate-Severe chills, fever (maximum temperature: 101F), moderate body aches/joint pain, moderate ...
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Moderate-Severe chills, fever (maximum temperature: 101F), moderate body aches/joint pain, moderate headache, moderate fatigue, fainted twice
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| 33 | 2021-01-12 | dizziness |
PT sts after first dose she did not experience any Sx. Second dose in series 28 days later, PT wait...
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PT sts after first dose she did not experience any Sx. Second dose in series 28 days later, PT waited in observation area. While seated, she began to feel lightheaded and "hot." BP 114/70, HR 74, RR 16. Drank water on provider orders,. Neg LOC or confusion observed. STS cool air helps. By PT request, she attempted to stand which brought back symptoms. PT observed to have blanched appearance and was placed on stretcher with feet raised on 2 LPM O2, second vitals set 1115/74, HR 72, RR 18. When attempting to sit up after 15 minutes dizziness returned and nausea began. 3rd vitals set 119/79, HR 63, RR 18, O2 increased to 3 LPM by provider, PT occasionally sat up to drink water as her mouth felt dry and dizziness was persistent. 30 minutes after symptoms began, medical staff noted new onset of confusion. PT sts Sx began to resolve 55 minutes after onset. PT removed from O2 and was able to walk without aid to awaiting vehicle.
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| 33 | 2021-01-12 | dizziness, headache, fatigue |
Pfizer-biontech covid-19 vaccine eua Dizzy, light headed, hot, ears ringing, mild headache, tiredne...
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Pfizer-biontech covid-19 vaccine eua Dizzy, light headed, hot, ears ringing, mild headache, tiredness, fatigue,
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| 33 | 2021-01-12 | dizziness, shortness of breath, sweating |
Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing st...
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Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing star" as well feeling sob, throat tightness, sweaty hands. Has no PMHx. Not taking any medications Allergies: None. Denies any food allergies. Has gotten Flu shot yearly w/o any side effects. No prior allergic reaction to vaccines. Temp 98.4, BP 140/92 mm Hg, 142/87 mm Hg, HR 120 /min, 158 /min, RR 24 /min, Oxygen sat % 99 %. Exam: in acute distress, + erythema macular rash noted on forehead/periorbital region. Notice sweaty palms/hand tremors. Throat: a bit swollen tongue. Heart: sinus tachy. Lungs: no stridor, no intercostal retraction seen, clear to auscultation bilaterally, no wheezes, rales. Given Benadryl 50mg QD and Epi-pen (left thigh) and given 2 puff of Proventil inhaler. Pt drank 1-2 cups of water. Called 911. After Epi-pen, her HR trended down from 158 - > 120 - > 99 (in 1-2 min). Pt felt better, rash on her forehead/occipital region subsides after 10-15 min. Her shakiness of hand minimal. Her SpO2: 99 % (remains the same) Still feel a bit tightness of her throat (discomfort when swallowing). Her breathing is stable and talking w/o any discomfort by the time the ambulance came over. Her repeated BP: 142/87, HR: 99. I advised to take her to ER for close monitoring (risk of possible developing another reaction).(NEXT PAGE)
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| 33 | 2021-01-12 | chills, fever |
Radiating pain to underneath left arm and down left side of trunk, chills and fever. Pain is worse t...
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Radiating pain to underneath left arm and down left side of trunk, chills and fever. Pain is worse than just injection site pain
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| 33 | 2021-01-12 | headache, fatigue |
Received 2nd dose Sunday 3rd. Monday was extremely fatigued with muscle aches, headache, and injecti...
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Received 2nd dose Sunday 3rd. Monday was extremely fatigued with muscle aches, headache, and injection site redness, pain, swelling, and itching developed on arm where vaccine was administered. Tuesday 1/05 fatigue improved however rash started to develop in right arm. Took Zyrtec and rash improved. Last reported a new rash developed improved on right and left thighs that is painful. Medications taken this time were Benadryl.
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| 33 | 2021-01-12 | fatigue |
Received the 1st dose of COVID vaccine, felt well when she left, but developed a lot of fatigue and ...
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Received the 1st dose of COVID vaccine, felt well when she left, but developed a lot of fatigue and was in bed by 7 pm, very unusual for her. She woke up next day and had some swelling on her forehead and generalized itching. She took an Allegra and facial swelling resolved. No perioral swelling or lesions. No erythema. Then had 3 episodes of vomiting. Still feels nauseated. She contacted her PCP, who advised being seen. Pt uses Singulair at night, Allegra or Zyrtec in morning if she is itchy. Pt denies cough, shortness of breath, abdominal pain, diarrhea, skin irritation. For Nausea and vomiting, intractability of vomiting not specified, unspecified vomiting type- ondansetron ODT (ZOFRAN ODT) 4 mg oral tablet,disintegrating; Dissolve 1 tablet on tongue and swallow every eight hours as needed for nausea/vomiting. Dispense: 15 tablet; Refill: 0. Pt appears well. No facial swelling. History consistent with allergic reaction to COVID vaccine. No evidence of anaphylaxis.Pt to self-report to Occ Health and agency. I also left message at Occ Health. Zofran ordered prn nausea. Pt has an Epipen. She lives with her husband, who can also monitor her. To ED if she develops fwelling, shortness of breath, cough, wheezing, persistent vomiting, or otherwise worsens.
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| 33 | 2021-01-12 | headache, chills |
Started with a mild dull headache that progressed to throbbing, stabbing, headache that was aggravat...
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Started with a mild dull headache that progressed to throbbing, stabbing, headache that was aggravated by lights, sounds, movement. Balance was affected and was unsteady on feet, legs were weak and painful to move/stand or walk. Needed assistance to walk or move. Body chills noted that no matter how many layers applied or blankets or hot shower/bath helped. Nausea was reported but no diarrhea. Along with the leg pain, back and body aches were noted that made standing, sitting or laying extremely uncomfortable.
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| 33 | 2021-01-12 | throat irritation, dizziness |
Vaccine at 1630. vomiting, lightheaded at 1650. BP dropped 20 points over the course of 37 minutes. ...
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Vaccine at 1630. vomiting, lightheaded at 1650. BP dropped 20 points over the course of 37 minutes. Throbbing left arm at 1718. Scratchy throat at 1735. Abdominal cramping at 1740. Epi 0.3 mg IM given 1741. Transported to ED .
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| 33 | 2021-01-12 | dizziness |
Within minutes of receiving the vaccine Pt said she developed a "fruity" taste in her mouth. She sai...
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Within minutes of receiving the vaccine Pt said she developed a "fruity" taste in her mouth. She said she got dizzy, extremely hot and felt like she was "swaying" She said she also got what she described as "menstrual like cramps" that radiated all around her abdomen and back. She was under observation as advised per Pfizer protocol. An associate of the Pt noticed she passed out for a second she then turned beet red from her head to her neck as we could see. The associate yelled for us to grab a BENADRYL. They hooked her up to a BP machine and she did present with a spike in BP. After a few minutes, the redness and symptoms subsided. She was observed by the medical staff at the facility.
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| 33 | 2021-01-12 | fever, headache, chills | fever, chills, body aches and headache x 8 hours, supportive care with Tylenol, fluids and rest |
| 33 | 2021-01-12 | fever, headache, chills | fever, chills, nausea, headache |
| 33 | 2021-01-12 | fatigue, malaise, headache |
headache that comes and goes and was just there; Nausea; Feeling unwell; Had some fatigue as well; I...
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headache that comes and goes and was just there; Nausea; Feeling unwell; Had some fatigue as well; In few minutes I started feeling really hot; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: "EL324U"), via an unspecified route of administration on 03Jan2021 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced headache that comes and goes and was just there, nausea, feeling unwell, some fatigue, and feeling hot. The patient took ibuprofen and acetaminophen (TYLENOL) for the headache; but did not seem to help. The clinical outcomes of headache, nausea, feeling unwell, fatigue, and feeling hot were unknown.
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| 33 | 2021-01-12 | dizziness |
per patient about 15 minutes after receiving dose she experienced some numbness in her face and some...
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per patient about 15 minutes after receiving dose she experienced some numbness in her face and some dizziness similar to how she feels after eating calamari. Patient was talking OK but was given 50mg oral diphenhydramine at 1:03pm, did not report feeling any worse/was feeling slightly better after 30 minutes
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| 33 | 2021-01-12 | headache, fever, chills |
reports symptoms of HA, fever, joint pain, chills on 1/9, developed chest pain on 1/11, went to ED a...
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reports symptoms of HA, fever, joint pain, chills on 1/9, developed chest pain on 1/11, went to ED at facility on 1/11 and was dx with pleurisy, tx with medication, reposrts feeling better 1/13.
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| 33 | 2021-01-13 | headache, body temperature increased |
Achy, feeling cold, headache, TMAX 99.8. No treatment and no improvement. Outcome: Will continue to...
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Achy, feeling cold, headache, TMAX 99.8. No treatment and no improvement. Outcome: Will continue to monitor symptoms.
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| 33 | 2021-01-13 | chills, headache, dizziness, shortness of breath |
Approx 15 mins post vaccination began having chills, slight dizziness. Continued. Approx 2hr post v...
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Approx 15 mins post vaccination began having chills, slight dizziness. Continued. Approx 2hr post vaccination began having chest tightness. Approx 8hrs post vaccination began having intense joint/bone and muscle pain , rapid heart rate, shortness of breath at times. All of these symptoms continued until 1/14/21 until approx 8am. Still experiencing slight dizziness and headache.
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| 33 | 2021-01-13 | fatigue, chills, fever, headache |
Approx 9 hours after receiving second dose of Pfizer COVID-19 vaccine, I began having uncontrollable...
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Approx 9 hours after receiving second dose of Pfizer COVID-19 vaccine, I began having uncontrollable chills, could not get warm, spiked a fever of 100.4, severe body aches, barely could not move. It was all I could do to finish my shift at work, drive home, get in the shower, and pass out in bed to sleep. I slept a good solid 10 hours, woke up for work...fever was then gone and chills, but I had a severe headache, still had severe body aches/fatigue, but I also lost my sense of taste and smell. I ate a waffle which tasted like cardboard, drank cranberry juice (my mouth puckered like it was tart, but I could not taste it at all). I reported to work but was immediately sent home by my employee health nurse to be seen by a health care provider and to be tested for COVID-19. I went home and slept an additional 5 hours, did not do anything at home but rest, and slept a solid 12 hours straight that night. Still could not smell and taste. The following day, I could smell things like Vicks vapor rub and I could taste things minimally like when I initially bit into them, or on the back end if that makes sense. Still had body aches and fatigue, but nothing like that previous day or the night before that. I was then told that evening my PCR test was negative, and I could report to work the following day. 1/14/2021, I felt almost completely back to normal, and I could smell and taste.
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| 33 | 2021-01-13 | night sweats, chills |
Chills; Night sweats; Body aches; This is a spontaneous report from a contactable other healthcare p...
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Chills; Night sweats; Body aches; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL1284) intramuscular in left arm on 05Jan2021 at 14:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 06Jan2021 at 19:00, the patient experienced chills, night sweats and body aches. No treatment given.The outcome of the events was recovering.
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| 33 | 2021-01-13 | fatigue, dizziness, headache, chills |
Chills; light headed; body aches; headache; fatigue; injection site pain; This is a spontaneous repo...
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Chills; light headed; body aches; headache; fatigue; injection site pain; This is a spontaneous report from a contactable other-HCP. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EH9899), via an unspecified route of administration on 29Dec2020 11:15 at single dose for covid-19 immunisation. Medical history was none. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC). The patient experienced Chills, light headed, body aches, headache, fatigue, injection site pain on 30Dec2020 02:00. All events were non serious. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolved.
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| 33 | 2021-01-13 | fatigue, fever |
Date of symptom onset ? 1.13.21? Symptoms - ? around 3:00 pm EE reports feelings of fatigue and ? f...
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Date of symptom onset ? 1.13.21? Symptoms - ? around 3:00 pm EE reports feelings of fatigue and ? felt off.? At approx. 0330 (1/14), + fever (Tmax 100.4), resolution of fever with 400 mg of motrin. Temp 98.2 at time of call (07:30). Last day of work and shift - ? today Home remedies? - motrin 400 mg at 0700 Any improvement? - yes Recommendation? EE encouraged to continue to monitor symptoms and to contact EH vaccine support line with further questions or concerns. EE asked if she was able to attend work as she had a fever this am. EE notified of changes in the Redcap survey and verbalized back understanding. EE denied further questions at this time.
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| 33 | 2021-01-13 | chills, fatigue |
Fatigue; Chills; This is a spontaneous report from a contactable Nurse (patient). A 33-year-old fema...
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Fatigue; Chills; This is a spontaneous report from a contactable Nurse (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 05Jan2021 08:00 in left arm, via an unspecified route of administration at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date for covid-19 immunization. The patient experienced fatigue and chills on 05Jan2021 22:00 with outcome of recovering. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for the adverse event. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Information on the lot/batch number has been requested.
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| 33 | 2021-01-13 | chills, fever, headache | Fever, painful arm, severe headache, chills, muscle aches, initial nausea |
| 33 | 2021-01-13 | fatigue |
First day: Sore arm at injection site Second Day: Whole Body Aches, Fatigue and later in the evening...
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First day: Sore arm at injection site Second Day: Whole Body Aches, Fatigue and later in the evening sore right underarm(OTC's used and alleviated symptoms) Third Day: Swollen underarm on the Right side that is painful to the touch(OTC's used, Hot/Cold compresses with little relief)
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| 33 | 2021-01-13 | fever |
I received my first dose on 12-21-2020 and at night I had a high fever, tachycardia, tremors. I also...
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I received my first dose on 12-21-2020 and at night I had a high fever, tachycardia, tremors. I also had joint pain, myalgia.
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| 33 | 2021-01-13 | nasopharyngitis, chills, dehydration, dizziness |
Inability to think clearly/slowed reaction time/knowing the right steps to do a process but unable t...
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Inability to think clearly/slowed reaction time/knowing the right steps to do a process but unable to execute timely or well Chills/freezing/cold sweats Nausea, GI distress Dizziness/lightheaded/feelings of severe dehydration/feeling unstable on feet Anterior chest burning
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| 33 | 2021-01-13 | headache |
Right eye and cheek is swollen; Right eye and cheek is swollen; right sided headache; right sided ne...
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Right eye and cheek is swollen; Right eye and cheek is swollen; right sided headache; right sided neck muscle spasm and tightness.; right sided neck muscle spasm and tightness.; This is a spontaneous report from a contactable Other HCP. This Other HCP (patient) reported that the 33-year-old female patient who received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on Arm right on 30Dec2020 at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Asthma and Behcets syndrome. No Known allergies to medications, food, or other products. Concomitant medications included the patient received within 2 weeks of vaccination: Albuterol inhaler (Inhalation vapour, solution), Magnesium, ergocalciferol (VIT D), Ashwagandha. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced right eye and cheek is swollen, right sided headache and right sided neck, muscle spasm and tightness from 07Jan2021 07:00AM. No COVID prior vaccination. No COVID tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment was received for the adverse event included OTC ADVIL, PPI, Sudafed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered. Information on the lot/batch number has been requested.
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| 33 | 2021-01-13 | headache | Tinnitus RT ear and light headache |
| 33 | 2021-01-13 | dizziness |
Within seconds I felt an extreme hot sensation; dizziness; This is a spontaneous report from a conta...
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Within seconds I felt an extreme hot sensation; dizziness; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient not pregnant received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number unknown, via an unspecified route of administration on 08Jan2021 h 11: 00 at single dose for COVID-19 immunization. Medical history was reported as none. Patient had no known allergies and had no COVID prior vaccination. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient did not receive other concomitant medications within 2 weeks of vaccination. On 08Jan2021 patient experienced an extreme hot sensation and dizziness lasted a minute (within seconds I felt an extreme hot sensation and dizziness, as reported). No treatment administered for the events. Since the vaccination patient had not been tested for COVID-19. Patient recovered from both events on 08Jan2021. Information on the Lot/Batch number has been requested.
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| 33 | 2021-01-13 | chills, fever, sweating, headache, shortness of breath, dizziness, malaise |
about 10 hours after administration, I developed SOB, mild chest pain, hoarseness, and right sided w...
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about 10 hours after administration, I developed SOB, mild chest pain, hoarseness, and right sided wheezes. I self treated with albuterol (2 puffs) inhaler that I have on hand in case of environmental allergy triggers (I rarely have to use it- last use 3 years ago). The wheezing resolved and chest pain improved but the hoarseness remained. Over the next 2-3 hours I developed headache, malaise, mild dizziness, arthralgia, myalgia, and eventually fevers and chills (by 13 hours after vaccine administration). When fever reached 101 I self treated with naproxen 250mg. I slept for 4 hours and awoke diaphoretic, but the fever had resolved and I felt much better. However, I developed urticaria that started on my flexor surfaces of the elbows, hips, and knees, and spread to my adbomen, thighs, and face, with swelling about my right eye. I self treated with 25mg benadryl and itching and urticaria improved to the point that I was able to sleep. When I awoke the next morning my symptoms had largely resolved with the exception of mild headache, body aches, hoarseness, slight chest tightness, and mild residual swelling of the right eyelid.
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| 33 | 2021-01-13 | malaise, chills, fever |
body ache; High grade fever (102); rigors; malaise; This is a spontaneous report from a Non-contacta...
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body ache; High grade fever (102); rigors; malaise; This is a spontaneous report from a Non-contactable Physician. A 34 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 05Jan2021 12:00 at the second single dose (lot number EL0142), via an unspecified route of administration on 15Dec2020 17:00 at the first single dose (lot number EK5730) for covid-19 immunisation. Vaccination location was Left arm. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced body ache, high grade fever (102), rigors, malaise on 05Jan2021 18:00. The patient did not receive any treatment for the events. The outcome of events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.
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| 33 | 2021-01-13 | head discomfort, headache |
body is cold; Occasionally some nauseous sensation but didn't throw up; Eyes feel so tired; hard to ...
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body is cold; Occasionally some nauseous sensation but didn't throw up; Eyes feel so tired; hard to concentrate; it bother my sleep; first dose on 19Dec2020, second dose on 06Jan2021; heaviness in the head when I woke up next day; some hot/spicy sensation around eyes area; didn't even have good appetite during lunch time on day 2; sever headache started at night of day one; This is a spontaneous report from a contactable Other HCP (patient). A 33-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EK9231), on 06Jan2021 14:30 via an unspecified route of administration in the left arm at single dose COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730) on 19Dec2020 09:45 in the left arm at single dose for COVID-19 immunisation. On 06Jan2021 at 23:00, started at night of day one, the patient experienced severe headache. The patient experienced also heaviness in the head when she woke up next day (07Jan2021) and had some hot/spicy sensation around eyes area (07Jan2021). The patient needed to take paracetamol (TYLENOL) to get some relieve and she did not even have good appetite during lunch time on day 2 (07Jan2021). On unspecified date the patient had no fever and her body was cold; occasionally some nauseous sensation but didn't throw up. Eyes feel so tired and hard to concentrate. Hopefully those symptoms go away soon as days pass since it bothered patient sleep. The patient had a doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. The patient took also guaifenesin (MUCINEX). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
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| 33 | 2021-01-13 | fatigue |
feeling fatigue; she has swollen lymph nodes in the right axillary area and the right breast; swolle...
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feeling fatigue; she has swollen lymph nodes in the right axillary area and the right breast; swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore; swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore; had a slightly elevated Hemoglobin; soreness in the left arm where she received injection; This is a spontaneous report from a contactable consumer. A 33-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK9231) in the left arm via an unspecified route of administration on 29Dec2020 08:00 at single dose for covid-19 immunisation. Medical history included supraventricular tachycardia from 2015 (It is under control currently. She was diagnosed in 2015 and she had ablation right away). The patient got the flu vaccine which was required by her workplace was Oct2020. She had flu symptoms, sore throat, and a little headache. Concomitant medication included colecalciferol (VITAMIN D) from 2020 and ongoing. The main side effects was soreness in the left arm where she received injection for one to two days. She couldn't lift her arm. Soreness in the left arm started around 17:00 on 29Dec2020. The patient had a physical on Monday (04Jan2021) and everything was perfectly fine. When she did all the blood work and everything was fine. She had a CBC count on Monday (04Jan2021) and the white blood count was normal. She had a slightly elevated Hemoglobin. All other test like calcium and blood sugar were all normal. Swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore. Then on 06Jan2021 when she looked in the mirror she flexed her arm and saw a line around the breast and it was a little swollen. She got the injection in the left arm. She clarified that she has swollen lymph nodes in the right axillary area and the right breast. There is no swelling on the left. The patient stated today (08Jan2021) the swollen lymph nodes and breast is worse. She is feeling fatigue and can't palpate nodes in breast or axillary area. When she lifts her arm there is a line on the right breast. The outcome of Swollen lymph nodes was not recovered; of other events was unknown.
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| 33 | 2021-01-13 | headache | symptoms started on 01/13/21 : tinnitus in rt ear and light headache |
| 33 | 2021-01-13 | dizziness, fever, headache |
tactile overstimulation?(having clothing or a blanket hurt and irritated my skin); Extreme headache;...
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tactile overstimulation?(having clothing or a blanket hurt and irritated my skin); Extreme headache; blurred vision at long distances; lightheadedness; occasional off balance; diarrhea; low grade fever; body aches; This is a spontaneous report from a contactable Nurse. This 33-year-old female Nurse (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), intramuscular on 05Jan2021 06:45 AM at single dose on left arm for COVID-19 immunisation. Medical history included hypertension (HTN), depression and anxiety. No known allergies. Concomitant medication included quetiapine fumarate (SEROQUEL), metoprolol, hydrochlorothiazide, lithium, alprazolam (XANAX), lamotrigine (LAMICTAL), folic acid / iron (PRENATAL), multivitamins [vitamins nos] (MULTIVITAMINS), melatonin, ibuprofen, paracetamol (TYLENOL). The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: Eh9899), intramuscular on 15Dec2020 07:30 AM on left arm for COVID-19 immunisation. The patient extreme headache with blurred vision at long distances (blurred vision resolved after 24 hours) lightheaded ness/occasional off balance, diarrhea, low grade fever, body aches, tactile overstimulation (having clothing or a blanket hurt and irritated her skin) on 06Jan2021 01:00 AM. No treatment was received for the events. The outcome of the event blurred vision at long distances was recovered in Jan2021. The outcome of other event was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 33 | 2021-01-14 | shortness of breath, chills, cough, throat irritation |
12/20: 10 mins after the injection my arm started hurting so I was moving it around and suddenly a f...
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12/20: 10 mins after the injection my arm started hurting so I was moving it around and suddenly a felt a tickle in my throat, swallowed and felt like I swallowed the wrong way and was coughing to the point of feeling like I was going to vomit. Per everyone around I was bright red and I looked weird. The ER nurse said my heart rate was 125 and my systolic BP was elevated at 130s (normally in the 110s). After sitting for 45 mins heart rate was back to 60s. Still felt like I was in a fog but felt ok. Once I walked to my car I felt alot of nausea again and was on and off the rest of the day. In the middle of the night I woke up short of breath laying on my back had to lay on my side. 12/21. I was moving pavers and got short of breath. Checked my heart rate and it was 100. O2 sat was 99%. If I sat and didn't move I was fine as soon as I started moving it started again. Also felt nauseating all day. I was having a hard time concentrating and my husband was getting frustrated that I wasn't understanding what he was saying. My left arm hurt really bad all day 12/22 By the afternoon felt more normal except my arm still hurting really bad. 12/26 was shoveling dirty and suddenly my arm where I got the injection started hurts and I got very nauseated again. On 12/29 the cdc called me because I did the vsafe program. They were wondering if I was actually going to get the second vaccination because they said my reaction is a severe reaction. 12/30 my arm started itching had chills and temp right after 1/1 rapid test was negative for covid 1/2 pcr was negative
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| 33 | 2021-01-14 | malaise, chills, somnolence, fever, fatigue |
Chills; fatigue; muscle aches so bad it made me cry; muscle aches so bad it made me cry; pain everyw...
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Chills; fatigue; muscle aches so bad it made me cry; muscle aches so bad it made me cry; pain everywhere even clothes against my skin hurt/it was all I could do to physically get to bed, which hurt with every step; temp of 99.7; malaise; profound sleepiness; Arm pain at injection site; Arm pain at injection site; This is a spontaneous report from a contactable Physician reported for herself. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at Left arm on 08Jan2021 09:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historic vaccine included the first dose of BNT162B2 on 18Dec2020 08:00 AM intramuscular at Left arm for covid-19 immunization. The patient experienced Chills, fatigue, muscle aches so bad it made her cry, pain everywhere even clothes against her skin hurt, temperature of 99.7, malaise, profound sleepiness, and it was all she could do to physically get to bed, which hurt with every step. Arm pain at injection site for 2 days now, could not sleep on that side, adverse event start date was provided as 08Jan2021 09:00 AM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 33 | 2021-01-14 | chills, fatigue, throat pain, respiratory tract congestion, cough | Fatigue, chills, body aches, sore throat, cough, congestion |
| 33 | 2021-01-14 | chills |
I had experienced body aches, and chills on the day of the vaccine. On Monday following the vaccine ...
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I had experienced body aches, and chills on the day of the vaccine. On Monday following the vaccine I had hives all Over my body which were treated with Benadryl. On Tuesday the hives persisted but treated during the day with Benadryl, at about 10:30pm the hives started to show on my face, my lips got swollen, and I felt like a pit in my throat That was stuck. I went to the ED and I was treated with IV Benadryl, IV Pepcid, and IV Solumedrol. I left the ED upon signs of improvement and was given prescriptions for Epi pen and steroids for 4 days.
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| 33 | 2021-01-14 | headache, weakness |
Immediate headache and pressure at base of skull into neck. L Arm stiffness/weakness/tenderness that...
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Immediate headache and pressure at base of skull into neck. L Arm stiffness/weakness/tenderness that goes down into my hand and left side neck tightness/stiffness (muscular), upper back & B/L shoulder aching and muscular stiffness. Feels almost like a dull ?electrical shock? feeling across my upper back and down my left arm. Joint pain on the L side of my body-elbow, hip and knee. All symptoms continue into the night on day 2 after the vaccine (past 24 hrs after receiving).
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| 33 | 2021-01-14 | fever, headache |
Intense Headache, neck ache, body ache, fever. Missed work (01/14/21) neck ache, body ache, moderate...
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Intense Headache, neck ache, body ache, fever. Missed work (01/14/21) neck ache, body ache, moderate headache (01/15/21).
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| 33 | 2021-01-14 | fatigue, fever, cough, chills, shortness of breath |
On Sun 12/27 around 12pm I had left arm tenderness and I was fatigued and then at 5pm I had a fever ...
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On Sun 12/27 around 12pm I had left arm tenderness and I was fatigued and then at 5pm I had a fever starting at 99.5 and by 11pm 103.5 I had body aches chills, rigers, fever did not break with tylenol or advil . I had the fever until Monday afternoon and it broke for a few hours and came back and did not budge from 101. I called occupational health and asked questions about my fever, monday night at 8pm I had a bad dry cough and SOB and chest tightness and sinus congestion, no sneezing or runny nose, still with a fever. I called occupational health again and they said to come in to get covid tested and results were positive Tuesday 29th AM. On Thursday I started taking medicine: 5 day course of singulair, slow vent albuterol prn teflex antibiotic and calcium, Zinc and Vitamin D. The fever started to break around Monday the1st to the 4th around 99 to 100 . The 4th I lost sense of taste and smell and Monday the 28, 2020 I had neuromuscular pain in stiffness in legs and I had trouble walking and when fever got lower I realized I was having pain in my feet and hips. I think the infection triggered the unknown neuromuscular condition. I was supposed to go to work the 11th but since I was still having leg issues and my leave was extended one more week. I do not believe these reactions were due to the vaccine I think it was just a coincidence I contracted COVID prior to getting the vaccine
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| 33 | 2021-01-14 | fever, headache, chills, dizziness |
One day after receiving second dose of Pfizer COVID-19 vaccine, patient reported chills, muscle ache...
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One day after receiving second dose of Pfizer COVID-19 vaccine, patient reported chills, muscle aches, headache, diarrhea, breast tenderness/uterine cramping, dizziness. Patient was tested for COVID-19 and was negative. Patient is not currently breastfeeding, pregnant, or menstruating. Patient self-medicated with acetaminophen and ibuprofen. Fever and diarrhea resolved later on 1/8.
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| 33 | 2021-01-14 | skin warm |
Severe urticaria, papular rash. Full body itchy, warm, red rash. Prescribed Tagamet,Benadryl and Pre...
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Severe urticaria, papular rash. Full body itchy, warm, red rash. Prescribed Tagamet,Benadryl and Prednisone 2 days after vaccination. Rash has only been getting worse each day.
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| 33 | 2021-01-14 | nasal congestion, fever, headache, throat pain | Sore throat, fever, congestion, headache, muscle ache |
| 33 | 2021-01-14 | chills, fever, malaise, headache, fatigue |
Symptoms ? EE reports she woke up on 1/14 with body aches, chills and fatigue. + fever (Tmax 100.1)...
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Symptoms ? EE reports she woke up on 1/14 with body aches, chills and fatigue. + fever (Tmax 100.1) and advil taken. EE reports she called off of work yesterday due to feeling ill. EE reports today improvement in symptoms but still with mild HA and fatigue. Temp 99.4 today, advil taken at 13:15.? Last day of work and shift ? today Home remedies? - rest and Advil Any improvement? - yes Recommendation? EE encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. EE reports she called off work yesterday and heading to work at time of call. EE educated on Illness in the Workplace Policy and to notify her manager if she needs to leave work and go home. EE verbalized back understanding and denied further questions at this time.
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| 33 | 2021-01-14 | malaise, fever, chills, fatigue, headache |
Symptoms ? EE reports she woke up on 1/14 with body aches, chills and fatigue. + fever (Tmax 100.1)...
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Symptoms ? EE reports she woke up on 1/14 with body aches, chills and fatigue. + fever (Tmax 100.1) and advil taken. EE reports she called off of work yesterday due to feeling ill. EE reports today improvement in symptoms but still with mild HA and fatigue. Temp 99.4 today, advil taken at 13:15.? Last day of work and shift ? today Home remedies? - rest and Advil Any improvement? - yes Recommendation? EE encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. EE reports she called off work yesterday and heading to work at time of call. EE educated on TCH Illness in the Workplace Policy and to notify her manager if she needs to leave work and go home. EE verbalized back understanding and denied further questions at this time.
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| 33 | 2021-01-14 | shortness of breath |
Systemic: Nausea, Systemic: Vomiting, Systemic: tongue/face swelling, shortness of breath; symptoms ...
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Systemic: Nausea, Systemic: Vomiting, Systemic: tongue/face swelling, shortness of breath; symptoms lasted 1 day
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| 33 | 2021-01-14 | headache |
Tachycardia, chest tightness, headache starting approximately 10 days after vaccination. Started on ...
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Tachycardia, chest tightness, headache starting approximately 10 days after vaccination. Started on 24 hour holter monitor x14 days. Saw Cardiology had an ECHO and started on metoprolol
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| 33 | 2021-01-14 | dizziness |
Went to stand up after 15 mins of observation. Felt flush, hot, dizzy. Heartrate was irregular per o...
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Went to stand up after 15 mins of observation. Felt flush, hot, dizzy. Heartrate was irregular per observation RN who was checking pulse. Went to ED, EKG and bloodwork normal, released home.
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| 33 | 2021-01-14 | dizziness |
Went to stand up after 15 mins of observation. Felt flush, hot, dizzy. Heartrate was irregular per o...
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Went to stand up after 15 mins of observation. Felt flush, hot, dizzy. Heartrate was irregular per observation RN who was checking pulse. Went to ED, EKG and bloodwork normal. Patient released home.
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| 33 | 2021-01-14 | headache, fever, head discomfort, fatigue |
Within one hour of shot: Mild facial tingles especially surrounding L eye, mild fatigue Within a fe...
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Within one hour of shot: Mild facial tingles especially surrounding L eye, mild fatigue Within a few hours: increased fatigue, mild ?brain fog? with some word finding difficulty, mild pressure behind eyes 3am, ~16 hours post: mild to moderate body aches, low grade fever 98-99 degrees 8am, ~21 hours post: mild body aches, back to normal temp, continued fatigue, TERRIBLE headache! 7-8/10 pain for about 10 hours. Throbbing in temples, eye pressure, pressure on top of head, worsened when I would bend over. Did not take any medication, worried it would impact immune response. Drank a lot of water, slept, did some sled massage, and gentle yoga/stretches. By that evening pain level had dropped down to about a 4. Woke up the next morning with 2-3 level pain, was able to go to work without being distracted by pain. Still felt more pressure behind eyes and top of head when I bent over. Next day all symptoms resolved, except very minor tenderness at injection site only when palpated.
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| 33 | 2021-01-14 | fever, cough, chills, throat pain |
fever and chills the following day, then progressive sore throat, cough and hoarseness that has last...
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fever and chills the following day, then progressive sore throat, cough and hoarseness that has lasted since
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| 33 | 2021-01-14 | fever | fever of 100.9; generalized body aches |
| 33 | 2021-01-14 | shortness of breath |
had a metallic taste; turned to swollen tongue; hives around chest and neck; difficult to breathe; t...
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had a metallic taste; turned to swollen tongue; hives around chest and neck; difficult to breathe; tachycardia; This is a spontaneous report from a contactable other HCP (Patient). A 33-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL 3248), via an unspecified route of administration at right arm on 07Jan2021 16:15 at single dose for covid-19 immunization. Vaccine was administered at hospital. Known allergies included cyclobenzaprine and dairy latex. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 10 mg, gabapentin 300 mg, venlafaxine 150 mg. No other vaccine in four weeks. Three minutes after vaccination the patient had a metallic taste, turned to swollen tongue, hives around chest and neck, difficult to breathe, and tachycardia on 07Jan2021 16:18. The events resulted in Emergency room/department or urgent care. Treatment received included Epinephrine, methylprednisolone sodium succinate (SOLU-ME dork) and famotidine (PEPCID) also diphenhydramine HCl (BENADRYL). The outcome of the events was unknown.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for events metallic taste, swollen tongue, hives, difficulty breathing and tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 33 | 2021-01-15 | shortness of breath |
ABOUT 20 MINUTES AFTER INJECTION BEGAN TO FEEL ITCHING ALL OVER BODY, SHORTNESS OF BREATH, FLUSHING,...
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ABOUT 20 MINUTES AFTER INJECTION BEGAN TO FEEL ITCHING ALL OVER BODY, SHORTNESS OF BREATH, FLUSHING, HIVES AND NAUSEA - TAKEN TO ER FOR OBSERVATION AND ADMINISTERED DIPHENEHYDRAMINE - RECOVERED AND DISCHARGED
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| 33 | 2021-01-15 | headache, fatigue | Headache, Myalgia, NauseaVomiting, Tachycardia, Fatigue Narrative: |
| 33 | 2021-01-15 | chills, headache, fever |
On the day of the vaccine 01/13/21 I developed a fever, chills, muscle aches, headaches, and swollen...
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On the day of the vaccine 01/13/21 I developed a fever, chills, muscle aches, headaches, and swollen lymph nodes in my left armpit and and left neck. I still have these symptoms three days later.
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| 33 | 2021-01-15 | runny nose, chills | Rhinorrhea full body aches and pains of the long bones, chills. |
| 33 | 2021-01-15 | throat irritation |
dry itchy throat starting within 20 minutes. waited until approx 330 to take a benadryl as it was ha...
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dry itchy throat starting within 20 minutes. waited until approx 330 to take a benadryl as it was harder to swallow, an hour and a half later hives began to show at approx 530 went to urgent care. was prescribed steroids. took benadryl over night to keep from iching and started steroids this morning. no more hives have showed since going to urgent care.
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| 33 | 2021-01-16 | chills, fever |
Low-grade fever, body aches, chills and injection site soreness - symptoms began 8-10 hours after va...
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Low-grade fever, body aches, chills and injection site soreness - symptoms began 8-10 hours after vaccine was administered and lasted for about 18 hours
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| 33 | 2021-01-16 | headache, shortness of breath |
Patient reported trouble breathing, tachycardia, tingling in face and lips, flushing on the day of v...
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Patient reported trouble breathing, tachycardia, tingling in face and lips, flushing on the day of vaccination. That day she took 25 mg of Benadryl, then another 25 mg of Benadryl 5 minutes later. Her symptoms got slightly better, but she had to take another 25 mg in the evening. She reports having a headache, muscle aches and pains for 3 days after vaccination.
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| 33 | 2021-01-16 | throat irritation |
Tingling and burning sensation on tongue, back of throat and left side of face when awoke after a li...
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Tingling and burning sensation on tongue, back of throat and left side of face when awoke after a little over 48 hours post vaccination. I took Benadryl which took the edge a little off of the sensation. The discomfort lasted throughout the day.
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| 33 | 2021-01-17 | dizziness | 1/6/21 dizzy, nausea, photophobia- 45 minutes after vaccine |
| 33 | 2021-01-17 | headache, chills, fever |
Breast feeding/first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; She was also breast feeding; ...
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Breast feeding/first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; She was also breast feeding; first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; Fever of 101.7/ temp is still a little elevated at 99.5; full body aches; Chills; Headache; Breast feeding and experienced painful let down; This is a spontaneous report from a non-contactable nurse (patient) reported for herself. This Nurse reported information for both herself and her baby. This is a mother report. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL1283) via an unspecified route of administration on 11Jan2021 07:30 at single dose for COVID-19 immunization. The patient received the first dose on 24Dec2020 14:30 at age of 33 years old at single dose for COVID-19 immunization, and only had a sore arm and maybe fatigue. Medical history included ongoing breast feeding, asthma, Anaphylaxis to tree nuts. Concomitant medication included bifidobacterium lactis (PROBIOTIC) and prenatal multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever of 101.7, full body aches, chills, headache. She was also breast feeding and experienced painful let down at the time (she did not have mastitis). She had all these symptoms on 11Jan2021 16 hrs after receiving second dose. Now at 24 hours all symptoms have resolved except her temp is still a little elevated at 99.5. No treatment was received for the adverse event. Events outcome of full body aches, chills, headache, painful let down at the time (breast feeding) was recovered, for fever was recovering, while for others was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027460 Mother/Baby case
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| 33 | 2021-01-17 | chills, fatigue, headache, fever | Fatigue, chills, mild fever, headache, injection site pain, swollen lymph node |
| 33 | 2021-01-17 | dizziness |
Pt is 33 yo female with h/o multiple drug allergies , including allergy to benadryl. She has receive...
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Pt is 33 yo female with h/o multiple drug allergies , including allergy to benadryl. She has received first dose of COVID vaccine made by Phfizer at 3:45. She reports about 10 minutes after the vaccination she started feeling tingling in her lips, throat and prickly sensation on her chest and feeling "off". Felt dizzy, developed small hives on her chest. She was attended to immediately at the vaccine site and our team was called to white code. Pt was sitting on the floor, alert , breathing comfortably. Her BP was 151/84, HR 90, O2 Sats 100%. Her lungs were clear the whole time, no wheezing, no difficulty swallowing or talking. Patient received 125 mg of IV solumedrol and 20 mg of pepcid in vaccination room, she felt the same, still breathing comfotably, speaking full sentences, hives faiding away. She was transported to Urgent Care clinic on wheelchair. Pt kept her EpiPen by her site the whole time but refused to used it, states she is afraid to use it and wants to hold off or get it in ER if necessary. About 16:30 patient reported her tingling, prickly sensation In her chest is getting worse, developed sensation of lump in her throat, able to swallow and breath without problems, lungs exam clear. Again recommended to give Epipen but patient again refused as she feels very anxious about getting new medicine. She was able to speak full sentences and breathing well, O2 Sats 100% the whole time, she repetitively refused EpiPen. EMS called and patient transported to ER, ER notified. Pt left in stable condition.
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| 33 | 2021-01-17 | fatigue |
Sore arm; Fatigue; Patient also breast feeding; Patient also breast feeding; This is a spontaneous r...
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Sore arm; Fatigue; Patient also breast feeding; Patient also breast feeding; This is a spontaneous report from a non-contactable nurse. This patient reported information for both herself and her baby. This is a mother report. A 33-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Dec2020 14:30 at single dose for COVID-19 immunization. Medical history included ongoing breast feeding, asthma, Anaphylaxis to tree nuts. Concomitant medication included bifidobacterium lactis (PROBIOTIC) and prenatal multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. For the first dose the patient only had a sore arm and maybe fatigue. No treatment received for the adverse event. She was also breast feeding. Events outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027460 Mother/Baby case
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| 33 | 2021-01-17 | chills |
minor side effect: night of injection had vivid dream, and 2nd night after injection had another viv...
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minor side effect: night of injection had vivid dream, and 2nd night after injection had another vivid dream when I do not typically have dreams minor side effect of some chills 13 hours after injection that slight worsened, persisting until 36 hours after injection (resolved 1.5 days after injection) moderate pain at site of injection, onset 5 hours after injection and lasting until 2.5 days after injection
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| 33 | 2021-01-19 | shortness of breath, malaise, sweating |
Approx. 5 min post administration recipient complained of not feeling well. On exam patient was bra...
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Approx. 5 min post administration recipient complained of not feeling well. On exam patient was bradycardic, diaphoretic, pale and altered. Patient appearance worsened, and level of responsiveness continued to decrease. Patient was hot and indicated difficulty breathing, and nodded in confirmation when asked if her throat felt tight. Patient given 0.3mg epinephrine IM via autoinjector in the right thigh. Patient condition improved rapidly and regained awareness. Patient transported to ER for ekg and monioting, discharged without incident.
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| 33 | 2021-01-19 | chills, headache |
Body aches, chills, headache. Treated with Tylenol for 24 hours and symptoms have started to subsid...
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Body aches, chills, headache. Treated with Tylenol for 24 hours and symptoms have started to subside
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| 33 | 2021-01-19 | headache, chills, malaise, fever | Chills, Malaise, Headache, Fever (101.7), myalgias |
| 33 | 2021-01-19 | chills, headache, fever | FEVER, CHILLS, BODY ACHES, HEADACHE |
| 33 | 2021-01-19 | chills | FROM 1/8 3AM TO 1/8 7PM: CHILLS AND BODY ACHES. TOOK IBUPROFEN EVERY 4- 6 HRS. |
| 33 | 2021-01-19 | fatigue, chills | Fatigue, body aches, chills began 1/19/21 @ about noon, following 2nd dose |
| 33 | 2021-01-19 | weakness, night sweats, dizziness, fever |
Fever night sweats; Fever night sweats; severe anxiety from 12 am -5 am, anxiety subsiding; weakness...
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Fever night sweats; Fever night sweats; severe anxiety from 12 am -5 am, anxiety subsiding; weakness; muscle pain; Dizziness; Now having swelling lymph nodes under left arm; pain down entirety of the arm; This is a spontaneous report from a contactable other health care rofessional (HCP) (Patient). A 33-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Intramuscular Left arm on 07Jan2021 02:00 PM at a single dose for COVID-19 immunization, Lot number: unknown. Medical history was reported as none. Patient had no known allergies. Concomitant medications were not provided. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 02:00 PM Intramuscular Left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if patient received any other vaccine within four weeks prior to the vaccination. Patient had not been tested for COVID-19 post vaccination. The patient received purified protein derivative (PPD) within two weeks prior to the vaccination on unknown date in Jan2021 (reported as last week), unknown results. On 08Jan2021 12:00 AM patient experienced fever night sweats, severe anxiety from 12 am -5 am, anxiety subsiding, residual fever, weakness, muscle pain and dizziness for the next 48 hours. Now having swelling lymph nodes under left arm and pain down entirety of the arm. No treatment received for the events. At the time of the report anxiety was recovering and patient had not recovered from the other mentioned events. Information on the Lot/Batch number has been requested.
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| 33 | 2021-01-19 | sweating, fever, fatigue |
Full body myalgia; fatigue; diaphoresis; fever; Left upper arm edema and pain/tenderness.; Left uppe...
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Full body myalgia; fatigue; diaphoresis; fever; Left upper arm edema and pain/tenderness.; Left upper arm edema and pain/tenderness.; This is a spontaneous report from a contactable nurse reported for herself. A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EK9231 via an unspecified route of administration on 09Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation. Vaccine location: left arm, dose number 2, facility type vaccine: hospital. Historical Vaccine bnt162b2 (BNT162B2) Lot number EL0140 on 21Dec2020 14:45 vaccine location left arm, dose number 1, facility type vaccine: hospital. The patient medical history was not reported. There were no concomitant medications. The patient experienced left upper arm edema and pain/tenderness onset within 3 hours of receiving the 2nd dose of the vaccine. In addition: full body myalgia, fatigue, diaphoresis and fever. Symptom duration was about 12 hours. Symptoms were relieve with Tylenol and Ibuprofen. The action taken was not applicable.
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| 33 | 2021-01-19 | headache | Headache and nausea at 0730 on 1/20. Had to leave work. |
| 33 | 2021-01-19 | headache | I had extreme headache and nausea for 24 hours. |
| 33 | 2021-01-19 | fatigue, fever, headache | Low grade temp 100.5, facial rash, swollen lymph nodes, fatigue, headache that lasted 6 days |
| 33 | 2021-01-19 | chills, weakness, fever, dizziness |
Onset 10-12 hours after dose on 1/18/21 Body aches, chills awakening from sleep. Fever 100.5 after a...
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Onset 10-12 hours after dose on 1/18/21 Body aches, chills awakening from sleep. Fever 100.5 after acetaminophen. Weakness, dizziness, mild Pre-syncope, nausea. Persisted through the night and early morning and gradually improving the next day. 24 hours after symptom onset, temp was still 99.5. Much improved with residual generalize muscle soreness upon awakening on 1/20/21
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| 33 | 2021-01-19 | fever |
Rash temp of 101; Rash temp of 101; body aches; This is a spontaneous report from a contactable othe...
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Rash temp of 101; Rash temp of 101; body aches; This is a spontaneous report from a contactable other health professional. This report involves a 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 09Jan2021 10:45 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown dose for covid-19 immunisation. On 10Jan2021, the patient experienced rash, temp of 101, body aches with outcome of recovering. The vaccine was administered at Hospital Facility. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Information on the Lot/Batch number has been requested.
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| 33 | 2021-01-19 | headache |
Received vaccine at 0900. By 1900 employee was having body aches and headache. Symptoms improving...
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Received vaccine at 0900. By 1900 employee was having body aches and headache. Symptoms improving this afternoon (1/20/21).
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| 33 | 2021-01-19 | sweating, malaise |
approx. 5 min after receiving vaccine patient complained of not feeling well. on exam patient was br...
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approx. 5 min after receiving vaccine patient complained of not feeling well. on exam patient was bradycardic at 56, diaphoretic, hot, and altered. Patient continued to deteriorate in mental status. Patient indicated yes by nodding and clutching throat to airway constriction. Patient given .3mg epi via auto injector in the left thigh. Patient status improved markedly after adminstration. Patient taken to Er for observation and EKG. Patient was discharged without incident.
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| 33 | 2021-01-20 | dizziness |
G2P1; 19 weeks pregnant; employee felt dizzy and lightheaded after receiving her vaccine. employee ...
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G2P1; 19 weeks pregnant; employee felt dizzy and lightheaded after receiving her vaccine. employee given water and Cheez-Its and reported feeling much better.
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| 33 | 2021-01-21 | chills |
Body aches, chills, possible fever (temperature not actually taken) On night of administration lasti...
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Body aches, chills, possible fever (temperature not actually taken) On night of administration lasting through second day, or day after vaccination administration
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| 33 | 2021-01-21 | dizziness, shortness of breath |
Day after vaccine I began to have tachycardia upon standing and walking. Heart rates are in the 140-...
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Day after vaccine I began to have tachycardia upon standing and walking. Heart rates are in the 140-170s when walking a normal pace. Resting heart rate is much higher than normal at around 100. When climbing stairs, heart rate gets into the high 170s. Shortness of breath and dizziness accompany standing, walking and climbing stairs. These symptoms still persist - have been ongoing from 11/12/21 - 11/22/21.
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| 33 | 2021-01-21 | headache, fever |
SWOLLEN LYMPH NODE IN R ARMPIT (MODERATE, ONGOING) FEVER (MILD, REDUCED WITH TYLENOL) HEADACHE (MODE...
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SWOLLEN LYMPH NODE IN R ARMPIT (MODERATE, ONGOING) FEVER (MILD, REDUCED WITH TYLENOL) HEADACHE (MODERATE, ONGOING) STOMACH UPSET (MILD, INTERMITTENT)
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| 33 | 2021-01-21 | nasopharyngitis | Tongue was numb for 3 hours. Then base of tongue and throat were tingling and cold. |
| 33 | 2021-01-24 | fever, cough, chills |
After vaccination - I was noticing eczema flare up - but not bad; and then 27th, I got blisters on ...
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After vaccination - I was noticing eczema flare up - but not bad; and then 27th, I got blisters on left cheek likes pins and needles poking my face; next day the blisters popped and created crater on my skin and area was getting bigger and it was oozing and I felt that stinging poking on that affected area. Next day after that, I went to my dermatologist for a consultation and he said it was Herpes Simplex. Along with that, 2 days after the blisters started appearing on my face, before I went to my dr's office - was having 101. fever, chills, body aches , and severe cough with vomiting and not able and so I got tested the day I went to my Dr. and it was a negative COVID test. Treatment: Antiviral medication for one week; Topical ointment: Bacteralban ointment; I still have the face color with the Herpes was.
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| 33 | 2021-01-24 | chills, influenza like illness, lethargy, body temperature increased, fatigue, fever |
At 8pm I felt tried and went to bed- starting at 9pm I began having shivers and could not get warm. ...
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At 8pm I felt tried and went to bed- starting at 9pm I began having shivers and could not get warm. My temperature was 102, then my fever rose to 104.5 for most of the night. I did not sleep because my body was shaking and shivering. My body ached all over, especially my lower back. It felt like a very bad flu. My fever continued onto the next day and stayed around 103.7. I slept most of the day- had to call out of work. Tuesday morning my fever was gone and I went to work then went home because my fever spiked again to 101 about mid day. I slept all day and took Tylenol. By Wednesday my Fever was gone but I was still very lethargic. Thursday I felt fine.
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| 33 | 2021-01-24 | chills | Body aches, chills |
| 33 | 2021-01-24 | fever, shortness of breath |
Developed severe body aches, chest pain and shortness of breath. High fever, reaching 103.3. Fever a...
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Developed severe body aches, chest pain and shortness of breath. High fever, reaching 103.3. Fever and symptoms lasted 72 hours with little relief with Tylenol or Ibuprofen. I called into PCP and he stated that because I recently had COVID, my immune response to the vaccine was exaggerated.
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| 33 | 2021-01-24 | headache |
Myalgias; Arthralgias; Pain at injection site; Headache; This is a spontaneous report from a contact...
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Myalgias; Arthralgias; Pain at injection site; Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 33-year-old female patient received BNT162B2 (lot number: EL0140), via an unspecified route of administration in left arm on 29Dec2020 08:00 at single dose for COVID-19 immunization. Medical history included celiacs disease, dermatitis herpetiformis, melanoma in situ, known allergies: Gluten, and COVID prior vaccination. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). Patient experienced myalgias, arthralgias, headache, and pain at injection site on 30Dec2020 00:00. No treatment was received for these events. Outcome of the events was not resolved.
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| 33 | 2021-01-24 | headache, chills | Nausea, body aches, chills, headache |
| 33 | 2021-01-24 | chills, dizziness, headache, fever |
Pain at injection site, Dizziness, fever, chills, all over muscle pain, Headache, left armpit lymph ...
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Pain at injection site, Dizziness, fever, chills, all over muscle pain, Headache, left armpit lymph node swelling and soreness
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| 33 | 2021-01-24 | headache, fatigue, fever | muscle aches, headache, fever 100.4, fatigue |
| 33 | 2021-01-24 | dizziness |
passed out briefly; a fruity taste in her mouth; turned "Beet red" on her neck/face; have an episode...
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passed out briefly; a fruity taste in her mouth; turned "Beet red" on her neck/face; have an episode of hypertension; feeling hot; was "swaying"; had menstrual like cramps that radiated from her abdomen to her entire body; had menstrual like cramps that radiated from her abdomen to her entire body; This is a spontaneous report from a contactable pharmacist. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 13Jan2021 at the first single dose for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. Within in minutes of receiving the vaccine on 13Jan2021, the patient reported a fruity taste in her mouth, turned "Beet red" on her neck/face, and passed out briefly. When she regained consciousness, she was given Benadryl, and also was reported to have an episode of hypertension. She reported feeling hot and was "swaying" and had menstrual like cramps that radiated from her abdomen to her entire body. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the event "passed out briefly". The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021027150 same reporter/drug, similar event, different patient
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| 33 | 2021-01-25 | fever, chills, fatigue, headache, sweating |
Approx 8 hrs after injection i developed sore arm. After that my entire body began to ache, mild at ...
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Approx 8 hrs after injection i developed sore arm. After that my entire body began to ache, mild at first and then like I had been hit by a truck. Around 10 pm I developed chills and the feeling I couldn't get warm and felt exhausted. Sore body and chills lasted all night, I developed a fever sometime in the night and when checked was 101.9. Took 2 doses of tylenol to bring it down to 99. Ive been sweating profusely, severe headache, accelerated heart rate reaching 100 bpm at complete rest along with feeling exhaustedand body aches that lasted all day and into the night. It is now 930 am on the 26th and I feel better. Still sweating and body aches mildly with some tiredness.
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| 33 | 2021-01-25 | headache | Body felt on fire Headache and severe Joint pain |
| 33 | 2021-01-25 | fever, headache, chills |
Chills; Fevers; minor body aches/severe body aches; small headache/severe headaches; This is a spont...
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Chills; Fevers; minor body aches/severe body aches; small headache/severe headaches; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the left arm on 12Jan2021 10:30 at a single dose for COVID-19 immunization. The patient's medical history included sub clinical hyperthyroidism and diagnosed with COVID prior to vaccination. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in the left arm on 21Dec2020 11:45 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. On 12Jan2021 20:00, the patient experienced minor body aches and a small headache. She went to bed and woke up at approx. 13Jan2021 00:15 with severe body aches, severe headaches, chills, and fevers. Therapeutic measures were taken as a result of the adverse events and included treatment with ibuprofen and diphenhydramine (BENADRYL). Outcome of the events was not recovered.
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| 33 | 2021-01-25 | dizziness, headache, chills, dehydration |
For her feeling like she was going to pass out, patient states that she was probably dehydrated; Rig...
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For her feeling like she was going to pass out, patient states that she was probably dehydrated; Right sided Neck Pain and Right sided armpit pain; Right sided Neck Pain and Right sided armpit pain; right side neck swelling; Felt like going to pass out; Felt light headed like she was going to pass out; Nausea; Vomiting; Upset stomach; Body chills and aches; Body chills and aches; Headache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: 31Mar2021) solution for injection, via an unspecified route of administration on right arm on 11Jan2021 at a single dose for Covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient was not pregnant. Patient reported she got the first dose on 20Dec2020 and on an unknown date in Dec2020, she experienced right side neck pain, right side armpit pain, arm pain where she received the vaccine on the right side, right neck swelling, tenderness, and lymph node thing. Patient reported that on 11Jan2021, she got the second dose at 9AM and by 5-6 PM she felt the symptoms. Then by 7:30PM felt terrible and had to have her sister come get her, she felt like she was going to pass out. She experienced the nausea before 7:30PM on 11Jan2021. The vomiting happened on 11Jan2021 at night 12 hours after the vaccine, she vomited the next day also around 10 in the morning on 12Jan2021. The upset stomach started 11Jan2021. Patient confirmed that she did not actually pass out but she felt light headed like she was going to pass out, it started on 11Jan2021 and went into 12Jan2021 she was just light headed and not well. The body chills aches started 11Jan2021 around the 5-6PM time, she felt fine most of the day but it was that evening she was achy. The headache started 11Jan2021 at night continued to 12Jan2021 and was still ongoing today. The right sided neck and armpit pain started yesterday 12Jan2021 and she still has it at the moment. She stated that she was probably dehydrated and still feels like she was recovering. She had right side neck swelling on 11Jan2021 and right sided under armpit pain on 12Jan2021. She has never been tested for Covid or had any antibody tests. She has had no issues with vaccines in the past. Outcome of the events 'Felt like going to pass out', 'Nausea, Vomiting', 'Upset stomach', 'Body chills and aches' was recovered on 12Jan2021; 'Headache' and 'dehydrated' were recovering; 'Right sided Neck Pain and Right sided armpit pain' was not recovered; 'dizziness' and 'right side neck swelling' were unknown. No follow-up activities are needed. No further information is expected.
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| 33 | 2021-01-25 | dizziness |
Within an hour but after the 30 minute waiting period the patient began to experience lightheadednes...
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Within an hour but after the 30 minute waiting period the patient began to experience lightheadedness, flushing, and nausea. Recieved 50 mg of IM benadryl(works in medical facility). Patient improved and was discharged to family.
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| 33 | 2021-01-25 | chills, fever |
fever, chills, body aches to right side of body, Tenderness under arm, Right buttock soreness, Lum...
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fever, chills, body aches to right side of body, Tenderness under arm, Right buttock soreness, Lump near right side of neck, next to clavicle. Ibuprofen for body aches taken sunday , Monday. Today Tuesday 1-26-21 continues with soreness to right underarm, injection site and lump on neck.
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| 33 | 2021-01-26 | headache, chills, fever |
Approximately 12 hours after shot I experienced high fever, chills, body aches and headache. Symptom...
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Approximately 12 hours after shot I experienced high fever, chills, body aches and headache. Symptoms lessened with Tylenol and have since returned. Fever now low grade, body aches and headache are mild.
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| 33 | 2021-01-26 | malaise | Body aches, no treatment, 8-10hrs malaise, no treatment, 12-24hrs |
| 33 | 2021-01-26 | headache, fatigue |
I had a headache starting at 5 Pm same day. Body aches/muscle aches in chest and back and a little b...
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I had a headache starting at 5 Pm same day. Body aches/muscle aches in chest and back and a little bit fatigued. Symptoms lasted about 24 hours. I had a little arm soreness too and that lasted two. Pregnancy: May 4 expected due date and totally normal pregnancy.
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| 33 | 2021-01-26 | fever, headache, chills |
Started with body aches at first, severe chills and fever (101.1) all throughout the night, headache...
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Started with body aches at first, severe chills and fever (101.1) all throughout the night, headache, nausea. Currently (46 hours later) - body aches, temperature of 100.2.
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| 33 | 2021-01-26 | shortness of breath |
shortened of breath; Wheezing; bronchospasm; This is a spontaneous report from a non-contactable nur...
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shortened of breath; Wheezing; bronchospasm; This is a spontaneous report from a non-contactable nurse. (patient). This 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot El3246 at the left arm on 15Jan2021 12:45 at SINGLE DOSE for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination.No COVID prior vaccination. Concomitant medications were not reported. On 15Jan2021 17:00, the patient experienced wheezing and shortened of breath. The patient visited physician office for the event and treatment for the events was received, Albuterol for bronchospasm. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected
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| 33 | 2021-01-28 | nasopharyngitis |
Cold like symptoms; had close interaction or exposure with the positive COVID-19 coworker; This is a...
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Cold like symptoms; had close interaction or exposure with the positive COVID-19 coworker; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3302), via an unspecified route of administration on 12Jan2021 reported at about 18:30 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's Medical history was reported as none. The patient's concomitant medications were not reported. This Dental Hygienist is the patient who was administered her first dose of Pfizer COVID-19 Vaccine on 12Jan2021. She felt fine before being administered that dose. When she woke up 14Jan2021, she felt cold like symptoms. She just found out today: 15Jan2021 that her coworker who previously had a negative Rapid COVID-19 test result is actually positive for COVID-19 as of today: 15Jan2021. Caller reported the last time she herself had close interaction or exposure with the positive COVID-19 coworker was last night: 14Jan2021. Caller is in the line at this time to go get tested for COVID-19; but she wanted to ask if she should still get tested for COVID-19 or still get the second dose of the Pfizer COVID-19 Vaccine. She does not know when the second dose will be scheduled; she is still waiting on the email to tell her when she is supposed to go get the second dose. She does not know if she will or will not get the second dose related to these events yet. The outcome of the event Cold like symptoms was not recovered while unknown for the event exposure.
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| 33 | 2021-01-28 | headache, fatigue, fever | Fever, fatigue, muscle aches, joint pain, headache, and swollen lymph nodes. |
| 33 | 2021-01-28 | weakness |
Joint aching; feeling of weakness in forearms, fingers, left hip and toes; not actively exercising; ...
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Joint aching; feeling of weakness in forearms, fingers, left hip and toes; not actively exercising; This is a spontaneous report from a contactable pharmacist. A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1686, intramuscular on 09Jan2021 16:45 at single dose on left arm for COVID-19 immunization. The patient is not pregnant and has no medical history, no known allergies and no prior vaccination. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC). The patient experienced joint aching and feeling of weakness in forearms, fingers, left hip and toes; not actively exercising on 13Jan2021 at 14:00. The patient had no treatment received. The outcome of the events was not recovered.
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| 33 | 2021-01-28 | shortness of breath |
Multiple Seizures unable to breathe still continuing at times still taking normal seizure meds along...
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Multiple Seizures unable to breathe still continuing at times still taking normal seizure meds along with Ativan when needed
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| 33 | 2021-01-28 | dizziness |
Within 5 minutes of dose, blurry vision and dizziness started followed by fast heart rate. pharmaci...
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Within 5 minutes of dose, blurry vision and dizziness started followed by fast heart rate. pharmacist gave 1 dose of IM EPI in the L thigh
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| 33 | 2021-02-01 | malaise, chills, dizziness, headache, fatigue |
Immediately after vaccine administration had a brief episode of dizziness. The next morning (1/21/21...
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Immediately after vaccine administration had a brief episode of dizziness. The next morning (1/21/21) noted quarter-sized red rash at injection site along with fatigue, whole body aches, that later progressed into headache, nausea and overall feeling unwell. That evening experienced chills. The following morning (1/22/21) injection site redness/rash was roughly 3in in diameter and warm to touch. Right front shoulder pain began and still continues 12 days post vaccine administration.
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| 33 | 2021-02-04 | fever, headache, dizziness |
Fever, body pain, headache, joint pain, nausea, dizziness, diarrhea, swollen pelvic glands and right...
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Fever, body pain, headache, joint pain, nausea, dizziness, diarrhea, swollen pelvic glands and right axilla
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| 33 | 2021-02-07 | dizziness |
Positive pregnancy test 1/10/21. EDD 9/18/21 based on LMP (12/12/21). Woke up extremely dizzy and co...
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Positive pregnancy test 1/10/21. EDD 9/18/21 based on LMP (12/12/21). Woke up extremely dizzy and could not get out of bed without almost falling over and very nauseated. Symptoms eventually subsided around 10:00 am. Did not have dizziness again. Had a confirmatory Ultrasound on 2/4/21 which measured 5weeks, 5 days and no yolk sac. Was supposed to be 7 weeks, 5 days. Determined that I miscarried.
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| 33 | 2021-02-07 | throat swelling |
allergic reaction to the product/ throat was swelling and started to close up/ hives and itching/ bl...
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allergic reaction to the product/ throat was swelling and started to close up/ hives and itching/ blood pressure dropped and heart rate increased/ chest tightness; This is a spontaneous report from a contactable consumer (patient). A 33-year-old-female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL3248), via an unspecified route of administration into left deltoid on 21Jan2021 10:20 at a single dose for covid-19 immunization. The patient was allergies to sulfa medications and latex and she had the flu vaccine in Nov2020. The patient concomitant medications were none. The patient called to report on the COVID 19 vaccine and she had an allergic reaction to the product. The patient explained that she got the vaccine yesterday at around 10:20 am and was in the emergency room at 10:48 am. Her throat was swelling and started to close up and this has resolved after medication. She had hives and itching which are now ongoing and about the same, her blood pressure dropped and there was an increased in her heart rate which have both gotten better, and she had chest tightness which is about the same. She received IV Benadryl, Solumedrol, and Pepcid. The patient was treated and released from the emergency room. No investigation assessment. The outcome of the event was not recovered.
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| 33 | 2021-02-16 | fever, body temperature increased |
Received 2nd Pfizer dose on 2/5/21 at 0700. On 2/6/21 around 1930 temp was 102 took Tylenol at this ...
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Received 2nd Pfizer dose on 2/5/21 at 0700. On 2/6/21 around 1930 temp was 102 took Tylenol at this time at 2200 temp was 103.7 took Advil at this time. Temp stayed 102-103.7 with Tylenol and Advil round the clock until 2/8/21 around 1300 at this time temp had gone down to 101. Noticed once fever started to drop my left toes started to tingle. Tingling got worse over the next few days until 2/11/21 my whole leg went extremely heavy (could not lift at all). Admitted to hospital 2/12/21.
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| 33 | 2021-02-16 | nerve pain, night sweats, influenza like illness, headache, dizziness, throat pain |
Vertigo, dizziness, joint pain, rash, foggy brain, inability to speak, think and memorize as normal....
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Vertigo, dizziness, joint pain, rash, foggy brain, inability to speak, think and memorize as normal. Sore throat, fluid in ears and lungs. Muscle weakness, headaches...difficulty walking. Insomnia. Flu like symptoms for 2 weeks after dose2. Nerve pain (shooting sensation down both arms. Difficulty standing for more than a few minutes, light headed. Ear pain, nausea, night sweats and unable to grasp normally. Tingling in face. Numbness in face.
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| 33 | 2021-02-16 | dizziness |
vaccine is really taking a big toll on her brain function; feels just weird, like everything is in s...
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vaccine is really taking a big toll on her brain function; feels just weird, like everything is in slow motion/feeling really weird; dizzy/lightheaded; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left deltoid on 02Feb2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient got the COVID vaccine a couple hours ago on 02Feb202 and was very lightheaded. When the patient was asked to provide her mailing address, she stated she was feeling really weird, the vaccine was really taking a big toll on her brain function, she was super dizzy and feels just weird, like everything is in slow motion. Lightheadedness started probably about 20 minutes after she had the shot, they made her wait for 15 minutes, now she just feels really weird. The patient was healthy, she just got blood tests back and everything said she is healthy. She thought they said to call if she was having a side effect of dizziness or weakness, as they are more serious, but she called her doctor and they said to call Pfizer. The outcome of the events was unknown. The patient underwent lab tests and procedures which included blood test: unknown results on unspecified date.
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| 33 | 2021-02-21 | fatigue, sweating |
For about 8 hours on the day after I received the second shot, I experienced sweats (no chills) and ...
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For about 8 hours on the day after I received the second shot, I experienced sweats (no chills) and (possibly) a fever. I felt slightly achy and tired. I did not have pain at the injection site or any difficulty lifting my arm.
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| 33 | 2021-02-21 | dizziness, sweating |
Patient became dizzy with palpitations. Developed flushing, sweating and shaky, take to Emergency r...
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Patient became dizzy with palpitations. Developed flushing, sweating and shaky, take to Emergency room where a patient developed minimal residual erythema
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| 33 | 2021-02-21 | dizziness |
Patient c/o feeling lightheaded 5 minutes after administration. BP was normal. Gave cold water. Deve...
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Patient c/o feeling lightheaded 5 minutes after administration. BP was normal. Gave cold water. Developed itchy red rash across chest ~8 minutes after administration. This began to fade ~15 minutes after administration, but patient then complained that tongue felt funny & began clearing throat. After consulting with our NP, Epipen was administered (0.3mg), & 911 called. Transported via ambulance ED. Pt reported tongue feeling better after Epipen.
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| 33 | 2021-02-21 | cough, throat irritation |
Patient was being held for monitoring after receiving the COVID-19 vaccine. Within 1-2 minutes, pat...
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Patient was being held for monitoring after receiving the COVID-19 vaccine. Within 1-2 minutes, patient developed facial redness and itching. She then started to feel as if her throat was itchy and started coughing uncontrollably. Denied lip or tongue swelling. Was feeling normal prior to receiving the vaccine. Was not recently seen/assessed for other medical care. No similar symptoms previously. Patient was taken to the Emergency Department. Ptaient did have a few red splotches on her chest, but these did not appear consistent with urticaria per the ED physician's report. ED physician felt patient's symptoms may be secondary to anxiety. However, given history of anaphylaxis and feeling of throat itching it was felt necessary to treat for possible allergic reaction. Patient was given epinephrine, Benadryl, famotidine, and Solu-Medrol. She was then monitored in the ED for 4 hours. During this time, she developed no new symptoms. She continued to breathe easily with normal and stable vital signs. She was discharged with instructions to buy OTC Benadryl 25mg PO to take every 8 hours for 48 hours. Prednisone 20mg, 3 tablets orally daily for 5 days weas prescribed. An EpiPen was also prescribed. Patient advised not to receive second dose of the vaccine and to follow up with her primary care provider.
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| 33 | 2021-02-21 | headache, fatigue |
Severe headaches exhaustion depression, crying spells, mental breakdown severe muscle spasms over th...
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Severe headaches exhaustion depression, crying spells, mental breakdown severe muscle spasms over the neck, upper, middle, and lower back Knee pain
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| 33 | 2021-02-21 | headache, shortness of breath |
poofyness, itching (hives), shortness of breath, headache, dizziness when upright, joints hurt micr...
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poofyness, itching (hives), shortness of breath, headache, dizziness when upright, joints hurt microdosing benadryl, inhaler
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| 33 | 2021-02-22 | dizziness |
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual received the Pfizer Covid-19 vaccine. He began to...
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"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual received the Pfizer Covid-19 vaccine. He began to feel dizzy and faint at 11:41 am. His vitals were 134/86, 20, 82 at 11:41 am. We applied chill towel to back of neck. B/P 104/84,20, 84 P, 98 % RA. 11:46 am. Individual report that he did not have breakfast and did not hydrate. Patient swallowing intact. He was given bottle of water. 1:58 pm vitals were 114/82, 99% SATS, 99, 18. Individual stated she felt better and was no longer dizzy. 2:04 pm vitals 118/84. 18, 72, 98% RA. After drinking 32 oz of water individual went home with family with no noted distress.
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| 33 | 2021-02-22 | fatigue, headache |
Left hand and middle finger hurt to the touch, tingly down arm, numbness in arm/hand. Hand and arm s...
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Left hand and middle finger hurt to the touch, tingly down arm, numbness in arm/hand. Hand and arm symptoms lasted approximately 48 hours from on-set. Also experienced fatigue, headache and arm soreness
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| 33 | 2021-02-22 | throat irritation, cough |
Patient presented at 5:05 with complaints of burning sensation in chest, tachycardia, throat irritat...
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Patient presented at 5:05 with complaints of burning sensation in chest, tachycardia, throat irritation and itching, mild cough, flushing of chest and face. No SOB. Pulse 120. O2 sat 99%. BP 110/70. She had a history of serious allergic reactions to foods in the past, and was familiar with the symptoms. She was provided a 25mg dose of diphenhydramine (she had previously taken 25mg prior to her vaccine, in addition to her daily allergy medication in the morning) and she was observed. over a 30 min observation period her pulse came down to under 100, her flushing and throat irritation resolved. She was feeling back to baseline and she was allowed to leave.
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| 33 | 2021-02-22 | fatigue, headache, weakness | Whole body aches, fatigue, headache, weakness |
| 33 | 2021-02-23 | shortness of breath, cough, throat swelling |
9-10min after getting the shot, my lungs felt like I was running a marathon; chest pain; my ears and...
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9-10min after getting the shot, my lungs felt like I was running a marathon; chest pain; my ears and face flushed red & hot; my ears and face flushed red & hot; coughing; choking; couldn't breathe; My throat was swelling up so fast and filling with a thick mucous; My throat was swelling up so fast and filling with a thick mucous; she was not coherent enough to remember it; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 17Feb2021 15:00 for Covid-19 immunisation, administered at hospital. Medical history included asthma, gastrooesophageal reflux disease (GERD), endometriosis, adenomyosis, polycystic ovaries (PCOS), anaphylactic reaction Known allergies: fried chicken/fast food unknown preservative (anaphylactic). Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included: levonorgestrel (MIRENA), omeprazole (OMEPRAZOLE), paracetamol (TYLENOL). No other vaccine in 4 weeks. The patient previously took cyclobenzaprine and experienced dust allergy, metronidazole and experienced drug hypersensitivity, cephalexin and experienced drug hypersensitivity, tramadol and experienced anaphylactic reaction. On 17Feb2021 03:15 PM, 9-10 min after getting the shot, her lungs felt like she was running a marathon. She told the observer and before she finished describing her chest pain, her ears and face flushed red & hot. She called for a stretcher and she started coughing. They got her on a stretcher & ran her to the ER down the hallway. She was coughing and choking and couldn't breathe. Her throat was swelling up so fast and filling with a thick mucous. Patient received treatment with an epinephrine shot, solumedrol shot, Benadryl shot & started an iv steroid that started with a V sound (between choking/epinephrine/Benadryl, she was not coherent enough to remember it). Within a few minutes her coughing subsided and she was able to breathe normally. She received an albuterol treatment at that point. She was kept under observation for 5 hours. At about the 4 hour mark she had another albuterol treatment. She has continued albuterol treatments every 4 hrs. Oral Prednisone, oral Benadryl. It's hills immediately after meds, valleys between. Patient was not tested for covid post vaccination. AEs resulted in: doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event. Reactions were ongoing. The outcome of events was recovering.
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| 33 | 2021-02-23 | fatigue |
Clinical depression (exhaustion, lack of ability to find pleasure or joy in anything, lack of intere...
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Clinical depression (exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide), fatigue, lack of focus, extreme emotional distress; Clinical depression (exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide), fatigue, lack of focus, extreme emotional distress; Clinical depression (exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide), fatigue, lack of focus, extreme emotional distress; emotional distress to include involuntary tears that would not stop; Clinical depression (exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide), fatigue, lack of focus, extreme emotional distress; This is a spontaneous report from a non-contactable consumer (the patient). A non pregnant 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 27Jan2021 at 17:45 PM, (at the age of 33-year-old) as a single dose for COVID-19 immunization. Medical history included anxiety and depression (well under control at time of vaccination), COVID-19. The patient had known allergies to soy, almonds, green beans, peas, celery, cherries, strawberries, and eggs. Concomitant medication taken within two weeks of vaccination included cetirizine hydrochloride (ZYRTEC), diphenhydramine hydrochloride (BENADRYL), fluticasone propionate (FLONASE), and unspecified birth control. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin and cefdinir and experienced drug hypersensitivity. On 01Feb2021, the patient experienced clinical depression (described as exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide). She also experienced fatigue, lack of focus, extreme emotional distress, to include involuntary tears that would not stop. The patient did not receive treatment for the events. The clinical outcome of the events clinical depression (described as exhaustion, lack of ability to find pleasure or joy in anything, lack of interest in typical daily things, thoughts of suicide), fatigue, lack of focus, extreme emotional distress to include involuntary tears that would not stop, was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. Information about lot number cannot be obtained.
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| 33 | 2021-02-28 | fever, headache, chills |
she threw up; diarrhea; body pain; She had chills; Slight headache; Feeling hot; feverish; This is a...
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she threw up; diarrhea; body pain; She had chills; Slight headache; Feeling hot; feverish; This is a spontaneous report from a contactable consumer (patient's father) and a non-contactable consumer (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and dizziness from an unknown date and unknown if ongoing, Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), diazepam (MANUFACTURER UNKNOWN) for dizziness, ethinylestradiol, norethisterone (DASETTA 1/35) for birth control and multivitamins, all from an unknown date. The patient previously received first dose BNT162B2 (lot number EH9899) on 05Jan2021. On 26Jan2021 (about 10 in night) the patient experienced she threw up, diarrhea, body pain, and chills, she experienced slight headache, feeling hot and feverish on 26Jan2021. The patient did not receive any treatment for the events. The clinical outcome of the events vomiting, diarrhea, body pain, chills, headache, feeling hot and fever was recovering (reported as getting a little better now).
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| 33 | 2021-03-01 | shortness of breath, fever, pneumonia, chills |
pneumonia; Fever; chills; nausea; difficulty breathing; This is a spontaneous report from a contacta...
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pneumonia; Fever; chills; nausea; difficulty breathing; This is a spontaneous report from a contactable other HCP (patient). A 33-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 11:00 at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient experienced fever, chills, nausea, pneumonia, and difficulty breathing on 11Feb2021 23:00 with outcome of recovering. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was not diagnosed of covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab test post vaccination: negative on 13Feb2021. Therapeutic measures were taken as a result of events (antibiotics, IV fluids, Tylenol). The patient received second dose (Lot Number: EN6201) on 12Feb2021 12:00 PM in the left arm.; Sender's Comments: There is a reasonable possibility that the events fever, chills, and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the events pneumonia and difficulty breathing with Bnt162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 33 | 2021-03-02 | headache, chills |
The individual felt neck, back and shoulder pain. Symptoms started 1-18-2021. On 1-31-21 she wen...
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The individual felt neck, back and shoulder pain. Symptoms started 1-18-2021. On 1-31-21 she went to hospital and was admitted on 2-1-21 with nausea, chilss, headaches, vomiting, and body aches. COVID-19 test was reportedly negative. All tests were normal.
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| 33 | 2021-03-02 | headache, influenza like illness, dizziness |
Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normal...
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Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient). A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 33 | 2021-03-02 | fever, chills, headache |
headache; nausea; low grade temp/fever; body aches; chills; This is a spontaneous report from a cont...
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headache; nausea; low grade temp/fever; body aches; chills; This is a spontaneous report from a contactable nurse (also the patient). A 33-year-old (also the age at vaccination) female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL8982), via an unspecified route of administration at the left arm on 24Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient had no allergies to medications, food, or other products. The patient first dose was given on 03Jan2021 02:00 PM at the left arm (lot: EL3246) for covid-19 immunization. The patient was vaccinated at a Public Health Department (also reported as Public Health Clinic/Administration facility). The patient is not pregnant. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ethinylestradiol, norethisterone (VYFEMLA), collagen and unspecified multivitamin and anti-allergy (reported as received within 2 weeks of vaccination). It was reported that the patient experienced low grade temp, fever, body aches, chills on 25Jan2021 at 04:00 AM, then fever, headache, nausea on 26Jan2021 and also headache on 27Jan2021. No treatment was received for the adverse event. The outcome of the events was recovered in Jan2021. The case/ events were considered as non-serious
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| 33 | 2021-03-03 | headache |
flare up of my autoimmune thrombocytopenia; Platelets dropped to 109k; legs covered in petechiae and...
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flare up of my autoimmune thrombocytopenia; Platelets dropped to 109k; legs covered in petechiae and bruising; legs covered in petechiae and bruising; After 2nd dose, 1 day of headache; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EK4176 intramuscular in left deltoid on 07Jan2021 as single dose (at the age of 33 years) for COVID-19 immunisation. Patient had history of ongoing Autoimmune Thrombocytopenia from May2020, ongoing migraines, depression/anxiety and ADHD, and COVID-19 21Apr2020 to "05May2021". Concomitant medication included Sertraline Hydrochloride (ZOLOFT), Lisdexamfetamine mesilate (VYVANSE), Lorazepam (Ativan), Ondasetron (ZOFRAN) and Sumatriptan succinate (IMITREX). Historical information regarding dose 1 of BNT162B2 on 17Dec2020 included a moderate injection site reaction lasting 6 days worst on day three. Reaction was characterized by redness, swelling elevated rash surrounding injection site, aching pain radiating from neck to fingers and tenderness to palpitation. 1st dose Vaccine Lot Number: EJ1685, Vaccine Lot Expire Date: Mar2021, Time the Vaccination Was given: 08:00. After the 2nd dose the patient experienced a moderate headache on 08Jan2021 12:00 for 1 day which responded well to APAP- caffeine and resolved on 09Jan2021 12:00 Patient had a flare up of my autoimmune thrombocytopenia as evidenced by legs covered in petechiae and bruising on 09Jan2021. Emergency room and physician office were not visited however, patient does have standing CBC orders from hematologist, so she had platelet count checked. It had dropped to 109K/uL, which is low for me but not dangerous. Patient originally developed autoimmune thrombocytopenia (ITP) May2021 after COVID Apr2021. Both instances of these side effects were manageable, but patient wanted to report them as there was no data yet available on ITP with the vaccine when she met with hematologist to discuss it. Patient received Acetaminophen 650mg PO (per oral) as treatment. Lab data included Platelets 13Oct2020 124 kiU/L (normal 140-400) and on 12Jan2021 109 KiU/L. Event flare up of my autoimmune thrombocytopenia resolved on 31JAN2021 00:00, Platelets dropped to 109k resolved on 31JAN2021 00:00, legs covered in petechiae and bruising resolved on 31JAN2021 00:00 and headache resolved 09Jan2021.
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| 33 | 2021-03-09 | chills, headache, fever |
body aches; chills; my back started aching; feeling feverish but no fever; felt like a headache was ...
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body aches; chills; my back started aching; feeling feverish but no fever; felt like a headache was coming on/was going to get a headache; her arm hurt/arm pain/iced the injection site; never falling back asleep; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Feb2021 15:15 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 12Jan2021 for COVID-19 immunization. After 2nd vaccine. The patient felt fine most of the evening and through the night. The patient woke up in the middle of the night around 3/3:30 am (totally normal for her) and felt fine except for some arm pain on 05Feb2021. The patient iced the injection site, but by 4:30/5 the patient was still awake and now felt like she was going to get a headache (also common for patient). The patient took her temperature (was normal), took 2 Tylenol (5am), and went back to bed (but never falling back asleep). The patient left for work at 6:45am. The patient felt totally fine, even energetic, most of the morning. The following day at 10 am caller reported body aches and feeling feverish but no fever. At almost 10am exactly, her back started aching and by 10:30 the patient had full body aches and started getting chills. The patient left work at 11am, was home before 12pm with a temperature of 98.5, took 2 more Tylenol and napped. The patient had no symptoms the rest of the afternoon until 5pm when the back aches returned. Took 2 more Tylenol. The patient napped later in the evening, too, but took 2 more Tylenol at 10pm before going to sleep for the night. Woke up Saturday morning without symptoms. The outcome of events was recovered in Feb2021. Information about Lot/batch number requested.
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| 33 | 2021-03-14 | fever, chills, headache |
Head ache; Fever; Chills; Muscle soreness; Soreness at injection site; This is a spontaneous report ...
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Head ache; Fever; Chills; Muscle soreness; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (formulation: Solution for injection), via an unspecified route of administration in the Left arm on 01Feb2021 16:00 at single dose for covid-19 immunization. Medical history included asthma and Allergy to penicillin. Concomitant medication included drospirenone (SLYND), fish oil, vitamin D and berberine. On 01Feb2021, the patient experienced head ache, fever, chills, muscle soreness and soreness at injection site. On 01Feb2021, the patient underwent lab tests and procedures which included body temperature: fever. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 33 | 2021-03-18 | fever, chills |
24 hours after injection: sharp stomach pain that roamed around the abdomen, 27 hours after injecti...
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24 hours after injection: sharp stomach pain that roamed around the abdomen, 27 hours after injection: fever and chills, abdominal pain did not go away by night so I went to the ER 35 hours after injection. I had a urinalysis, blood test, and an ultrasound to find the site of pain. The ultrasound showed appendicitis. 41 hours after injection I had an appendectomy
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| 33 | 2021-03-18 | headache |
Bleeding started really heavy/ Soaking up a bunch of different pads; Really bad pain in stomach as w...
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Bleeding started really heavy/ Soaking up a bunch of different pads; Really bad pain in stomach as well as right pelvic area; Really bad pain in stomach as well as right pelvic area; Pain in right chest area; bunch of pain; Headache; Diarrhea; Nausea; Pain where I got the shot; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200) via an unspecified route of administration in the left arm on 28Feb2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient mentioned that the only medication she was taking was birth control. The patient got the COVID-19 vaccine on Sunday and had the normal side effects like headache, diarrhea, nausea and pain where she got the shot. The patient took Excedrin extra strength on Sunday night. Then on Monday night (01Mar2021) when she went to sleep there was pain in her chest, her right chest area there was in a bunch of pain. When the patient woke up on Tuesday morning (02Mar2021), she had bleeding, and that bleeding started really, really heavy. She just came off of her period a week ago. She had a full blown period for an entire week and then on Tuesday the patient started bleeding very, very heavily. She was soaking up a bunch of different pads. She was not sure what it was, she had pain, really bad pain in stomach as well as like pain in her pelvic area, right pelvic area. Patient weight was 135 (units unknown). The outcome of the events was unknown.
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| 33 | 2021-03-20 | headache |
major depression; headache; This is a spontaneous report received from a contactable other healthcar...
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major depression; headache; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 13Feb2021 07:00, as single dose, for covid-19 immunisation, at the hospital. Medical history included COVID-19 (prior vaccination). The patient was not pregnant at the time of vaccination and has no allergies. There were no concomitant medications. On 15Feb2021 at 02:00, the patient experienced headache and major depression. The events resulted to physician office visit. No treatment was given for the events. The outcome of the events was not resolved. Information on the batch/lot number has been requested.; Sender's Comments: The event major depression is likely an intercurrent medical condition and is unrelated to suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 33 | 2021-04-06 | shortness of breath |
On the evening of 4/3/2021 the patient was at home, prone in bed, gasped suddenly and became unrespo...
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On the evening of 4/3/2021 the patient was at home, prone in bed, gasped suddenly and became unresponsive. EMS was called and unable to resuscitate. She expired.
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| 33 | 2021-04-06 | migraine, chills, sweating, dizziness, headache, fever |
the back (mostly left side) of her head gets so tight and sore; felt like the back of her skull was ...
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the back (mostly left side) of her head gets so tight and sore; felt like the back of her skull was fractured/the back (mostly left side) of her head gets so tight and sore; all color drained from her face; tunnel hearing; tunnel vision; felt the worst feeling about to faint; felt a "static" feeling all over her body; throwing up; fever; migraine; aches; Chills; hot sweats; This is a spontaneous report from a contactable consumer (the patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6207), via an unspecified route of administration in the left arm on 13Mar2021 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma and lactose Intolerance- not allergy though (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: fluticasone propionate/ salmeterol xinafoate (ADVAIR), loratadine, bupropion hydrochloride (WELLBUTRIN), and vitamins (as reported), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6200), via an unspecified route of administration in the left arm on 20Feb2021 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient stated that 24 hours after her second dose (14Mar2021 12:00), she felt the worst feeling about to faint, all color drained from her face. She got tunnel vision/hearing and felt a "static" feeling all over her body. Then started throwing up. She took a nap and woke up an hour later with 101.2 (degree) fever (14Mar2021) and fought that, along with migraine, aches, chills, hot sweats (14Mar2021). About 8 hours after initial fever (14Mar2021), it spiked to 102.4 (degree) for two hours. It came down quick. The next day, 15Mar2021, it felt like the back of her skull was fractured. And since then (unspecified date), the back (mostly left side) of her head gets so tight and sore especially when laying down. She has been sleeping on heating pad for 10 days now, and it got a little better but still super sore (head). The events involved a doctor or other healthcare professional office/clinic visit. Treatment was received for the back (mostly left side) of her head gets so tight and sore. There was no treatment for the other events. The outcome of the events was recovered with sequelae. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 34 | 2020-12-31 | headache, chills, dizziness, fever, sweating, fatigue |
Chills, fatigue, muscle aches, fever with period of sweats, swollen neck lymph nodes, dizzy, diarrhe...
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Chills, fatigue, muscle aches, fever with period of sweats, swollen neck lymph nodes, dizzy, diarrhea, pounding headache. Symptoms have started to occurr on 12/28, until now jan 1st, 2021. It consumes my whole body, to eve. Get up from bed or even walk 10ft to the bathroom. Its very difficult, I am a single mom with 3 kids.
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| 34 | 2020-12-31 | headache |
I received the vaccine at 10:30 am. About two hours later I noticed a minor headache. By 4pm I had a...
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I received the vaccine at 10:30 am. About two hours later I noticed a minor headache. By 4pm I had a moderate pounding headache. Around 4:30pm, I noticed minor unilateral scalp, facial and neck numbness on the left side. These symptoms lasted about a week, but slowly improved. Four days after the vaccine I had very tender lymph nodes on the left ear area. Today marks two weeks exactly since I received the vaccine and two days ago I noticed slight increase in numbness on the left cheek again which again, is slowly improving. However, I also wear Invisalign at sometimes notice that I bite my cheek while asleep. I also wear N95 masks four days of the week which are quite tight on the face. The injection site (Left deltoid) was moderately sore for the first few days and still two weeks later has minor soreness the comes and goes.
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| 34 | 2020-12-31 | dizziness |
It was almost the end of my 15 minutes when my limbs became tingly and that feeling made its way tow...
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It was almost the end of my 15 minutes when my limbs became tingly and that feeling made its way towards my torso. I started to feel flush and my heart rate rapidly increased. I felt it was nothing so i tried to calm myself and watch my heart rate on my watch and it continued to increase. It started at 100 and within a minute was at 130. I finally honked my horn for assistance and my symptoms continued. I became very faint and nauseous and felt as though i was going to throw up. open my door and took my mask off to help with getting air and it didn't do much to help. I felt very light headed and uncomfortably closet o passing out than i ever have. This lasted for a good 10 minutes until it slowly passed. Faint, nauseous, hot and rapid heart rate of 130 were my main symptoms and were very uncomfortable.
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| 34 | 2020-12-31 | headache |
Patient reported one day post immunization moderate body aches, headache, severe throbbing injection...
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Patient reported one day post immunization moderate body aches, headache, severe throbbing injection site.
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| 34 | 2021-01-02 | sweating, chills, fever, night sweats |
About 12 hours after the vaccine, I started developing chills and joint pain. That night, I develop...
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About 12 hours after the vaccine, I started developing chills and joint pain. That night, I developed fevers that persisted for about 24h (spiked about 5 separate times - highest fever was 102). Then, on the third night after the vaccine (about 60 hours post vaccine), I had two separate episodes of night sweats (clothes were drenched, no fever). Later that night I had a bowel movement with bright red blood. I then went to an urgent care where they drew labs, send a Covid swab, ordered stool studies, and ordered a CT abdomen.
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| 34 | 2021-01-02 | dizziness, headache |
At 1606 Patient reporting lightheadedness, bilateral hand tingling and numbness. Also reporting gene...
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At 1606 Patient reporting lightheadedness, bilateral hand tingling and numbness. Also reporting generalized headache 6/10. States that she has not eaten any food today except coffee. BP 88/49. HR 45 Patient was laid flat and legs elevated. Repeat BP 1613 101/59. Patient reported bilateral arms feeling "cold". O: Patient alert and oriented, following commands, no focal weakness. BUE cool to touch. EMS called at 1609. ED arrival 1620. Repeat VS 1620 105/65 HR 55 Upon EMS arrival patient declined to receive further treatment and signed AMA paperwork. Discussed with patient to return to ED for any further worsening of symptoms.
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| 34 | 2021-01-02 | body temperature increased, fatigue, throat pain, headache, throat irritation |
I had an allergic reaction within ten minutes and was taken to the emergency room with throat pain, ...
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I had an allergic reaction within ten minutes and was taken to the emergency room with throat pain, itching in the throat and mouth and a swollen uvula. I was given multiple doses of Benadryl and steroids. The next day I developed a temperature of 102 degrees and had a severe headache, nausea, and body aches. The headache and fatigue are still present now 4 days later.
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| 34 | 2021-01-03 | body temperature increased, malaise, headache, fatigue, dizziness |
COVID-19 Vaccine #1 received on 12/29/20 @11:40am- That afternoon, mild soreness @ injection site. 1...
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COVID-19 Vaccine #1 received on 12/29/20 @11:40am- That afternoon, mild soreness @ injection site. 12/30/21- moderate pain in upper arm and sharp, stabbing pain in axilla (injection site side). Unable to lift arm straight up due to pain. Evening: Myalgia/joint pain, fatigue, nausea, mild headache. Took Tylenol and Phenergan. 12/31/21- Woke up at 4am with pain in axilla-took tylenol. Moderate pain in upper arm and axilla. Unable to palpate axilla due to pain while at work. Evening: axillary lymphadenopathy noted- walnut sized. Severe myalgia/joint pain, fatigue, nausea, headache, malaise. Took Motrin and Phenergan. Woke up in middle of night with pain in arm/axilla and nausea. took tylenol and zofran. 1/1/21- Worst day of symptoms. Moderate-severe pain in upper arm and axilla. Golf ball sized lymphadenopathy in axilla on injection side. Severe weakness, dizziness, fatigue, myalgia, and joint pain. Low grade temp (99.7), tachycardia (HR averaged 110-115), shortness of breath on exertion with associated tachypnea (RR 24-26). No appetite and nausea. Stayed in bed ALL DAY. Alternated Tylenol/ Motrin, Benadryl & Zofran as needed. Only reason I did not go to ED is because I had a pulse oximeter at home was monitoring O2 sats closely. Never de-sat'ed. Had I not had the pulse ox at home, I would've gone to ED. In the evening, had lymphadenopathy in neck also (same side as injection). 1/2/21- Most symptoms have dissipated except axillary lymphadenoapthy- axilla incredibly tender-golf ball sized. Lymph nodes in neck still palpably enlarged. 1/3/21- Lymph nodes in neck normal. Axillary lymphadenopathy remains with same tenderness. 1/4/21 AM- NO change in axillary lymphadenopathy-tenderness same
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| 34 | 2021-01-03 | fatigue, chills | DEVELOPED FATIGUE, CHILLS, FEELING OF SOMETHING HEAVY ON CHEST, CONFUSION |
| 34 | 2021-01-03 | fatigue, shortness of breath, dizziness |
Flushing; she noticed that there was a ringing in her left ear; Experienced a weird heaviness on her...
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Flushing; she noticed that there was a ringing in her left ear; Experienced a weird heaviness on her upper chest and arms/ heavy legs and arms/really heavy arms and legs; experienced a weird heaviness on her upper chest and arms; really cold hands; felt really hot at the injection site/really hot sensation at injection site; lightheadedness/Light-headed; Palpitations; Feeling faint; shortness of breath; Her blood pressure went up to 134/100; paleness; went up to her face; felt tired/She was really tired and slept it off; This is a spontaneous report from a contactable nurse, who is also the patient. This 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) intramuscular in the left deltoid on 20Dec2020 at single dose for COVID-19 immunisation. Relevant medical history included ongoing asthma (diagnosed as a teenager with sports asthma and uses an inhaler). There were no concomitant medications. The patient experienced lightheadedness/light-headed (medically significant) on 20Dec2020 with outcome of recovering, palpitations (medically significant) on 20Dec2020 with outcome of recovered on 20Dec2020, feeling faint (medically significant) on 20Dec2020 with outcome of recovered on 22Dec2020, flushing (medically significant) on 21Dec2020 with outcome of recovered on 22Dec2020, she noticed that there was a ringing in her left ear (medically significant) on 21Dec2020 with outcome of recovering, shortness of breath (medically significant) on 20Dec2020 with outcome of recovering, her blood pressure went up to 134/100 (non-serious) on 20Dec2020 with outcome of recovered on 20Dec2020, she experienced a weird heaviness on her upper chest and arms (non-serious) on 21Dec2020 with outcome of recovering, really cold hands (non-serious) on 21Dec2020 with outcome of not recovered, paleness (non-serious) in Dec2020 with outcome of unknown, felt really hot at the injection site/really hot sensation at injection site (non-serious) on 21Dec2020 with outcome of recovered on 23Dec2020, went up to her face (feeling hot) (non-serious) in Dec2020 with outcome of unknown, heavy legs and arms/really heavy arms and legs (non-serious) on 21Dec2020 with outcome of not recovered and felt tired/she was really tired and slept it off (non-serious) in Dec2020 with outcome of unknown. The patient specified that she experienced a moderate reaction after having the COVID-19 vaccine. She had the vaccine last Sunday morning 20Dec2020. She was told to wait 20 minutes before leaving. In the waiting area, she felt lightheaded, had palpitations and was feeling faint. After 20 minutes she started feeling better. Then she started to have more intense light headedness. She went to the ER and was given oxygen. Her blood pressure was 134/100 on 20Dec2020. She had an EKG on 20Dec2020 that was normal. They gave her steroids and Benadryl. She had another episode while being injected with the steroids. On Monday 21Dec2020, she experienced a weird heaviness of her upper chest and arm. She had really cold hands and flushing. On Monday night 21Dec2020 she went to work. She experienced a really hot sensation to the injection site that went to her neck and face. Her left ear was ringing. This lasted until Tuesday 22Dec2020. She took Benadryl again on Tuesday 22Dec2020. She had shortness of breath which started on 20Dec2020 and on 22Dec2020 she had shortness of breath that lasted until 11am. She had really heavy legs and arms and went back to the ER. She had a chest X-ray and D-dimer on 22Dec2020 that were normal per the ER. The night before the report, she had some of the same symptoms. She was really tired and slept it off. She didn't take anything. The morning of the report, she was feeling good and better. She still has heavy feeling on upper chest and arms. Caller clarifies that she did not have a heavy feeling in her legs. Her arms feel heavy if she holds her phone too long. She continues to have ringing in her ear. The flushing went up to her face. The patient specified that she developed sports asthma as a child and uses an inhaler. She gets short of breath if she overexerts herself. Additional laboratory investigations on 20Dec2020 included blood work with unknown results and Troponin which was normal. She was provided with a general steroid. She did not know the name of it. She was also given Benadryl and monitored on telemetry. She was given IV fluids again on 22Dec2020.; Sender's Comments: Based on the compatible temporal association and the known pattern of response, the Company considers the reported events are possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 34 | 2021-01-03 | dizziness | Hot and lightheaded |
| 34 | 2021-01-03 | skin warm |
On the 16 early in the morning I woke up with a circular, itchy, warm, red rash. I went to Employee...
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On the 16 early in the morning I woke up with a circular, itchy, warm, red rash. I went to Employee Health and was prescribed a steroid but I didnt take it and benedryl and claritin. I took claritin and benedryl for about 2 days which began to make the rash subside on the 18 but on the 23rd the rash reappeared and went back to EH and was given another round of steroids which I did in fact take this time. And after the 6th day of the steroid pack the rash has mostly resolved
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| 34 | 2021-01-03 | fatigue, shortness of breath, chills, fever |
SOB day of vaccination; not critical. Flushing of ears and face roughly 9 hours after vaccination; f...
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SOB day of vaccination; not critical. Flushing of ears and face roughly 9 hours after vaccination; followed by fevers 101.0-101.5 overnight. Next day chills, ?feeling of burning from the inside out bilaterally in my lower extremities,occassionally drifting to arms.? Also fatigue.
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| 34 | 2021-01-03 | fatigue, shortness of breath, headache | SOB, chest tightness, HA, extreme fatigue |
| 34 | 2021-01-03 | chills, headache, fever |
Slight headache a few ours later after vaccination. The next morning I had headache, some joint/mus...
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Slight headache a few ours later after vaccination. The next morning I had headache, some joint/muscle pain, right arm pain and a Fever. That evening/night Fever and chills. The following morning still had a fever and chills. All symptoms were gone later that evening (within 48 hours of initial vaccination time)
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| 34 | 2021-01-04 | headache, dizziness | Dizzy, headache, felt faint, high HR, felt off - few episodes for about 30 min after injection |
| 34 | 2021-01-04 | headache |
Estimated due date 06/24/2021. I just had arm pain at the injection site and severe headaches for ab...
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Estimated due date 06/24/2021. I just had arm pain at the injection site and severe headaches for about 2 days.
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| 34 | 2021-01-04 | fatigue |
Felt hot/flushed almost immediately after vaccine. Continued to have hot flashes (afebrile) relieved...
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Felt hot/flushed almost immediately after vaccine. Continued to have hot flashes (afebrile) relieved by Tylenol through the following Tuesday (5 days after vaccine). Hot flashes are intermittent. Also feel fatigued starting Saturday 1/2, improved 1/3, worsening 1/4 into 1/5. Sore arm for about couple days, very mild.
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| 34 | 2021-01-04 | cough, fever, headache, dizziness |
Fever; Cough; Body aches; Headache; Back pain; Dizziness; increased heart rate; Insomnia; This is a ...
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Fever; Cough; Body aches; Headache; Back pain; Dizziness; increased heart rate; Insomnia; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on right arm at 09:30 AM on 21Dec2020 at single dose for COVID-19 immunization. Medical history reported as none, no known allergies. The patient's concomitant medications were not reported. The patient experienced fever, cough, body aches, headache, back pain, dizziness, increased heart rate, insomnia at 01:00 PM on 24Dec2020. All events were reported as non-serious. The patient received Tylenol as treatment. The outcome of events was unknown. The patient was not diagnosed COVID prior vaccination, patient was not tested COVID post vaccination. Information about lot/batch number has been requested.
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| 34 | 2021-01-04 | fever, chills, fatigue |
Fever; chills; fatigue; body aches; sore arm; This is a spontaneous report from a contactable other ...
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Fever; chills; fatigue; body aches; sore arm; This is a spontaneous report from a contactable other health professional (patient). A 34-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 24Dec2020 09:15 at single dose on left arm for COVID-19 immunization in hospital. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, fatigue, body aches, sore arm from 24Dec2020 21:00. No treatment received for the adverse events. The outcome of the events was recovered on an unspecified date in Dec2020. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. No follow-up attempts are possible, information about batch number cannot be obtained.
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| 34 | 2021-01-04 | chills, throat pain, headache | Headaches, chills, sore throat and anxiety |
| 34 | 2021-01-04 | dizziness, fatigue, weakness |
Light headedness/Dizziness/Feeling like I am going to faint; Body weakness like uncontrollable fatig...
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Light headedness/Dizziness/Feeling like I am going to faint; Body weakness like uncontrollable fatigue; Body weakness like uncontrollable fatigue; severe stomach pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiration date: 30Mar2021), via an unspecified route of administration on 27Dec2020 at single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis and fibromyalgia. Concomitant medication included duloxetine hydrochloride (CYMBALTA) as thyroid medication (when probed for thyroid medication, consumer stated, "CYMBALTA." (Indication was not clarified further)) and the patient also took her thyroid medications, medication for fibromyalgia. Consumer stated that she just got the COVID vaccine, her first COVID vaccine yesterday (27Dec2020) and she was experiencing some side effects that were more severe than just pain in my arm. When clarified if had pain in arm, consumer stated "No", she was experiencing light headedness, dizziness, feeling like I am going to faint, severe stomach pain, body weakness like uncontrollable fatigue in Dec2020. The outcome of the events was unknown.
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| 34 | 2021-01-04 | nerve pain |
Nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists.; Nerve pain in lowe...
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Nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists.; Nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists.; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK5730), via an unspecified route of administration on the right arm on 18Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included Gyn issues, migraine and headaches but otherwise healthy. The patient also had allergies with sulfa, leminine, and latex sensitivity but not anaphylactic. Concomitant medications included elagolix sodium (ORILISSA), and calcium carbonate, colecalciferol, phytomenadione (VIACTIV). It was mentioned that prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. On 19Dec2020 14:00, the patient experienced nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists. The patient did not receive any treatment for the events. Outcome of the events were not recovered.
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| 34 | 2021-01-04 | shortness of breath |
Presented difficulty breathing and some pressure on the chest. Started 24 hours after the vaccine. T...
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Presented difficulty breathing and some pressure on the chest. Started 24 hours after the vaccine. The symptoms lasted 48hours. No treatment was taken, symptoms disappeared after 48 hours
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| 34 | 2021-01-04 | fatigue, chills |
Vomiting; chills; Diarrhea; Nausea; fatigue; This is a spontaneous report from a contactable nurse(p...
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Vomiting; chills; Diarrhea; Nausea; fatigue; This is a spontaneous report from a contactable nurse(patient). A 34-year-old female patient received first dose BNT162B2 (lot number: EL0140), via an unspecified route of administration on 28Dec2020 07:00 at 34 years old at single dose at Left arm for COVID-19 immunization. Medical history included Migraines, asthma, chronic bronchitis, PCOS, Allergies to Penicillin. The concomitant medications were biotin, bifidobacterium infantis, lactobacillus acidophilus(PROBIOTIC), Multivitamin, vitex agnus castus. The patient previously took codeine and experienced allergies. Nausea and fatigue beginning about four hours after administration on 28Dec2020 11:00. Diarrhea beginning about six hours after administration on 28Dec2020 13:00. Vomiting and chills beginning about eight hours after administration on 28Dec2020 15:00. There was no treatment received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was Recovering.
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| 34 | 2021-01-04 | chills, throat pain, headache, fever, cough |
called in sick 12/30/20, having fever, chills, body aches, cough, sore throat, and headache, tested ...
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called in sick 12/30/20, having fever, chills, body aches, cough, sore throat, and headache, tested for COVID 1/4/2021 it was Negative
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| 34 | 2021-01-05 | fever, headache, fatigue, chills |
1/6/2021 1245 am: chills, fever. Body ache, left arm aching, headache, fatigue 1:30pm: chills, fev...
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1/6/2021 1245 am: chills, fever. Body ache, left arm aching, headache, fatigue 1:30pm: chills, fever, body aches, headache fatigue
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| 34 | 2021-01-05 | chills, headache, fatigue, fever |
1/6/21: 1245 am. Chills. Fever, headache, body aches, fatigue 1/6/21: 1:30pm tmep 99.7, body aches....
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1/6/21: 1245 am. Chills. Fever, headache, body aches, fatigue 1/6/21: 1:30pm tmep 99.7, body aches. Fatigue. Chills
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| 34 | 2021-01-05 | fever |
12 hours after vaccination I got a low grade fever of 101. I had severe body back aches that were so...
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12 hours after vaccination I got a low grade fever of 101. I had severe body back aches that were so severe I had a difficult time walking. My injection site (Left deltoid) was swollen and sore, although not more than usual after receiving a vaccine. I had no headache at all. The major concern was the fever and the backaches. I could not get warm, and I was shaking badly because I was so cold. I had ZERO relief despite taking 700 Mg of Tylenol. Side effects finally subsided after about 5 hours.
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| 34 | 2021-01-05 | dizziness, shortness of breath |
Allergic reaction, shortness of breath, dizziness, itchiness Iv steroids and Benadryl and follow up...
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Allergic reaction, shortness of breath, dizziness, itchiness Iv steroids and Benadryl and follow up with pcp
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| 34 | 2021-01-05 | dizziness |
Evening of the 18th I became dizzy and nauseated, worsening the next day. It felt like how I have pa...
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Evening of the 18th I became dizzy and nauseated, worsening the next day. It felt like how I have patients describe migraines where noises make them feel dizzy, but I did not get a headache. Movements, lights and noises made the symptoms worsen. I was feeling better by the 21st and now symptoms have resolved.
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| 34 | 2021-01-05 | fever | Fever |
| 34 | 2021-01-05 | fatigue, headache, fever |
Fever up to 102 accompanied by headache, fatigue and significant body aches. Onset of severe symptom...
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Fever up to 102 accompanied by headache, fatigue and significant body aches. Onset of severe symptoms about 12.5 hours after administration, treated with Tylenol (1gm q6H) and ibuprofen 600mg q6H alternating. Fever initially unresponsive to antipyretic. 24 hours post-administration has decreased to 99.4.
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| 34 | 2021-01-05 | headache |
Headache; This is a spontaneous report from a non-contactable other healthcare professional. A 34-y...
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Headache; This is a spontaneous report from a non-contactable other healthcare professional. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK9231, via an unspecified route of administration from 31Dec2020 08:30 to 31Dec2020 08:30 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache on 01Jan2021 07:30 with outcome of recovered. No treatment received. No follow-up attempts are possible. No further information is expected.
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| 34 | 2021-01-05 | headache, chills |
I initially had chills, myalgias, headache, and nausea (starting later that evening), which I recogn...
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I initially had chills, myalgias, headache, and nausea (starting later that evening), which I recognized as normal immune reactions. It lasted until about 24 hours after the vaccine. Over the last week, I?ve had horrible insomnia, waking up multiple times throughout the night with difficulty falling back asleep. I didn?t think much of it other than it?s very unlike me until a handful of other coworkers vaccinated around the same have also been experiencing this.
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| 34 | 2021-01-05 | cough |
Pt received dose and within a few minutes (while in observation) started coughing and complaining of...
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Pt received dose and within a few minutes (while in observation) started coughing and complaining of chest tightness. Sx progressed to audible wheeze and patient was give Epinepherine 0.3mg IM X1 and was taken via wheelchair to ER. Pt received second dose of Epi via (ER) orders. Pt was also given solumedrol125mg, diphenhydramine 50mg, famotidine (injectable). Pt was also give albuterol via nebulizer. After full evaluation it was determined pt was having acute asthma exacerbation and anxiety. About two hours after incident - plan was to observe pt for another hour and discharge home with oral steroid.
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| 34 | 2021-01-05 | chills, headache, fever |
Since the vaccine I have been having right sided hearing loss. Two days after my first dose I felt l...
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Since the vaccine I have been having right sided hearing loss. Two days after my first dose I felt like I was underwater when talking to people, as their speech was distorted. I also felt pressure in my ear, as if it was filled with fluid, and was unable to "pop" my ears. I was evaluated by an ENT and there was no infection or fluid in my ear. It started to get better a little. After my second dose, the symptoms worsen. My hearing loss was back worse than the original time and this time I had tinnitus constantly. I also had chills, fevers, myalgia, back pain, and headaches.
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| 34 | 2021-01-06 | nasal congestion, fever, chills, fatigue |
1) fever/chills/feverish ~96 h 2) severe myalgia ~36h 3) Chest Pain ~1-2 h 4) SOA ~24 h 5) Altered t...
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1) fever/chills/feverish ~96 h 2) severe myalgia ~36h 3) Chest Pain ~1-2 h 4) SOA ~24 h 5) Altered taste ~12h 6) No appetite ~48h 7) Fatigue (couldn't stay out of bed) ~24h 8) Nausea, intermittent ~24h 9) Brain fog ~6h 10) Nasal congestion ~72h 11) Full body COVID like rash with itching on 1/2 ~36h 12) Arm sore/stiff (severe) ~24h 13) Vasovagal episode ~10min
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| 34 | 2021-01-06 | headache, fatigue |
1/7/21 Patient reported that she had an immune system response a week after she received the Covid v...
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1/7/21 Patient reported that she had an immune system response a week after she received the Covid vaccine on 12/22/20 that sent her into a Lupus flare up. Her Lupus had been under control, but this was the worst flare-ups that she has had. She said she could not even move and her husband had to pick her up. She had head to toe joint pain and rated this a 10. She also had had headache and extreme fatigue. She saw a physician and she was tested for Covid, strep and influenza, which were all negative. She was prescribed emergency steroids. She did not miss any work because she was on scheduled PTO time. Saw her Rheumatologist ion 1/6 and her hydroxy-chloroquine dose was doubled. Still having fatigue, headaches and joint pains, which she said are not her usual Lupus symptoms. She saw her Rheumatologist again yesterday and he is recommending that she not receive the second vaccine dose.
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| 34 | 2021-01-06 | discomfort, headache |
12/21 VACCINE 11:30. BY 12:30 , TINGLING/NUMBNESS ON L CHEEK BONE. 12/22 I STARTED FEELING MORE NUM...
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12/21 VACCINE 11:30. BY 12:30 , TINGLING/NUMBNESS ON L CHEEK BONE. 12/22 I STARTED FEELING MORE NUMBNESS AND PRESSURE ON L CHEEK, TINGLING OF LIPS ON L SIDE, HA ON L SIDE. WENT TO THE ER AROUND 5PM. I TOOK SOME IBUPROFREN, TYLENOL. 12/23 SOMEWHAT RESOLVED FOLLOWING WEEK; SWOLLEN LYMPHNODES ON L SIDE , BACK OF HEAD. COVID TEST; NEGATIVE
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| 34 | 2021-01-06 | dizziness |
Also had dizziness while sitting down. Felt like I would have fallen if I stood up so I sat for 20mi...
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Also had dizziness while sitting down. Felt like I would have fallen if I stood up so I sat for 20mins.; Mental confusion; couldn't gather my thoughts or write what I wanted to say; mental 'fog'; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 34-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm, on 28Dec2020 13:15 at single dose for COVID-19 immunization. Medical history allergy to penicillin. The patient is not pregnant during the time of vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and cefalexin (KEFLEX) and experienced allergies to both. The patient experienced mental confusion, mental 'fog', "couldn't gather my thoughts or write what I wanted to say", also had dizziness while sitting down (felt like I would have fallen if I stood up so I sat for 20mins) all on 28Dec2020 at 13:15. The patient did not receive treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 28Dec2020 at 13:45 (reported as events subsided after 30 minutes). The reporter assessed the case as non-serious.
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| 34 | 2021-01-06 | chills | Body Aches and chilling |
| 34 | 2021-01-06 | fatigue, headache, chills | Chills, fatigue, headache |
| 34 | 2021-01-06 | chills, headache, throat pain, fever | Chills, fever, full body muscle aches, diarrhea, nausea, headache, sore throat, ear pain |
| 34 | 2021-01-06 | headache, dizziness |
Estimated due date: 04/10/2021 I started to get very flush and warm, dizzy so I had to sit down for...
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Estimated due date: 04/10/2021 I started to get very flush and warm, dizzy so I had to sit down for a moment (I had to stop the procedure I was doing in order to sit down and drink some water). I kept trying to hydrate and had a headache the rest of the day and it went through the evening and night. I did not take anything and went to bed with the headache and woke up and felt fine.
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| 34 | 2021-01-06 | fever, chills | Fever 104.0F, chills, aches |
| 34 | 2021-01-06 | fever, headache | Fever, aches, headache, Tylenol and rest. Recovered after 1 day |
| 34 | 2021-01-06 | fever, fatigue, chills |
Fever, chills, tiredness, swollen lymph node (under armpit), upset stomach. This all occured after 1...
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Fever, chills, tiredness, swollen lymph node (under armpit), upset stomach. This all occured after 10pm the day of the shot
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| 34 | 2021-01-06 | headache | Headache |
| 34 | 2021-01-06 | chills, headache |
Headache, chills and significant body aches (back, neck, arms, legs) starting about 4 hours after ad...
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Headache, chills and significant body aches (back, neck, arms, legs) starting about 4 hours after administration.
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| 34 | 2021-01-06 | chills, dizziness, fever |
Increased BP, nausea, lymph node under right arm swollen, fever,aches, chills, dizziness. Also unbea...
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Increased BP, nausea, lymph node under right arm swollen, fever,aches, chills, dizziness. Also unbearable pain in that arm. Ended up with a trip to the ER with diagnoses of cellulitis to the right arm, (same as vaccinated arm). Currently taking antibiotics.
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| 34 | 2021-01-06 | dizziness |
Light tingling/numbness on Right side down to hands and toes, then through whole body. Began feeling...
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Light tingling/numbness on Right side down to hands and toes, then through whole body. Began feeling light-headed briefly. Narrative: Patient sat through most of anticipated monitoring time without incident, the reported tingling and numbness developing on the right side which fairly quickly expanded to entire body. Reported mild light-headedness. Continued to monitor closely without other intervention required. Patient stood up, reported feeling better and resolution of symptoms with that movement. Continued to monitor a few more minutes. Patient left area symptom-free at 12:00 with teaching of appropriate calls to make or where to return to should she be further symptomatic.
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| 34 | 2021-01-06 | headache, chills | Myalgia all over the body, headache, nausea, vomiting x1, intermittent sheivering and feeling hot |
| 34 | 2021-01-06 | throat irritation |
Patient reported an "itchy throat" described as a "mild reaction". Remained under observation for ...
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Patient reported an "itchy throat" described as a "mild reaction". Remained under observation for additional time, no intervention or additional treatment provided.
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| 34 | 2021-01-06 | fever, chills | Reported Chills and fever of 103F. Symptoms resolved. |
| 34 | 2021-01-06 | shortness of breath, throat pain, headache | Shortness of breath, asthma attack, headache, muscle aches, joint pain, sore throat |
| 34 | 2021-01-06 | head discomfort, headache |
Very mild headache on day of admin of 2nd dose. Difficulty sleeping. Then awoke with intense body ac...
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Very mild headache on day of admin of 2nd dose. Difficulty sleeping. Then awoke with intense body aches at 3am could not go back to sleep. Muscle and joint pain, body aches, and intermittent headache with pressure. Still experiencing.
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| 34 | 2021-01-06 | headache, runny nose, fever, nasal congestion |
tested positive for covid; tested positive for covid; fever; headache; runny nose; nasal congestion;...
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tested positive for covid; tested positive for covid; fever; headache; runny nose; nasal congestion; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first single dose of BNT162B2 (Solution for injection, lot number: EK5730, exp date: Mar2021), intramuscular (injected in left upper arm ) on 20Dec2020 12:30 to 20Dec2020 12:30 at 0.3 mL for immunisation. The vaccine was administered in a hospital and not in a military facility. Medical history included birth control. The patient had no other history. NO ER or physician's office required Prior Vaccinations (within 4 weeks). Patient had no relevant family history. Concomitant medication include unspecified birth control.There was no previous immunization. Patient, who was a Respiratory therapist, got the covid vaccine on 20Dec2020 (Sunday). She first stated she doesn't have any side effects and just had a question. Patient had COVID Symptoms on 26Dec2020 21:00 which was minimal like a runny nose. She further reports that on 26Dec2020 she started to have nasal congestion. On 27Dec2020 the nasal congestion worsened, and she started having a headache. She then experienced a 102.6 fever on 28Dec2020 (Monday). She has since tested positive for Covid on 28Dec2020 11:30. Patient asked if it was ok that she received the 2nd dose after testing positive for covid. Investigation assessment was not performed. There was no prescriber. She received at work because she was a front line healthcare worker. The patient does not have SARS-CoV2 antibodies at diagnosis but never tested for antibodies. The patient was not in the hospital, nor was admitted in ICU. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. No Multiorgan failure. The patient did not receive any additional therapies for COVID-19. The patient did not require the initiation of new medication or other treatment or procedure. PCR on 28Dec2020 (Saturday) Results: just detected. No units available. No reference ranges provided. Standard range was not detected. It was just detected or not detected ranges. No other test or diagnostic imaging performed. The patient had not been treated with immune modulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. No pre-existing diseases worsened during the SARS-CoV2 infection. The patient was recovering from event positive for covid and runny nose; nasal congestion was not recovered and outcome of the other events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.
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| 34 | 2021-01-07 | body temperature increased, chills, fatigue, headache |
12 hours after dose (8 pm), very mild muscle pain and fatigue started. By 10-11, increased whole bod...
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12 hours after dose (8 pm), very mild muscle pain and fatigue started. By 10-11, increased whole body muscle pain, some joint pain, fatigue, and chills began. Chills were pretty bad (for me at least). Almost like increased cold sensitivity. Headache began this morning (24 hours after vaccine). Temp 99.5.
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| 34 | 2021-01-07 | throat pain, shortness of breath |
AWOKE DAY 2 FOLLOWING VACCINE WITH POSSIBLE ALLERGIC REACTION: THROAT SORENESS/TIGHTNESS AND HOARSE ...
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AWOKE DAY 2 FOLLOWING VACCINE WITH POSSIBLE ALLERGIC REACTION: THROAT SORENESS/TIGHTNESS AND HOARSE VOICE, EYES SWOLLEN, ITCHY AND RED. C/O DIFFICULTY BREATHING. DENIED FEVER, CHILLS OR BODY ACHES. MEDICATED WITH BENEDRYL 50 MG AND NO RELIEF. SENT TO ER WITH DIFFICULTY BREATHING.
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| 34 | 2021-01-07 | shortness of breath, throat pain |
Anaphylactic reaction 6 days post vaccine 24Dec2020; I had severe chest tightness; SOB; throat soren...
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Anaphylactic reaction 6 days post vaccine 24Dec2020; I had severe chest tightness; SOB; throat soreness; hoarse voice; mouth swelling; This is a spontaneous report from a contactable physician, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0140), via an unspecified route of administration in the left arm on 18Dec2020 at 15:30 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included severe dust mite allergy (based on skin test). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (MANUFACTURER UNKNOWN), hydrocodone bitartrate/paracetamol (NORCO), ibuprofen (MANUFACTURER UNKNOWN), and ondansetron (ZOFRAN); all for unspecified indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 10:00, 6 days post vaccination, the patient experienced anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling; all reported as life threatening. The events led to an emergency room visit and she was given epinephrine (EPI-PEN), methylprednisolone (SOLUMEDROL), and diphenhydramine hydrochloride (BENADRYL) as treatment. The patient stated that she developed the reactions 45 minutes after she took premedications for a dilatation and curettage procedure. The premedications included ibuprofen, hydrocodone bitartrate/paracetamol, ondansetron. She stated she had taken these medications several times before and this was the first time she had this reaction. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling were recovered on unknown dates.; Sender's Comments: Anaphylactic reactions presented as chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling, developed 45 minutes after premedications including included ibuprofen, hydrocodone bitartrate/paracetamol, ondansetron for a dilatation and curettage procedure and 6 days post vaccination with BNT162B2, the event therefore is most likely attributed to these premedications unrelated to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 34 | 2021-01-07 | shortness of breath, nasal congestion |
Approx 30 minutes after vaccination, started feeling stomach upset, cramping. Approx 1.5 hours after...
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Approx 30 minutes after vaccination, started feeling stomach upset, cramping. Approx 1.5 hours after vaccination, started feeling joint pain. Continued to work until the end of shift 1930. took Benadryl at 32130. Fell asleep; awoke next morning with aches; nasal congestion. Took Sudafed & came to work again (12/18/2020, 0700). Face started itching; then arms @t 0800 but continued working and finished shift. took Benadryl to relieve itching. Awoke early in morning to severe itching. Increased dose of Benadryl and fell asleep. Continued itching on Sat 12/19/2020 and having difficulty breathing. Used inhaler, Pepcid and Prednisone with good effect. Took off work Monday 12/21/2000, Tues 12/22/2020 and Wed 12/23/2020 (no meds taken). Returned to work on 12/24/2020, no fever, no exposure
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| 34 | 2021-01-07 | malaise, dizziness, headache |
Called immunization line and left message. Called client back. Complaining of generally not feeling...
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Called immunization line and left message. Called client back. Complaining of generally not feeling well; extremely dizzy; HA; nausea; vomiting; diarrhea on 1-8-2021
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| 34 | 2021-01-07 | fatigue, malaise, chills, headache | Chills, tiredness, headache, malaise, swelling in arm |
| 34 | 2021-01-07 | fatigue, chills | Fatigue, and chills no treatment initiated. will continue to monitor symptoms |
| 34 | 2021-01-07 | fever, chills |
Fever for 20 hours, acetaminophen Myalgias for 48 hours, acetaminophen headache for 24 hours, acetam...
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Fever for 20 hours, acetaminophen Myalgias for 48 hours, acetaminophen headache for 24 hours, acetaminophen chills for 24 hours, acetaminophen tenderness at injection site for 48 hours, acetaminophen
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| 34 | 2021-01-07 | chills, cough, fever, weakness |
For the first 10 hours I had a sore arm. 10-12 hours I began having weakness, fevers, chills, bodyac...
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For the first 10 hours I had a sore arm. 10-12 hours I began having weakness, fevers, chills, bodyaches, low back pain, intermittent neck pain. Following day I had the same symptoms in addition to left sided axillary lymphadenopathy w/ numbness of L hand 4th & 5th fingers and mild cough. Currently I am about 52 hours post vaccine with left sided axillary lymphadenopathy and intermittent numbness of left 4th and 5th fingers. Other symptoms have improved.
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| 34 | 2021-01-07 | headache, fatigue | Headache, Myalgia, fatigue |
| 34 | 2021-01-07 | headache, dizziness |
Headache, NauseaVomiting, lightheadedness, throat numbness, facial tingling Narrative: 12/28 Onset o...
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Headache, NauseaVomiting, lightheadedness, throat numbness, facial tingling Narrative: 12/28 Onset of lightheadedness within 5 minutes of vaccine followed by nausea. After 35 min she felt tingling on her face and felt like her throat was numb. She drank water with no problem. She checked her O2 sat and it remained 91 - 93%. She just had an O2 meter because her Mother-in-law gave it to her. No underlying lung problem. She continues to have mild nausea but other symptoms have resolved. She has been able to eat some food which is making her feel better. She says she is developing tenderness in her temples which feels like she's developing a headache.
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| 34 | 2021-01-07 | throat pain, headache, fatigue |
January 06, 2021 ?11:50am shot received Right arm ?21:00 right neck pain ?22:00 right ear pain ?22:...
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January 06, 2021 ?11:50am shot received Right arm ?21:00 right neck pain ?22:00 right ear pain ?22:24 right headache and neck pain January 07, 2021 ?07:00 sore throat ?07:00 fatigue, extreme January 8, 2021 ?07:00 fatigue still extreme
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| 34 | 2021-01-07 | fever, fatigue | Myalgia, Fever, Diarrhea, NauseaVomiting, fatigue, legs swelling; |
| 34 | 2021-01-07 | dizziness |
Near syncope; lightheaded/dizzy; vision narrow; Tingling in lips; This is a spontaneous report from ...
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Near syncope; lightheaded/dizzy; vision narrow; Tingling in lips; This is a spontaneous report from a contactable physician. A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), via an unspecified route of administration on 20Dec2020 09:00 in left arm at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced near syncope, lightheaded, dizzy, vision narrow and tingling in lips on 20Dec2020 09:30 AM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment given to the patient for the events. The outcome of the events was recovered on unspecified date. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 34 | 2021-01-07 | shortness of breath, body temperature increased, headache |
On 1/7/2021, I woke up around 0600. I took Allegra and Sudafed. At 0700, I got the shot; waited 30...
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On 1/7/2021, I woke up around 0600. I took Allegra and Sudafed. At 0700, I got the shot; waited 30 min; felt fine and left. At 0745, I started itching and developing a headache (on my drive home). At 0800, restricted breathing; took 50 mg of Benadryl (resolved) and 1000mg acetaminophen for headache (unresolved). At 1200, 99.6 F temp with unresolved headache and felt nausea; took 4mg Zofran. At 1300, took 1000mg acetaminophen; temp was 101 F and stomach felt upset so I didn't want to take ibuprofen At 1900, took 1000mg acetaminophen, temp 100.2F; tried to have some soup; my stomach upset and hurts and feels worse with food At 2200, tempt 99.8 F; stomach hurts; achy; itchy; took 600 mg ibuprofen and 50 mg Benadryl
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| 34 | 2021-01-07 | fatigue |
Severe pain, tenderness and swelling in L axillary, Ibuprofen, Tylenol and warm compress to site eff...
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Severe pain, tenderness and swelling in L axillary, Ibuprofen, Tylenol and warm compress to site effected
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| 34 | 2021-01-07 | dizziness |
Transferred to ED. ED documentation below. Initial Vital Signs [01/06/21 1754] Blood Pressure 146/...
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Transferred to ED. ED documentation below. Initial Vital Signs [01/06/21 1754] Blood Pressure 146/97 Heart Rate 78 Respiratory Rate 16 Temp 36.9 °C (98.4 °F) Temp src Oral SpO2 97 % 34 y.o. female who arrived by From on-campus presented to the emergency department for an allergic reaction to the Pfizer COVID-19 vaccine. Pt received the first round of injections at 1707 tonight and experienced adverse reactions. Pt endorses dizziness which is accompanied by central abdominal pain and itching of her left thigh. Pt states that her throat is dry, but adds that it could be from not drinking much fluids today. Pt has a hx of anaphylaxis from shellfish and angioedema. She says these current symptoms are not similar to the ones she experienced from anaphylaxis or angioedema. Pt has not started or changed any medications, but had an IUD inserted about a week and a half ago. Pt denies any fevers, chills, coughs, cold symptoms, chest pain, palpitations, shortness of breath, headaches, nausea, vomiting, bowel or bladder problems, or urinary complaints. Clinical exam shows central abdominal pain just above the umbilicus with itching of the posterior aspect of the left lateral thigh. Will administer PO Prednisone and PO Diphenhydramine in the ED and observe the pt. No epinephrine injection was deemed necessary at this time. DDx: allergic reaction 1910 hours: Discussed further treatment and vaccine advice with the pt. Will discharge pt to home. Provided follow up instructions to her PCP, for reevaluation. Discussed return precautions. Vital signs are stable at time of discharge.
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| 34 | 2021-01-07 | dizziness, headache |
a left sided nystagmus; urgent MRI showing multiple brain lesions consistent with Acute disseminated...
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a left sided nystagmus; urgent MRI showing multiple brain lesions consistent with Acute disseminated encephalomyelitis; Patient developed paresthesias on entire right side of body / The paresthesias continued, not progressing; a brief headache; episode of dizziness / developed severe dizziness; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) intramuscularly at right arm on 21Dec2020 07:00 at single dose for COVID-19 immunization. Medical history included known allergies to sulfa meds. The patient's concomitant medications included multivitamins [vitamins nos] within 2 weeks of vaccination. Patient developed paresthesias on entire right side of body after a brief headache and episode of dizziness, all since 29Dec2020 15: 00. The paresthesias continued, not progressing, but patient was advised to obtain an MRI Brain and C spine as an outpatient. On 02Jan2021, the patient developed severe dizziness and a left sided nystagmus. She went to the ER and underwent urgent MRI showing multiple brain lesions consistent with acute disseminated encephalomyelitis. Lumbar puncture (LP) was performed, awaiting final results. Patient was admitted and was receiving IV steroids (solumedrol). Duration of hospitalization was 5 days since Dec2020. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures, which included Nasal Swab and Rapid covid swab, both on 02Jan2020 with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on temporal association and lack of other provided etiology, a possible contributory role of suspect BNT162B2 vaccine cannot be excluded for reported acute disseminated encephalomyelitis, paraesthesia, headache, dizziness and nystagmus. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 34 | 2021-01-07 | shortness of breath, throat pain |
employee awoke with throat tightness/soreness, eye swelling, itching and redness. She reports diffi...
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employee awoke with throat tightness/soreness, eye swelling, itching and redness. She reports difficulty breathing and felt like her throat was closing. symptoms are 2 days post vaccination. No fever, chills or body aches. sent was sent to the ER.
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| 34 | 2021-01-07 | shortness of breath | increased heart rate, SOB, Tingling, Hot flushed, Red chest, mouth dry |
| 34 | 2021-01-07 | chills, fatigue, migraine, malaise, fever |
soreness/pain at injection site (had a very hard time utilizing that arm); headache (probably a migr...
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soreness/pain at injection site (had a very hard time utilizing that arm); headache (probably a migraine); nausea; general body aches; chills; low grade temp 100; tired; general feeling unwell; This is a spontaneous report from a contactable health care professional nurse, the patient. A 34-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK9231), intramuscular in the left arm on 31Dec2020 16:15 as a single dose, for COVID-19 vaccination. Medical history included asthma from an unknown date and unknown if ongoing and Know Allergy to Latex. Concomitant medication included budesonide (PULMICORT), albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), magnesium (MAGNESIUM), cyanocobalamin (VIT B12). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 01Jan2021 04:30, the patient experienced soreness/pain at injection site (had a very hard time utilizing that arm), headache (probably a migraine), nausea, general body aches, chills, low grade temp 100, tired, general feeling unwell. No treatment was given for the event. Laboratory test include Body Temperature 100 on an unspecified date. The clinical outcome of Soreness/pain at injection site (had a very hard time utilizing that arm), headache (probably a migraine), nausea, general body aches, chills, low grade temp 100, tired, general feeling unwell recovered Jan2021. .
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| 34 | 2021-01-08 | fatigue |
At around 11:45pm tingling started in my left eyebrow. I thought there was something in my eyebrow a...
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At around 11:45pm tingling started in my left eyebrow. I thought there was something in my eyebrow and after time of wiping it a few times I went to look into the mirror and realized that nothing was there. about and hour later I got a drink and a snack to eat and I realized I had a numb sensation in the left corner of my lip. As a nurse I went though the signs of a stroke with 2 other nurses I called. Everything was normal other than that sensation. Thinking I was just overly tired I went to bed. When I woke up the next day I felt okay until I went to drink some coffee and the numb sensation in my corner lip was still there. Now I was concerned and called employee health and was instructed to go to the ER to role out a stoke. I followed employee health's instructions and went to the ER. I was diagnosed with facial paresthesia and discharged with instructions to come back if symptoms got worse. Symptoms persisted all day and around 7 I called my mom on video chat to show a visual facial twitch on the left side of my face. right after I got off the phone with her the left side of my face drooped and my fiance immediately drove me to the closest ER. I was seen immediately and they decided to admit me. The did labs and head CT. They admitted me to labor and delivery because there were no other rooms. The next day I was seen by a neurologist and many doctors.
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| 34 | 2021-01-08 | headache, fever | Bone pain all throughout, fevers, headaches, stomach pain |
| 34 | 2021-01-08 | fatigue, throat pain |
Developed rash on back and chest/stomach approx 19 hours after injection . Itchy all over Eye itch...
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Developed rash on back and chest/stomach approx 19 hours after injection . Itchy all over Eye itchiness developed 4 hrs after injection Other symptoms were Muscle and body aches Slight cough Sore throat Face puffy Fatigue Chest heaviness (o2 levels stayed 100 percent )
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| 34 | 2021-01-08 | fever |
Fever in the evening of 101.8, following morning fever 101.8. Jan 7th evening fever 100.8. Tylenol t...
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Fever in the evening of 101.8, following morning fever 101.8. Jan 7th evening fever 100.8. Tylenol taken.
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| 34 | 2021-01-08 | fatigue |
I have an infection at the injection site. I believe this could happen with any vaccine but wanted t...
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I have an infection at the injection site. I believe this could happen with any vaccine but wanted to report just in case. I am experiencing a large circle (a little smaller than a baseball) of swollen red skin that is painful around the injection site. Last night, the lymph nodes in my armpit, neck and collar bone on the right side swelled up and were painful. I feel fatigued.
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| 34 | 2021-01-08 | headache | Nausea, intestinal discomfort, lymphadenopathy in right axilla, severe headache |
| 34 | 2021-01-08 | headache, throat pain, fever |
Symptoms started about 3 hours after injection, and worsened over the course of the following 36 hou...
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Symptoms started about 3 hours after injection, and worsened over the course of the following 36 hours. Symptoms include fever (Tmax 104 F) unresponsive to antipyretics, chills, severe myalgias, headache, and sore throat.
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| 34 | 2021-01-08 | headache, somnolence, fatigue, chills |
Vaccinated at 610am. Mild myalgias, pain at injection site, and headache starting around around 430p...
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Vaccinated at 610am. Mild myalgias, pain at injection site, and headache starting around around 430pm when I woke up for work. Severe myalgias, fatigue, worsening headache, pain at injection site and chills noticed around 9pm on 1/8/21 continued until I went to sleep. I slept from 1am 1/9/21 to 230pm 1/9/21. Currently 4pm and experiencing mild generalized myalgias, mild headache, left shoulder and injection site pain and fatigue.
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| 34 | 2021-01-08 | fever, chills, headache | body aches, chills, headache, subjective fever |
| 34 | 2021-01-08 | headache, fever |
fever at 12h and 28h after vaccine, profound body aches (muscle, joint, headaches) that were debilit...
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fever at 12h and 28h after vaccine, profound body aches (muscle, joint, headaches) that were debilitating and could not go to work
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| 34 | 2021-01-09 | dizziness, headache |
1/8/21. Second Pfizer dose. Immediately felt soreness in the arm radiating to the neck. Possible fro...
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1/8/21. Second Pfizer dose. Immediately felt soreness in the arm radiating to the neck. Possible from technique vs actual vaccine 1807 - Neck pain, 3/10, left arm pain 3/10. Left cervical lymph node inflamed 2035 - ringing on right ear 2244 - dizziness 1/9/21. Injection site 1cm diameter bump. Pain in left arm, neck, shoulder 1156 - headache, sharp right parietal 3/10 1730 - pain 8/10 on left upper arm, radiating to lower arm, shoulder, neck. Improved to 4/10 after Advil 800mg once. 1/10/21. Woke up with pain in left arm 7/10. Injection site has induration of 4cm, reddened, warm, tender to touch. Pain improved after Advil 800mg and Tylenol 500mg
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| 34 | 2021-01-09 | headache, chills, fever |
16 hr post injection: sore arm, headache 20 hr post injection: body aches, headache 26 hr post injec...
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16 hr post injection: sore arm, headache 20 hr post injection: body aches, headache 26 hr post injection: body aches increase, chills, fever (Tmax 101.2 36 hr post injection: back to normal baseline state
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| 34 | 2021-01-09 | fatigue, night sweats, fever, migraine | 20 hours after injection: Injection site soreness Fever Night sweats Back pain Fatigue Migraine |
| 34 | 2021-01-09 | migraine, fever, headache, dizziness |
At 6 hours after, I felt very dizzy and had a headache. At hour 12 I have a fever of 100.7, severe b...
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At 6 hours after, I felt very dizzy and had a headache. At hour 12 I have a fever of 100.7, severe body aches, Hips, and knees were the worst. Paid scale would be 8/10. at 16 hours added fever was 102.5 , sever headache over the whole head, at hour 24 same. Hour 36 fever is down to 99.7 however, muscle paid have subsided and migraine is better. Pain scale 3/10
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| 34 | 2021-01-09 | fever, migraine, dizziness, chills |
Fever 102, severe migraine, dizziness, stiff neck, enlarged axillary lymph nodes, chills, body aches...
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Fever 102, severe migraine, dizziness, stiff neck, enlarged axillary lymph nodes, chills, body aches.
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| 34 | 2021-01-09 | chills, fever | Fever, chills. Body aches |
| 34 | 2021-01-09 | headache |
I had headache, joint and body aches. The the night of the 2nd vaccination, I was awoken to what fel...
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I had headache, joint and body aches. The the night of the 2nd vaccination, I was awoken to what felt like electrical jolts in my body. One time I woke up jumping so high of my bed that it felt like I was being tased. I woke up the next morning and felt like electrical currents were running through my body. My right hand had a tremor too
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| 34 | 2021-01-09 | fever, chills, headache | Myalgias x24h Nausea x 18h Chills x36h Fever (Tmax 103.8F) x28h Headache >48h |
| 34 | 2021-01-09 | fever, dizziness, fatigue, sweating |
Sudden onset Severe muscle ache, joint pain, diaphoretic, lightheaded, fever, nausea, fatigue. Appro...
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Sudden onset Severe muscle ache, joint pain, diaphoretic, lightheaded, fever, nausea, fatigue. Approximately 24 hour duration. Acetaminophen administration with resolution of fever but no effect on other symptoms.
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| 34 | 2021-01-10 | nasopharyngitis, throat irritation |
About 10 minutes after vaccination, patient stated her left arm and fingers started burning and feel...
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About 10 minutes after vaccination, patient stated her left arm and fingers started burning and feeling warm. Burning sensation followed up to left side of face. Second dose of injection given on left side. Patient states she has a scratchy throat. Vitals taken at 1311: 98.9, 152/98, HR 80, 99% on room air. 50mg IM Benadryl given at 1312 in right deltoid. Laid patient down on stretcher. Patient also stated she developed cold like symptoms after her first Covid vaccine injection, and tested negative for Covid. Vitals rechecked again at 1322: 130/86, 99% on room air, pulse 75. Told patient to say for another 15 minutes in waiting room. Patient left at 1345. Patient stated the burning and warmness had gone away.
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| 34 | 2021-01-10 | headache, fatigue |
After 1st dose: bad headaches that wouldn't go away with NSAIDS, shoulder blade pain. After 2nd dose...
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After 1st dose: bad headaches that wouldn't go away with NSAIDS, shoulder blade pain. After 2nd dose: bad headaches that wouldn't go away with NSAIDS, chest pain, hot diaphragm, fatigue. She reports still having these symptoms and it is day 4 after the vaccine.
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| 34 | 2021-01-10 | chills, fever, fatigue, sweating, headache |
Chills, sweats, low grade fever, muscle aches, headache, fatigue, nausea. Symptoms started approxima...
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Chills, sweats, low grade fever, muscle aches, headache, fatigue, nausea. Symptoms started approximately 13 hours after vaccination and all resolved after almost 68 hours except for the muscle aches and fatigue.
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| 34 | 2021-01-10 | chills, fatigue, shortness of breath |
Fatigue (ongoing), chills (ongoing), muscle aches (1 day), redness at injection site (3 days), short...
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Fatigue (ongoing), chills (ongoing), muscle aches (1 day), redness at injection site (3 days), shortness of breath (ongoing)
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| 34 | 2021-01-10 | fatigue, fever, headache, chills | Fever of up to 102.9, chills, extreme headache, upper shoulder/lower neck pain. fatigue the next day |
| 34 | 2021-01-10 | chills, fever | Fever, chills, body aches |
| 34 | 2021-01-10 | headache, body temperature increased, malaise, fatigue |
I developed a headache about 1 hour after the vaccine was administered. Two hours later I developed...
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I developed a headache about 1 hour after the vaccine was administered. Two hours later I developed a 100.4 temperature and malaise and body aches. The injection site was swollen, tender to touch and warm. The injection site area remained tender to touch and I was unable to lie on my left side to sleep for over 48 hours. I continued to feel foggy and fatigued for 48 hours. All symptoms have since resolved.
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| 34 | 2021-01-10 | fever, fatigue, headache, malaise |
I developed a headache about 1 hour after the vaccine. I developed a fever of 100.4 about three hour...
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I developed a headache about 1 hour after the vaccine. I developed a fever of 100.4 about three hours after my first dose of the COVID-19 shot. Shortly after this I had moderate GI upset including diarrhea, cramping for about 24 hours. Over the course of 48 hours after the vaccine I had swelling at the injection site, tenderness of the injection area to the point where I was not able to put pressure on the area or sleep on my left side and severe fatigue/malaise. All symptoms resolved after 48 hours. I am a person and wanted the reaction information to be part of the trial data.
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| 34 | 2021-01-10 | chills, fatigue, night sweats, malaise, weakness |
Joint and Muscle aches, chills, Hypersensitivity of skin, Fatigue, weakness, Malise, Sweating in sle...
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Joint and Muscle aches, chills, Hypersensitivity of skin, Fatigue, weakness, Malise, Sweating in sleep
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| 34 | 2021-01-10 | weakness |
Left idiopathic brachial Neuritis with progressive numbness and associated weakness. Distribution in...
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Left idiopathic brachial Neuritis with progressive numbness and associated weakness. Distribution in multiple upper extremity peripheral nerves. Pt was started on High dose steroids with partial and ongoing improvement.
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| 34 | 2021-01-10 | weakness, headache, dizziness | Patient became dizzy, nauseous, weak, and had a headache within 2 hours of vaccination. |
| 34 | 2021-01-10 | shortness of breath, dizziness |
Patient had no issues with the first injection. States she felt like her face was burning, she was h...
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Patient had no issues with the first injection. States she felt like her face was burning, she was having trouble breathing, and felt light headed. Denies any prior anaphylactic reactions, denies vagal experiences after blood draws. Symptoms started within 5 minutes of the vaccination. Vistaril given, patient monitored for one hour in the emergency department with no further incident and returned to work,.
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| 34 | 2021-01-10 | runny nose, headache |
Pfizer-BioNTech COVID-19 Vaccine EUA: Developed headache (about 3 hours after injection), diarrhea (...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Developed headache (about 3 hours after injection), diarrhea (about 20 hours after injection) and sneezing/runny nose (about 4 days and 3 hours after injection)
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| 34 | 2021-01-10 | fatigue, body temperature increased | Reporting a temperature at T 100.2, fatigue and Having bronchospasm |
| 34 | 2021-01-10 | fatigue, fever |
arm pain at site of injection on first vaccine. lasted about 1 week left arm pain at site or inject...
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arm pain at site of injection on first vaccine. lasted about 1 week left arm pain at site or injection, severe fatigue, myalgias and low grade fever after second vaccine that lasted for 48 hours
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| 34 | 2021-01-10 | fever | extreme body aches and fever aprox 24 hours after vaccine, lasting aprox 24 hours |
| 34 | 2021-01-10 | dizziness |
felt a rush of dizziness to my head / felt a little lightheaded all day; heart started racing over 1...
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felt a rush of dizziness to my head / felt a little lightheaded all day; heart started racing over 150 bpm; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140), via an unspecified route of administration in the left arm on 04Jan2021 08:00 at a single dose for COVID-19 immunization. The patient's medical history included overweight and elevated cholesterol. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 04Jan2021 08:00, the patient felt a rush of dizziness to her head a few minutes after receiving the injection and then her heart started racing over 150 bpm. It calmed down after a few minutes although she have felt a little lightheaded all day. No treatment was received for the adverse event. The events were considered non-serious by the reporter.
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| 34 | 2021-01-10 | fever, fatigue |
fever and body aches beginning at 2AM. treated with Ibuprofen with resulting reducting in fever but ...
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fever and body aches beginning at 2AM. treated with Ibuprofen with resulting reducting in fever but continued body aches/myalgias that lasted until 1pm on 1/10/21. Fatigue starting 5pm 1/9 and lasting until 5pm 1/10
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| 34 | 2021-01-10 | fever, chills, headache | fever chills lasted for 12 hours headache nausea |
| 34 | 2021-01-10 | fever | fever, body aches |
| 34 | 2021-01-10 | fever | fever, muscle aches, feels cruddy |
| 34 | 2021-01-11 | cough, throat irritation, shortness of breath, dizziness |
-0715 vaccine administered. -0735 started to feel dizzy/off and right side of tongue felt like it wa...
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-0715 vaccine administered. -0735 started to feel dizzy/off and right side of tongue felt like it was mildly swelling and itchy. -0735 asked to have blood pressure taken as know when I am having anaphylaxis my blood pressure escalates. -0740 took blood pressure and it was 141/86 in right arm. Normal is 110s/60s-70s. No anxiety feelings. -0740 throat started to have increased mucous production. Had the tickle and tightness in throat. Asked and received 25mg Benadryl with cup of water. -0742 started clearing throat frequently and slight cough. Knew it was anaphylaxis and told the team I need to go to the ER. Asked for additional 25mg Benadryl. Also took 20mg Famotidine and 2 puffs Albuterol inhaler--this is my prescribed anaphylaxis routine. Had Epipens on standby. -0743 put on O2 saturation monitor and watched O2 drop into 90-92 range. Asked for epipen on standby as I know when I need to start it. Didn't want to take that when I knew I was about to get it in the ER and knowing self hadn't progressed that far. Felt chest tightness and shortness of breath. Voice started becoming hoarse. -0800 EMS arrived (delay as team didn't know if they were supposed to call 911 or a Code--they chose EMS even though in hospital). Then staff at COVID vaccine clinic kept emphasizing need to go in ambulance while EMS and self fought to go through hospital (much quicker route). Finally cleared to go through hospital to ER. To get some air via breathing in had to sit up leaning forward. Voice completely hoarse by this time. -About 0817 arrived to ER bay. At this time, frequently coughing and cough started to sound stridorous. Difficulty getting breaths in. Had chest pain near heart. Greeted by MD, 2 RNS, and technician. -0819 received IM epinephrine. Attached to 5 lead EKG monitoring and O2 monitoring. Blood pressure done again. Higher than previous. -About 0821 had working IV (previous two attempts failed as veins were constricting). Given IV Solumderol. Started bolus of 1L Normal Saline. -Not sure how long after by cough subsided, increased mucous production subsided, as well as hoarseness decreased. -Held for observation for 2hours (would be longer if not resolved). - Discharged around 1015. At this time, hoarseness almost all gone. Minimal throat clearing. Cough resolved. -Prescribed epipen inhalers (mine expired) and Prednisone. Prednisone is PRN for mild breathing difficulties if it starts again tomorrow 1/13/21. -At 1400 took 50mg Benadryl and 20mg Famotidine as previously prescribed for anaphylaxis maintenance. Will continue this as previously prescribed every 6hours until symptoms stay resolved. -Made follow up appointment with Primary Care Physician per protocol
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| 34 | 2021-01-11 | chills, fever |
40 minutes after the vaccine administration, I experienced numbness on the right side of my face. A...
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40 minutes after the vaccine administration, I experienced numbness on the right side of my face. Around my eye, to the side of my nose and around my mouth, only on the right side. Also on the right side of my tongue. This resolved after an hour and a half. It reoccurred about 6 hours later, at 4:00 p.m. . And continued for 48 hours. 12 hours post vaccine, a fever as high as 102 degrees Fahrenheit, severe body aches targeting especially the lower extremities, and chills occurred. The fever and chills lasted 24 hours. The body ach es lasted 48 hours.
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| 34 | 2021-01-11 | dizziness, throat irritation |
After vaccination patient started complaining of itchy throat. She then stated she was dizzy and th...
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After vaccination patient started complaining of itchy throat. She then stated she was dizzy and that there was a lump in her throat. A few minutes after that she stated it was hard to swallow. She also complained about tingling around her lips and had some swelling of her lips. Pt was then given epinephrine and taken to the emergency room.
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| 34 | 2021-01-11 | fever, weakness, fatigue, headache, nasopharyngitis |
During the overnight hours after recurrent my vaccine i developed fever, cold, and headache. All ...
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During the overnight hours after recurrent my vaccine i developed fever, cold, and headache. All day I have had a low grade fever up to 100.9 as well as headache and weakness/ fatigue.
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| 34 | 2021-01-11 | dizziness |
Feeling of flushing/warmth from head to toe, mild itching throughout body, and dizziness/lightheaded...
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Feeling of flushing/warmth from head to toe, mild itching throughout body, and dizziness/lightheaded. Blood pressure was elevated >180/90, HR 110-120. Gradually decreased and at approximately 30minutes post injection, blood pressure was <145/90 and HR 84. Took 25mg of benadryl approximately 1 1/2 hour after injection time. Symptoms persisted mildly for another 30-45 minutes after benadryl and seem to be gone 5 hours later. Blood pressure 5 hours after was 134/85 which is still a slight elevation from my norm.
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| 34 | 2021-01-11 | headache, fever | Fever, Body aches, muscle aches, headache |
| 34 | 2021-01-11 | weakness |
I feel hot after 15-30 minutes of the injection. I turn red and flush. I feel tingling to my legs an...
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I feel hot after 15-30 minutes of the injection. I turn red and flush. I feel tingling to my legs and arms. And numbness to the left side of my face. I felt like my heart was beating fast. The administrator gave me bendryl. I felt better, but I felt weak. I was able to go home 2 hours after the administration.
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| 34 | 2021-01-11 | throat irritation, throat pain |
I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itchi...
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I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration into the left arm on 30Dec2020 at 11:00 as single dose for an unspecified indication. Medical history included penicillin allergy, sulfa allergy and allergy to nuts from an unspecified date. There were no concomitant medications. The patient experienced allergic reaction, throat pain, swollen uvula, itching in mouth and throat and shaking that was reported as "had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula" on 30Dec2020, at 11:15. The events were reported to have resulted in emergency room/department or urgent care. The events were reported as non-serious. Therapeutic measures were taken as a result of the events: treatment included antihistamine and steroids. Prior to vaccination, the patient had not diagnosed with COVID-19, not had she been tested for COVID-19 since the vaccination. The outcome of events was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
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| 34 | 2021-01-11 | dizziness |
I had dizziness/lightheaded 10 minutes after dose. Dizziness went away 40 minutes later. 24 hours af...
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I had dizziness/lightheaded 10 minutes after dose. Dizziness went away 40 minutes later. 24 hours after dose had body aches. 2 days after dose I had blurred vision in Rt eye and then noticed that Rt eye was fully dilated and Lt eye was normal. Rt eye not responding to light. Went to ED and had 2 CT scans that were normal. They sent me where I had a third CT scan which was normal. I saw ophthalmology and my optic nerve was normal and eyes looked good, but Rt eye still didn't react to light. they ruled out pharmacological and said that it is something neurological. They still don't know exactly what is going on. While at the hospital, I started having urinary retention and now have a foley placed. I have follow ups with neurology, urology and ophthalmology and have orders for MRI of brain and neck.
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| 34 | 2021-01-11 | fever, headache | Low grade fever, headache, body ache |
| 34 | 2021-01-11 | chills, fever, fatigue, dizziness, weakness |
Pain and swelling at injection site, fever, chills, muscle and joint aches, dizziness, weakness, fat...
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Pain and swelling at injection site, fever, chills, muscle and joint aches, dizziness, weakness, fatigue
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| 34 | 2021-01-11 | chills, fatigue |
Patient vaccinated on 1/5/21 in am. Reports onset of symptoms on 1/9/21. Patient says she experien...
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Patient vaccinated on 1/5/21 in am. Reports onset of symptoms on 1/9/21. Patient says she experienced body aches, involuntary head nodding that she describes similar to muscle twitches. Patient reports chills with no fever, nausea and diarrhea that has not stopped. She also described pain in her spine that wrapped around into her chest like a sharp shooting pain and fatigue and a headache that feels like a band wrapped around her head. Symptoms started 1/9/21 and are still present 1/12/21.
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| 34 | 2021-01-11 | chills, headache, fatigue |
Symptoms lasted approximately 12 hours (1.9.21: 0230am - 1430pm) T: 101, chills, moderate muscle/joi...
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Symptoms lasted approximately 12 hours (1.9.21: 0230am - 1430pm) T: 101, chills, moderate muscle/joint aches, fatigue, headache. Took Ibuprofen 400mg x1. 6 weeks pregnant at time of 2nd COVID vaccine dose, estimated date of delivery 9.5.2021.
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| 34 | 2021-01-11 | body temperature increased, fatigue | Temperature to 100.2, sore arm, fatigue |
| 34 | 2021-01-11 | chills, headache | chills, body aches, headaches |
| 34 | 2021-01-11 | chills, fever |
constant ringing in right ear; Myalgia; Fever; Chills; back pain; Inappropriate schedule of vaccine ...
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constant ringing in right ear; Myalgia; Fever; Chills; back pain; Inappropriate schedule of vaccine administered; hearing loss that worsened from before; hearing loss that worsened from before; This is a spontaneous report from a contactable physician (patient). This 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH9899), via an unspecified route of administration, on 04Jan2021 at 08:00AM at single dose for COVID-19 immunisation. The first dose was received on 16Dec2020 at 7:40 AM at single dose. Vaccine location was in the left arm. The patient was vaccinated at hospital, age at vaccination was 34-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included ongoing fluticasone proprionate (FLONASE) for seasonal allergy taking for two years. On 17Dec2020, COVID-19 PCR test was negative. On 04Jan2021 at night, she experienced myalgia, fever, chills, back pain and started with a constant ringing in her right ear and the hearing loss that worsened from before (started on 18Dec2020 after first dose, see AER # 2021012126). Start date of constant ringing in right ear was 05Jan2021. The events resulted in Physician Office visit. Hearing loss in right ear worsened and constant ringing in right ear were reported serious as medically significant while the other events were reported as non-serious. She went to see an ENT doctor and get a hearing test. The hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She is currently being treated with 80mg of Prednisone daily by mouth and getting dexamethasone injections to her middle eardrum. All of these effects have resolved except the hearing loss and ringing in her ear. All the events were considered related to the vaccine per reporter.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 34 | 2021-01-11 | chills, fever |
feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Sore...
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feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Soreness in the left arm; This is a spontaneous report from a contactable Other-HCP. A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EH9899) 16Dec2020 at 07:40AM in the left arm at single dose via intramuscular for COVID-19 immunization. Medical history included seasonal allergy. Concomitant medications included fluticasone propionate for seasonal allergy. The day after vaccination she noticed soreness of the left arm. Then two days later she noticed hearing loss secondary to a feeling of fullness in her ear; it felt like fluid in her right ear which has improved and she states it was not serious after the first dose. Patient received the second dose of vaccine on 04Jan2021 at 08:00AM in the left arm. That night she experienced myalgia, fever, chills, back pain, and started with a constant ringing in her right ear and the hearing loss that worsened from before (reported under AER 2021012152. All of these effects have resolved except the hearing loss and ringing in her ear. Additionally she went to see an ENT doctor and get a hearing test. The Hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She was currently being treated with 80mg of Prednisone daily by mouth and getting Dexamethasone injections to her middle eardrum. Patient informed that on 17Dec2020 she was tested for COVID 19 with the PCR test due to an exposure at work. The result was negative. The patient recovered from soreness in the left arm on 19Dec2020. The patient had not yet recovered from deafness.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events ear congestion and hearing loss unilateral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 34 | 2021-01-12 | headache, fatigue |
1/7/21 Patient reported that she had an immune system response a week after she received the Covid v...
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1/7/21 Patient reported that she had an immune system response a week after she received the Covid vaccine on 12/22/20 that sent her into a Lupus flare up. Her Lupus had been under control, but this was the worst flare-ups that she has had. She said she could not even move and her husband had to pick her up. She had head to toe joint pain and rated this a 10. She also had had headache and extreme fatigue. She saw a physician and she was tested for Covid, strep and influenza, which were all negative. She was prescribed emergency steroids. She did not miss any work because she was on scheduled PTO time. Saw her Rheumatologist ion 1/6 and her hydroxy-chloroquine dose was doubled.
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| 34 | 2021-01-12 | chills, cough, headache, fever |
14 hrs after vaccine developed fever, headache, chills, cough, and severe all over body aches. Mond...
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14 hrs after vaccine developed fever, headache, chills, cough, and severe all over body aches. Monday 1/11 through today 1/13 still feeling feverish with chills and body aches but no actual fever and deep dull back pain that is making me vomit. Also injection site redness started 48hrs after vaccine and only continues to worsen and spread each day still today 1/13. Have been taking Tylenol, Motrin, antihistamine, and at times Zofran.
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| 34 | 2021-01-12 | chills, fatigue, fever |
8-10 hours following vaccine: Myalgia throughout body, severe pain at injection site - unable to rai...
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8-10 hours following vaccine: Myalgia throughout body, severe pain at injection site - unable to raise arm above shoulder level and painful to move and touch. (resolved) 3 days following vaccine: Sudden onset chills, fever of 101.1, myalgia throughout body and fatigue. I slept for 14 hours straight, still have slight fever of 99.6 and some myalgia, but mostly resolved.
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| 34 | 2021-01-12 | fever, fatigue, dizziness, influenza like illness |
After 1st dose : flu like symptoms two days with facial bilateral cheek numbness lasting two weeks ...
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After 1st dose : flu like symptoms two days with facial bilateral cheek numbness lasting two weeks After 2nd dose : lightheaded myalgia fever axillary lymph node swelling and redness, nausea, body aches for two days. Still on day four currently : lightheaded/severe dizziness and fatigue
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| 34 | 2021-01-12 | headache, chills, fatigue, fever |
All of these symptoms began on 1/13/21: Chills, headache, fever (100.2-101.0 deg F), nausea, body ac...
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All of these symptoms began on 1/13/21: Chills, headache, fever (100.2-101.0 deg F), nausea, body aches, chest pressure, metal taste in my mouth, fatigue
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| 34 | 2021-01-12 | chills, fatigue, headache |
Approximately 16 hours after injection, experienced body aches, chills, severe headache and fatigue....
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Approximately 16 hours after injection, experienced body aches, chills, severe headache and fatigue. Symptoms resolved after approximately 14 hours later.
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| 34 | 2021-01-12 | sweating, chills, dizziness, fatigue, headache |
Beginning 12 hours after my 2nd dose, I woke up with myalgias, chills, and drenching sweats on 1/9. ...
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Beginning 12 hours after my 2nd dose, I woke up with myalgias, chills, and drenching sweats on 1/9. Later that morning 6:30am, I developed severe fatigue, dizziness upon standing and walking, a L sided headache, L sided arm pain extending from elbow to sternocleidomastoid muscles on the L side, and axillary lymphadenopathy in the same arm as the vaccine (left). I took 650mg of Tylenol and went to work. Walking at a normal pace, my heart rate was 145. At rest inside the hospital it was in the 110s (measured by watch). the headache lasted all day on 1/9 and 1/10 and my neck felt slightly stiff (it was difficult to turn my head to look at traffic behind while driving). I took additional doses of Tylenol on 1/9 and 1/10 and by the AM of 1/11, all of my symptoms had resolved except for the L axillary lymphadenopathy.
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| 34 | 2021-01-12 | fever, chills |
Fever, chills - no treatment, ongoing. Symptoms started approximately 18 hours after vaccine was giv...
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Fever, chills - no treatment, ongoing. Symptoms started approximately 18 hours after vaccine was given.
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| 34 | 2021-01-12 | fever | Fever, myalgia, tachycardia |
| 34 | 2021-01-12 | headache, fever |
Fever; headache; body aches; This is a spontaneous report from a non-contactable other healthcare pr...
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Fever; headache; body aches; This is a spontaneous report from a non-contactable other healthcare professional reporting for herself. A 34-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231), via an unspecified route of administration on 05Jan2021 14:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (results unknown). The patient experienced fever, headache, body aches an unspecified date in Jan2021. Event outcome was unknown. The reporter assessed the events as non-serious. No follow up attempts are possible. No further information is expected.
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| 34 | 2021-01-12 | malaise |
First started with lots of muscle soreness of arm where vaccine was placed, a few bumps that were it...
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First started with lots of muscle soreness of arm where vaccine was placed, a few bumps that were itchy developed that same afternoon, more bumps appeared next day accompanied by malaise and itching sporadically. By 24 hours, rash and bumps were more prevalent and lots of itching which progressed rapidly through night and hives developed even with antihistamine.
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| 34 | 2021-01-12 | chills, fever |
Got shot at 10AM. Woke up at 3AM with chills, muscle aches, joint pain, and a fever of 100.7. These ...
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Got shot at 10AM. Woke up at 3AM with chills, muscle aches, joint pain, and a fever of 100.7. These subsided somewhat with advil and tylenol. The chills, fever seemed to go away after 24 hours. Muscle aches/joint pain continued 48+ hours after. I was unable to go to work or care for my child due to symptoms.
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| 34 | 2021-01-12 | headache, fatigue | Headache, L arm soreness, full body muscle pain, full body joint pain, severe fatigue, diarrhea |
| 34 | 2021-01-12 | headache, fever |
Hives to bilateral breasts, self resolved after 3-4 hours (Have bilateral silicone breast implants)....
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Hives to bilateral breasts, self resolved after 3-4 hours (Have bilateral silicone breast implants). Patient also had fever, body aches and headache.
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| 34 | 2021-01-12 | chills |
I had arm pain in the left arm that lasted for 2 hours, chills, abd pain, nausea, muscle aches & mal...
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I had arm pain in the left arm that lasted for 2 hours, chills, abd pain, nausea, muscle aches & malays. My estimated date of deliver is 03/05/2021 and I am 32 weeks gestation.
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| 34 | 2021-01-12 | sweating |
I had the vaccine at 12:23 PM and felt fine. At 2 am that same night I woke up sweating and my left ...
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I had the vaccine at 12:23 PM and felt fine. At 2 am that same night I woke up sweating and my left side of my face was numb and tingling. I am able to move it but is continuing to tingle only on my left side. My lips, the very side of my tongue, my bottom jaw and my check bone constantly tingle and feel numb, when I talk some spit comes out on that side and my side of my nose also feels numb. As time goes on it isn't getting any better but not much worse. today my bottom lip just feels more numb
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| 34 | 2021-01-12 | headache, fatigue |
LUE pain at injection site, muscle spasms of left arm, numbness and tingling of left hand, episode o...
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LUE pain at injection site, muscle spasms of left arm, numbness and tingling of left hand, episode of burning across chest x 1 when symptoms first started. Brief period of muscle spasms along left neck, back left arm and left lower extremity on first day of vaccination. Brief episode of right hand numbness and tingling. On day 2 very flushed and hot feeling, temp 37.9 at 1am on 01/12/21. Sever muscle spasms and pain from left trapezius to sternocleidomastoid, to left upper extremity, left thorax and abdomen to left lower extremity with extreme fatigue. Headache throughout day. Now with residual left lower extremity numbness and tingling, pain improved and muscle spasm frequency decreasing although episode of chest pain with muscle spasm did occur yesterday evening. At this point the left lower extremity tingling is most worrisome. Muscle spasms and pain slightly improved.
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| 34 | 2021-01-12 | chills, fatigue, chills, fever, fever, fatigue | Muscle ache, fever, chills, fatigue. Improving. |
| 34 | 2021-01-12 | fatigue, fever, chills |
Myalgias, subjective fever, fatigue, chills from hours 12 to about 40 Pregnant: due date March 7, 2...
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Myalgias, subjective fever, fatigue, chills from hours 12 to about 40 Pregnant: due date March 7, 2021.
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| 34 | 2021-01-12 | discomfort, fatigue, chills |
Patient reports to clinic after receiving the COVID-19 Vaccine at today. Patient states that she was...
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Patient reports to clinic after receiving the COVID-19 Vaccine at today. Patient states that she was given the vaccine at 0915 today and about 5 mins after started to have symptoms of a hot sensation from head to toe, heart racing, ears burning, and chest tightness, no breathing difficulty. Patient notified staff and was given O2 and allowed to drink her water. Her symptoms did improve and she was sent to the waiting area again. After about 10 mins her chest tightness came back. Patient states she can feel her blood flowing, "kinda like when your limb is numb". Patient also had symptoms of chills, body shakes, loss of smell, and a metallic taste in mouth. Patient states that she was seen again by staff and laid on a cot for 20 mins, and was then cleared to head back to work around 1000. Patient was seen in the clinic at 1157, and her symptoms since it started have improved. Currently she has the following symptoms: can't taste/smell, (L) arm is sore, H/A, with constant ache, localized to back of neck up to behind the both eyes. Body feels worn out, everything feels heavy, takes a few second to focus when she looks around "like there is a delay". Patient was sent home to recover and to let medical staff know if her symptoms return.
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| 34 | 2021-01-12 | shortness of breath, cough, throat irritation |
Pfizer Vaccine; Cough, SOB, uvula swelling, tachycardic, hot flashes, facial tingling and itching, "...
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Pfizer Vaccine; Cough, SOB, uvula swelling, tachycardic, hot flashes, facial tingling and itching, "cotton ball" in back of throat, dry mouth; administered Epinephrine 0.3 mg IM x3, solumedrol 125 mg, diphenydramine IV 50 mg and 25 mg, famotidine 20 mg, racemic epi, ativan; reaction started 5 min after dose; discharged with epi pen and prednisone
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| 34 | 2021-01-12 | headache, fever, dizziness, fatigue, chills, night sweats |
Post shot: 1/11/21 10pm I had a headache and mild chills 1/12/21 12am-2am chills and rigors without...
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Post shot: 1/11/21 10pm I had a headache and mild chills 1/12/21 12am-2am chills and rigors without fever 2am-6am fever, chills with rigors at time, nausea, headache, joint pain, fatigue, dizziness, double vision, drenching night sweats 6am-11pm continuing mild fevers and chills without rigors , joint pain, nausea, headache. Last fever was approx 6pm that day but the chills continued 1/13/21 12am-6am chills and fatigue. No fevers. Drenching night sweats 6am- present fatigue and slight headache Motrin was able to help the fevers and I stay well hydrated
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| 34 | 2021-01-12 | sweating, dizziness |
Pt experienced tachycardia, lightheaded, sweaty, nausea, and near syncope. Pt says she is anxious a...
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Pt experienced tachycardia, lightheaded, sweaty, nausea, and near syncope. Pt says she is anxious and feels this was anxiety-related.
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| 34 | 2021-01-12 | headache, chills |
The patient became nauseated within 1 hour of the vaccination, then had an emesis and was nauseated...
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The patient became nauseated within 1 hour of the vaccination, then had an emesis and was nauseated for the remainder of the day. Also reported chills, and severe headache.
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| 34 | 2021-01-12 | throat swelling |
Throat felt "fuzzy" and slightly swollen approximately 10 minutes post vaccination, seen in ED, give...
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Throat felt "fuzzy" and slightly swollen approximately 10 minutes post vaccination, seen in ED, given benadryl, IV, famotidine, ondansetron, metylprednisolone and discharged to home
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| 34 | 2021-01-12 | headache | Vertigo and headache for 8 days |
| 34 | 2021-01-12 | fever, chills | aches, chills, fever |
| 34 | 2021-01-12 | chills |
arm soreness day after vaccine, developed full body aches/chills about 25 hours later that lasted ap...
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arm soreness day after vaccine, developed full body aches/chills about 25 hours later that lasted approximately 2 hours then passed.
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| 34 | 2021-01-12 | sweating, chills | chills, sweats, nausea and body aches for 24 hours |
| 34 | 2021-01-12 | dizziness | dizziness, tingling in face to neck and nausea; rested and refused emergency department |
| 34 | 2021-01-12 | fever, chills |
received dose #2 shot at 10AM on 1/11. Woke up at 3AM on 1/12 with chills, fever, muscle and joint ...
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received dose #2 shot at 10AM on 1/11. Woke up at 3AM on 1/12 with chills, fever, muscle and joint aches/pains. Tylenol and ibuprofen helped relieve symptoms partially. After 24 hours, fever was gone. Muscle aches/join pain persisted after 48 hours post vaccine.
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| 34 | 2021-01-13 | chills, migraine, fever |
1/07@1920 INJECTION RECEIVED 1/8 @ 1100 CHILLS BEGAN @1130 102 FEVER RECORED; 1000MG ACETAM...
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1/07@1920 INJECTION RECEIVED 1/8 @ 1100 CHILLS BEGAN @1130 102 FEVER RECORED; 1000MG ACETAMINOPHEN TAKEN @1300 MIGRAIN BEGAN @1700 NAUSEA BEGAN @1900 CHEST PAIN STARTED @2100 WENT TO THE ER
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| 34 | 2021-01-13 | fatigue |
12/31/2020Asthma Wheezing. 1/3/2021 Increase severity for chocolate allergies. Haven?t improve Fat...
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12/31/2020Asthma Wheezing. 1/3/2021 Increase severity for chocolate allergies. Haven?t improve Fatigue and tiredness 1/3-1/5/2021
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| 34 | 2021-01-13 | headache, fatigue |
Body aches, swelling at the injection site, headache, fatigue, and trouble maintaining temperature. ...
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Body aches, swelling at the injection site, headache, fatigue, and trouble maintaining temperature. All symptoms subsided within 48 hrs except for the swelling at the injection site.
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| 34 | 2021-01-13 | chills, fatigue, fever | Chills, low grade fever, injection site soreness, fatigue and muscle aches |
| 34 | 2021-01-13 | fatigue, headache, fever, sweating, chills |
Headache, fever, chills, nausea, drenching sweat, extreme body aches, fatigue. Swollen clavicle and...
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Headache, fever, chills, nausea, drenching sweat, extreme body aches, fatigue. Swollen clavicle and axillary lymph nodes bilateral.
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| 34 | 2021-01-13 | dizziness, chills, fever, fatigue, headache |
Headache; dizziness; body aches; mild fever; chills; extreme fatigue; soreness at injection site; Th...
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Headache; dizziness; body aches; mild fever; chills; extreme fatigue; soreness at injection site; This is a spontaneous report from a contactable other HCP (patient). A 34-year-old non-pregnant female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 07Jan2021 at 10:45 at single dose in left arm for covid-19 immunization. Medical history included allergies to penicillin. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING), levothyroxine, desvenlafaxine succinate (PRISTIQ). The patient previously received the first dose bnt162b2 (Batch/lot number: EK5730) on 17Dec2020 at 15:00 in left arm for COVID-19 immunization at age of 33 years old. The patient experienced headache, dizziness, body aches, mild fever, chills, extreme fatigue, and soreness at injection site on 07Jan2021 at 23:00. All events were reported as non-serious by reporter. The patient didn't receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 since the vaccination. The outcome of all the events was resolved in Jan2021. No follow-up attempts are possible. No further information is expected.
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| 34 | 2021-01-13 | cold sweat, sweating, dizziness |
Hypotension 91/71 with orthostatic hypotension <80 SBP ( my BP cuff doesn?t read lower than that). N...
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Hypotension 91/71 with orthostatic hypotension <80 SBP ( my BP cuff doesn?t read lower than that). Near syncope at 0615. Loss of vision, tinnitus, lowered to the ground and followed by nausea and sweating. Resolved in minutes. Continue to be dizzy today with clammy and dizzy upon standing
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| 34 | 2021-01-13 | headache |
I had heart palpitations and headache started at about 11 am. I didn't say anything for about an ho...
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I had heart palpitations and headache started at about 11 am. I didn't say anything for about an hour to see if they passed. At noon, I asked to be evaluated. They did an EKG. Normal. Took Ibuprofen and Tylenol . Sent me home to rest for the day. Slept 2:30 pm to 6 am the next day. The symptoms were resolved when I awoke.
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| 34 | 2021-01-13 | skin warm, headache, fever, chills |
I started experiencing soreness to left arm about 1-2 hours after injection but nothing else. I went...
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I started experiencing soreness to left arm about 1-2 hours after injection but nothing else. I went to bed around 11pm. Then I was woken up in the night around 3am violently shaking, teeth shattering and unable to even stand straight from shaking so bad. I felt like I was freezing but skin was hot to touch. I didn't have a thermometer to take temperature at that time because it was in another family member's room. I felt nauseated as well. I took 600mg ibuprofen and tried to lay back down. At 3:59am my aunt woke and brought the thermometer downstairs. I could tell the ibuprofen was working some and fever was less as the shaking had calmed. I was able to check my temperature and it was 100.8F (an hour after the ibuprofen). I still took 100mg tylenol at that time. As of this morning (after 7am) I am sore all over, tired and have a headache, temp 99.2F.
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| 34 | 2021-01-13 | body temperature increased | L arm pain and numbness from injection site to shoulder, temp 99.0-99.5 F |
| 34 | 2021-01-13 | fever, headache | Low-grade fever, bodyaches, slight headache |
| 34 | 2021-01-13 | weakness, headache | Muscle aches, joint pain, headache, nausea, weakness. Lasted ~24 hours. |
| 34 | 2021-01-13 | sweating, chills, headache |
Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea....
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Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Sunday had emergency appendectomy for actuate appendicitis.; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Post surgery had allergic reaction unknown reason with head to toe rash; Post surgery had allergic reaction unknown reason with head to toe rash; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular (lot number: EL1283) on left arm on 08Jan2021 at 6:30 AM at single dose for covid-19 immunisation. The relevant medical history included celiac, anemia, known allergies: Sulfa and Gluten. Concomitant medications were not reported. The patient received first dose of BNT162B2 via intramuscular (lot number: Ek5730) on left leg on 18Dec2020 at 11:00 AM at single dose for covid-19 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat. On Saturday the patient had sweating, chills, headache, nausea. On Sunday had emergency appendectomy for actuate appendicitis. Post surgery had allergic reaction unknown reason with head to toe rash. It was also reported that the adverse event started on 08Jan2021 at 03: 15 PM (as reported). The patient had 1-day hospitalization. The patient received treatment for the events. The adverse events resulted in Emergency room/department or urgent care. The events were reported as serious due to life threatening and hospitalization. The most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. Medications administered during appendectomy may confound reactions experienced post-surgery. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 34 | 2021-01-13 | fatigue, chills, sweating |
Sore arm around 1300. Fatigue around 1600. Chills at 2300, relieved by 2 tabs tyelenol. Woke up at 3...
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Sore arm around 1300. Fatigue around 1600. Chills at 2300, relieved by 2 tabs tyelenol. Woke up at 300 next morning in hot sweat. Next day 1/12, body tension from chills precious night- relieved by advil. fatigue from poor nights sleep.
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| 34 | 2021-01-13 | dizziness | Systemic: dizzy, tachycardic (132), bp high 137/88 |
| 34 | 2021-01-13 | fever, headache, shortness of breath |
The patient had an ongoing medical history of Crohn's disease/Concomitant medication included vedoli...
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The patient had an ongoing medical history of Crohn's disease/Concomitant medication included vedolizumab (ENTYVIO) for Crohn's disease; shortness of breath; difficulty swallowing; fever; headache; nausea; she was feeling as if her throat was closing; Chest tightness; This is a spontaneous report from a contactable physician reporting for a patient. A 34-year-old female patient received the first dose of BNT162B2 (COIVD-19 Vaccine) , via an unspecified route of administration on 03Jan2021 at single dose for covid-19 immunisation. Medical history included Crohn's disease from an unknown date and unknown if ongoing, COVID-19 in 2020 to an unknown date and unknown if ongoing. Concomitant medication included vedolizumab (ENTYVIO) for Crohn's disease. The reporter is a physician who is reporting and AE for a patient who received the vaccine and subsequently developed symptoms including short of breath, fever, headache, nausea, difficulty swallowing with seriousness criteria of Medically significant on 03Jan2021. The patient self-medicated with benadryl and symptoms resolved briefly but then went to urgent care with re-occurring symptoms and was prescribed prednisone. Caller states the patient's symptoms have resolved. She is calling to get more information to determine if the patient should receive the second dose. The reporter further stated that she has a patient who received her first shot, clarified as the COVID-19 Vaccine. About an hour and 45 minutes later, the patient had shortness of breath and then later had a fever, headache and nausea. It was later that night when the patient had a fever. The patient had difficulty swallowing which worsen; she was feeling as if her throat was closing. The patient is a nurse, so she self medicated with Benadryl. After taking the Benadryl, the patient was better in the early morning. When the doctor's office opened, the patient called and was having similar symptoms, clarified as all the symptoms mentioned above. The patient went to the urgent care where she received more Benadryl and was started on prednisone. Caller did not know the dose of prednisone the patient had received. After that, the patient started feeling better. The patient's second dose of the COVID19 Vaccine is due around 24 to 26Jan2021. The patient has not called the doctor/caller back. The caller assumes that the patient has recovered but could not be certain. Caller added that the patient also experienced chest tightness when she was having shortness of breath. The patient's fever was 101 on 03Jan2021. The patient was not drooling with her difficulty swallowing. Caller stated that the patient had a positive COVID test earlier, she thinks it was maybe 3 to 4 months ago (in 2020). The patient has not received another COVID test since she received the first dose of the COVID-19 vaccine to the caller's knowledge. Reporting physician is an internal medicine physician. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported short of breath, fever, headache, nausea, difficulty swallowing, throat closing, chest tightness, and the administration of COVID 19 vaccine, BNT162B2, based on the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 34 | 2021-01-13 | weakness, headache |
Weakness, muscle aches, headache, nausea, Had same reaction after 1st dose. More severe after 2nd do...
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Weakness, muscle aches, headache, nausea, Had same reaction after 1st dose. More severe after 2nd dose but improving.
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| 34 | 2021-01-13 | fever, night sweats, dizziness |
feverish; lightheaded; tingling in my fingers; night sweats; This is a spontaneous report from a con...
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feverish; lightheaded; tingling in my fingers; night sweats; This is a spontaneous report from a contactable other hcp. A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), intramuscular in left hand on 30Dec2020 14:15 at a single dose for COVID-19 immunization. Vaccination occurred in a Nursing Home/Senior Living Facility. The patient's medical history was not reported. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C), colecalciferol (VITAMIN D), and zinc (ZINC). The patient was feverish, lightheaded, had tingling in fingers and had night sweats on 01Jan2021 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test-nasal swab with a negative result on 04Jan2021. Information on the lot/batch number has been requested.
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| 34 | 2021-01-13 | fatigue, headache |
swollen lymph nodes to left arm pit; headache; fatigue; severe neck pain; This is a spontaneous repo...
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swollen lymph nodes to left arm pit; headache; fatigue; severe neck pain; This is a spontaneous report from a contactable health care professional (nurse), the patient. A 34-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: eha899), in the left arm on 06-JAN-2021 12:00 as a single dose, for COVID-19 vaccination. The most recent COVID-19 vaccine was administered was a Nursing Home/Senior Living Facility. Medical history included covid-19 (prior to vaccination) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medication included duloxetine hydrochloride (CYMBALTA), omeprazole (PROTONIX [OMEPRAZOLE]). On 07-JAN-2021 05:00, The patient experienced swollen lymph nodes to left arm pit, headache, fatigue, severe neck pain.. No treatment was given for the event. . No other vaccines were given within 4 weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of swollen lymph nodes to left arm pit, headache, fatigue and severe neck pain.was not recovered.
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| 34 | 2021-01-14 | chills, migraine, headache, dizziness |
1/14/21- 6am - migraine, dizziness, nausea 1/14/21 - 9am - chills, body aches Lasted all day into 1/...
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1/14/21- 6am - migraine, dizziness, nausea 1/14/21 - 9am - chills, body aches Lasted all day into 1/15/21 1/15/21 - 6am -mild headache and body aches, seems to be getting better
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| 34 | 2021-01-14 | chills, fever, headache |
101.5 (units not reported) fever; Severe body aches; chills; headache; This is a spontaneous report ...
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101.5 (units not reported) fever; Severe body aches; chills; headache; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in the left arm from 07Jan2021 to 07Jan2021 at SINGLE DOSE, for covid-19 immunization. The patient 's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 for covid-19 immunization on unspecified date (1st dose). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 08Jan2021 about 24 hours post vaccine, the patient experienced a 101.5 (units not reported) fever, severe body aches and chills. The outcome of events was unknown. No treatment was required or given due to the events. No follow-up attempts possible. No further information expected. Information on the batch/lot number has been requested.
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| 34 | 2021-01-14 | headache, pneumonia, runny nose, respiratory tract congestion, shortness of breath |
12/22 evening I had severe arm soreness and light body aches, the next morning I felt congestion, ru...
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12/22 evening I had severe arm soreness and light body aches, the next morning I felt congestion, runny nose , severe headache, mild palpitations, my whole body hurt. 12/24 I couldn't breathe through my nose at all , no taste or smell for 24 hours, 1 week after I wasn't getting better my lungs sounded junky , 12/31 I went to the urgent care, I got tested and was negative, I had pneumonia , I was sent home with antibiotic, steroids, inhaler.
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| 34 | 2021-01-14 | fatigue, chills, headache, malaise, fever |
Covid19 second vaccination adverse reaction: Received vaccination at 0815am Tuesday 1/12. By 6pm, on...
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Covid19 second vaccination adverse reaction: Received vaccination at 0815am Tuesday 1/12. By 6pm, onset of rigors/chills, body aches, generalized malaise, fatigue, headache which lasted until Wednesday 1/13 ~11:30pm (only x1 low grade fever 99.2 ~6pm Wednesday). Thursday 1/14 called out sick from work residual exhaustion/fatigue and minor headache, body aches dissipated. Able to return to work Friday 1/15.
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| 34 | 2021-01-14 | chills, fatigue, headache, sweating, fever |
Day of shot took prophylactic ibu and took as well Tuesday am. By Tuesday at 2-3 pm 1 day post shot-...
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Day of shot took prophylactic ibu and took as well Tuesday am. By Tuesday at 2-3 pm 1 day post shot- felt poor (similar to first shot- headache, tired). By 4 pm felt like getting fever. Finished shift got home by 5 o'clock fever 101. Restarted ibu laid down. By 12 pm terrible chills sweats fever now up to 102.8. By Wednesday morning at 101. Went back down to normal by afternoon but still felt very tired with splitting headache. By 4 fever returned almost at 101. Thursday fever free without meds. Today (Friday) fever free without meds- just tired.
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| 34 | 2021-01-14 | headache, fatigue, fever |
Developed low grade fever (99.3F), fatigue, aches, headache around 6pm on 01/13/2020. Treated with ...
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Developed low grade fever (99.3F), fatigue, aches, headache around 6pm on 01/13/2020. Treated with OTC Aleve. All resolved within 12 hours except the fatigue. Also noticed painful axillary lymph node swelling on 01/13/2020 upon waking at 6:30am. Treating with OTC Aleve.
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| 34 | 2021-01-14 | dizziness |
Lightheaded; Tachycardia; Blotchy rash; This is a spontaneous report from a contactable nurse (patie...
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Lightheaded; Tachycardia; Blotchy rash; This is a spontaneous report from a contactable nurse (patient herself). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: Ek9231, expiration date was unknown), intramuscularly on the left arm on 08Jan2021 (at 11:00 PM as reported; pending clarification) at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included that the patient had known allergies to medications, food, or other products, but was not specified. Concomitant medications included ascorbic acid (VITAMIN C), ergocalciferol (VITAMIN D), curcuma longa (TURMERIC) as supplement, and an unspecified multivitamin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Jan2021 (at 11:15 AM as reported; pending clarification), the patient experienced lightheaded, tachycardia, and blotchy rash, which resulted in an emergency room/department or urgent care visit. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of lightheaded, tachycardia, and blotchy rash, which included diphenhydramine (BENADRYL) and steroid. The patient was recovering from all the events.
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| 34 | 2021-01-14 | fatigue, dizziness, headache |
Long lasting throbbing headache like non other, nose bleed, numbness on right arm, right shoulder, r...
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Long lasting throbbing headache like non other, nose bleed, numbness on right arm, right shoulder, right cheek & face, muscle aches, fatigue, and tingling on forehead. Also felt dizzy.
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| 34 | 2021-01-14 | dizziness, headache, head discomfort |
Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Mus...
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Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; This is a spontaneous report from other health professional. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1686, via an unspecified route of administration from 06Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included Sulfa sensitivity (but allergy not confirmed). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899, from 18Dec2020 for covid-19 immunization (1st dose). Concomitant medication included lisdexamfetamine mesilate (VYVANSE) and drospirenone, ethinylestradiol (OCELLA), drospirenone, ethinylestradiol (YASMIN). On 06Jan2021 12:00, the patient experienced muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo. The patient underwent lab tests and procedures on 26Aug2020 which included Nasal Swab/ Covid test with negative result; then on 18Dec2020, COVID Antibody Test and COVID Antibody Test both with negative results. The outcome of event was not recovered. No treatment was received/required due to the events. No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
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| 34 | 2021-01-14 | dizziness, influenza like illness |
Patient received second Pfizer COVID-19 vaccination on 1/7/2021. On 1/8/21 developed nausea, flu-lik...
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Patient received second Pfizer COVID-19 vaccination on 1/7/2021. On 1/8/21 developed nausea, flu-like symptoms, dizziness. While walking down stairs became dizzy and fell, injured R shoulder. Presented to urgent care 1/9/21 for shoulder workup, all symptoms of vaccine reaction had resolved. No OTC medications taken for vaccine reaction.
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| 34 | 2021-01-14 | headache, fatigue, chills |
Pfizer-BioNTech COVID-19 Vaccine EUA injection site pain, minor nausea, minor headache starting 4 ho...
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Pfizer-BioNTech COVID-19 Vaccine EUA injection site pain, minor nausea, minor headache starting 4 hours after vaccine administration injection site pain, fatigue, worsening headache, body aches (muscle pain), chills, worsening nausea starting approximately 30 hours after vaccine administration
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| 34 | 2021-01-14 | weakness |
Reaction started 40min after injection. It started with tingling above the lips and then numbness o...
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Reaction started 40min after injection. It started with tingling above the lips and then numbness on the whole face + redness on face and neck per coworker, then collapsed trying to go to the bathroom to look at the redness, then had generalized weakness for about 45 minutes (couldn't move at all or open mouth and eyes). I was finally able to open my eyes 1 hour after it started. Got discharged 2 hours after symptoms resolution. No medication was needed, symptoms gradually faded away.
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| 34 | 2021-01-14 | fever, chills, headache |
Starting about 12 hours after vaccine I had the expected symptoms of body aches, chills, headache, n...
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Starting about 12 hours after vaccine I had the expected symptoms of body aches, chills, headache, nausea and low grade temps. At ~ 0500 on 1/14/21 (~18 hrs after vaccine), I woke up as I was in SVT. I was not able to convert myself and had to go to ED for treatment. HR was 232 upon arrival to ED. Prior to administering adenosine, SVT resolved on own. SVT episode lasted ~2hrs. I have not had a prolonged SVT episode since ablation in 2016. ER doc mentioned that perhaps fever/ illness from vaccine lowered my threshold for going into SVT.
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| 34 | 2021-01-14 | fever, chills, fatigue |
Symptoms ? EE reports around 10:00 PM on 1/13 pain and achiness to R arm and tired. EE reports woke...
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Symptoms ? EE reports around 10:00 PM on 1/13 pain and achiness to R arm and tired. EE reports woke up Thursday am with fever (Tmax 103) and chills. EE reports temp 99 at time of call. ? Last day of work and shift ? Friday (1/8/21) Home remedies? - Tylenol and motrin q4h, rest Any improvement? ? mild improvement Recommendation? EE encouraged to take ibuprofen and acetaminophen as outlined in the Medical Directive and to apply a cold compress to injection site. EE encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. EE reports she called out of work today. EE educated to manage her RTW according to the Workplace policy. EE said she had a secondary exposure and requested to be tested through hospital but was told by EH unable to test so got COVID tested on Monday 1/11 at pharmacy and reports negative result. EE requesting RN to send her manager and email documenting call. EE notified RN will not be sending her manager an email but if manager needs proof of call, to contact EH. EE verbalized back understanding and denied further questions at this time.
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| 34 | 2021-01-14 | fever |
Tachycardia, Tachypnea, achy joints, feeling febrile but no fever, near syncope, anxiety, redness an...
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Tachycardia, Tachypnea, achy joints, feeling febrile but no fever, near syncope, anxiety, redness and hard at injection site 2 days late
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| 34 | 2021-01-14 | fatigue |
Vaccine was received at 4:55pm. 8:30pm, I started to feel fatigued and disoriented. By 9am I started...
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Vaccine was received at 4:55pm. 8:30pm, I started to feel fatigued and disoriented. By 9am I started to feel muscle aches and sharp joint pain, as expected. By 1200 noon, the pain intensity was increasing, coming in waves, lasting 10-15 minutes. The pain waves were 10/10, very severe, and was causing me to shake, cry, and be unable to function or sleep. I was also very disoriented, but I think due to the pain. It was mildly relieved with ibuprofen/Tylenol alternating every 3hrs, but continued until 6pm. It began to subside at 6pm. I am an RN, and sought the advice of my employee health nurse, who advised me to seek medical care if it continued through the night. The pain began to subside, so I did not. However, if a non-healthcare person experiences that, they will think they are dying.
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| 34 | 2021-01-14 | dizziness, headache, fatigue | Very fatigued; Slight headache; Dizziness |
| 34 | 2021-01-14 | malaise, chills |
approximately 3 hours after 2nd dose of vaccine developed body aches, chills, malaise. Next day the...
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approximately 3 hours after 2nd dose of vaccine developed body aches, chills, malaise. Next day these symptoms persisted and also developed nausea/stomach ache and mild tachycardia. Chills, injection site pain, malaise
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| 34 | 2021-01-14 | fever, headache, chills |
fever; chills/Shivering; pelvic pain; nausea; headache; This is a spontaneous report from a contacta...
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fever; chills/Shivering; pelvic pain; nausea; headache; This is a spontaneous report from a contactable consumer. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on the left arm on 06Jan2021 15:15 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history was reported as none. Concomitant medications were not reported. The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (lot/batch number: not provided) via unknown route of administration on the left arm on 20Dec2020 16:15 at a single dose for COVID-19 immunization. On 07Jan2021 04:00, the patient had fever, chills/shivering, pelvic pain, headache, and nausea symptoms resolved next day (08Jan2021). Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events. Information about lot/batch number has been requested.
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| 34 | 2021-01-14 | dizziness |
light headed (airy/helium head feeling); hard to concentrate on more than one task at a time; Flushe...
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light headed (airy/helium head feeling); hard to concentrate on more than one task at a time; Flushed; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular on 22Dec2020 at 11:30 at a single dose on the left arm for COVID-19 immunization in a workplace clinic. Medical history was reported as none. The patient's concomitant medications were not reported. The patient had no known allergies. The patient also did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Dec2020 at 15:00, the patient was light headed (airy/helium head feeling), hard to concentrate on more than one task at a time, and flushed. No treatment was given to the patient. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on an unspecified date. The events were considered non-serious. No follow-up attempts are possible. No further information is expected.
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| 34 | 2021-01-14 | headache, fatigue, cough, throat pain, runny nose |
tunnel vision; experienced a sudden onset of vertigo; presyncope; My hands became cold and numb; My ...
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tunnel vision; experienced a sudden onset of vertigo; presyncope; My hands became cold and numb; My hands became cold and numb; fatigue; sore arm, leg/thigh aching; sniffles; sore throat; brief dry cough; slight headache; neck ache; This is a spontaneous report from a contactable Nurse (patient). A 34-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 05Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included Mild ADHD/ADD. The patient's concomitant medications were not reported. Approximately 5 minutes after receiving vaccination, she was standing in the observation room (where they had all of them stay for at least 15 minutes to ensure no severe reactions) and experienced a sudden onset of vertigo, tunnel vision and pre-syncope. Her hands became cold and numb and she was trying to talk to another staff member who was arranging/scheduling her second vaccination dose at the same time when this event occurred, but it subsided quickly and she started to feel normal again. All these events occurred at 12:45 on 05Jan2021. She reported this event right away and they had her stay in the room longer. She was stable at that point but experienced these symptoms again but very mildly twice more while she walked back to her car to go home. Other side effects on 05Jan2021 that started in the evening and for the following 2-3 days included fatigue, sore arm, leg/thigh aching, sniffles/sore throat, brief dry cough and slight headache/neck ache. Very mild and tolerable symptoms. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. The outcome of all events was resolved in Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 34 | 2021-01-15 | chills, fever, fatigue | Fever (100.4 F), chills, felt very run down/tired. Took Advil. Symptoms resolved after 2 days. |
| 34 | 2021-01-15 | migraine, somnolence |
I received my first dose of the Pfizer COVID vaccine at approximately 9:15am on Thursday, January 14...
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I received my first dose of the Pfizer COVID vaccine at approximately 9:15am on Thursday, January 14, 2021 in my right arm. Almost immediately, I felt a pain go down to my wrist and across my chest. We pulled into the waiting area and around five minutes after the injection the right side of my face went numb., the pain had left my arm and chest by the time. The nurse reacted by calling the emergency room and sending me there.
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| 34 | 2021-01-15 | fatigue, somnolence, weakness | Tiredness, Weakness, Sleepiness. |
| 34 | 2021-01-16 | fever, headache, chills, fatigue |
I woke up around 11:30p (1/15) with aching in my legs. I took some Tylenol a d laid back down. I bec...
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I woke up around 11:30p (1/15) with aching in my legs. I took some Tylenol a d laid back down. I became restless and tossed and turned. My body started aching and by morning (7a 1/16) I had a blinding headaches, body and joint pain and a fever of 101.8. This continued throughout the day 1/16. I also had chills. My fever broke around 2am 1/17 and the body aches went away. I have had a headache and fatigue today (1/17).
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| 34 | 2021-01-16 | fatigue, headache, body temperature increased |
I woke up with pain in my legs, took a bath & some ibuprofen. Laid back down and just tossed and tur...
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I woke up with pain in my legs, took a bath & some ibuprofen. Laid back down and just tossed and turned for a few hours. When it was time to get up with my kids my whole body hurt. I took my temperature and it was 102.4. I took some Tylenol and drank water. I stayed in bed for the day. I ran a fever until late that night. (12/24) When I awoke 12/25 I did not have body aches only a headache and fatigue. By 12/26 I felt better.
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| 34 | 2021-01-16 | headache, chills, body temperature increased |
Received my second vaccine on 1/13/21 at 10:10am. I felt perfectly fine initially, no soreness in my...
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Received my second vaccine on 1/13/21 at 10:10am. I felt perfectly fine initially, no soreness in my arm. By 7 pm my left arm felt sore. By 8 pm I began to have chills, my temp was 98.1 and I had muscle aches. By 10 pm I had a fever of 101.5, chills, muscle weakness, aches, and a headache.
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| 34 | 2021-01-17 | headache |
Vaginal bleeding/spotting/menstruation: on hormonal IUD and don't normally have any sort of period, ...
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Vaginal bleeding/spotting/menstruation: on hormonal IUD and don't normally have any sort of period, but started spotting ~24 hours after 2nd dose of COVID vaccine. Associated with headache and cramping
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| 34 | 2021-01-17 | weakness |
generalized weakness; flushing; my BP is high; dose 1 start date 19Dec2020; dose 2 start date 8Jan20...
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generalized weakness; flushing; my BP is high; dose 1 start date 19Dec2020; dose 2 start date 8Jan2021; This is a spontaneous report from a contactable pharmacist. A 34-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular in left arm on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included chronic HTN and allergies to baclofen and statins. The patient's concomitant medications were unspecified medications taken for hypertension. The patient previously received the first dose of bnt162b2 on 19Dec2020 via intramuscular in left arm, lot EL0140. On 08Jan2021, the patient was brought into ER as code MET. Patient was receiving her second vaccine for COVID-19 when she experienced generalized weakness and flushing. She stated that she knew her BP was high. Endorses hx chronic HTN, reports she took all three medications this AM. The patient denied any headache, new visual change, CP, SOB, or focal weakness. The events recovered on an unknown date in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events.; Sender's Comments: Based on the time association, the events asthenia, flushing and hypertension are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 34 | 2021-01-18 | headache, fatigue |
9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nau...
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9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nausea, vomiting 10th: profound fatigue, hives, intermittent vertigo 11-17th: vertigo, mild headache and neck pain, nausea, vomiting 18th-current: vertigo, nausea, vomiting *Hospitalized from 17-18th, diagnosed with vestibular neuritis secondary to the vaccine
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| 34 | 2021-01-18 | dizziness, fever, headache, weakness, shortness of breath |
Had severe body aches m, fever, headache, progressed into dizziness and "foggy memory", started to h...
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Had severe body aches m, fever, headache, progressed into dizziness and "foggy memory", started to have some chest pain. Felt as if I was intoxicated, lasted the whole day. Woke up the next morning and still felt "out of it" and weak but thought it would get better, went to work (im a nurse). Started having continous vomiting, shortness of breath and chest pain at work. As well as severe tremors. I was taken to the hospital, given fluids and my QT was prolonged with my heart which i have never had before . Was given iv magnesium and waited for my heart rhythm to improve. Was told not to take anymore of my prescribed medications or nausea medications and follow up with my pcp the next day. Im still feeling horrible, nausea, body aches, low grade fever and I am 72 hours out. Now I have huge hospital bill to pay, can't work currently because I still feel bad and my heart has a weird rhythm. Hoping this helps as if this was what I was expecting I would have never got it.
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| 34 | 2021-01-18 | chills, fever | Woke up feeling achy, chills, Feverish Low grade fever Estimated date of delivery 08/25/2021 |
| 34 | 2021-01-19 | fever, fatigue, dizziness |
After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After...
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After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; After 2nd dose myalgia body ache fever axillary lymph node swelling and pain dizziness nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient to received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 and expiration date not provided), via an unspecified route of administration (right arm) second dose on 08Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medication included vitamin c [ascorbic acid]. The patient previously took Benzoyl peroxide and experienced allergies and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 and expiration date not provided) intramuscular (right arm) first dose on 18Dec2020 for Covid-19 immunization and experienced flu like symptoms for 48 hours plus bilateral cheek numbness for two weeks. On 08Jan2021, after the second dose the patient experienced myalgia body ache fever axillary lymph node swelling and pain dizziness nausea. This was day 4 post vaccine, still have severe dizziness and fatigue. On 04Jan2021, the patient underwent lab tests and procedure which includes Coronavir Pan 2019-NCOV, NAA with the result of Negative and Nasal Swab with the result of Negative. The patient did not receive any treatment for the events. The outcome of the events was not recovered. Facility where the most recent COVID-19 vaccine was administered in the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination.
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| 34 | 2021-01-19 | skin warm | Delayed redness, swelling, hot to touch 48+ hours after injection |
| 34 | 2021-01-19 | chills, fatigue |
Fatigue, chills lasting from 2 hours post- vaccine through the end of the night, vaccine was at 8am,...
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Fatigue, chills lasting from 2 hours post- vaccine through the end of the night, vaccine was at 8am, onset of symptoms at 10am lasting until bedtime.
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| 34 | 2021-01-19 | fever, chills, dizziness, headache |
Fever of 103 C, chills, body ache, severe headache, nausea, metallic taste in the mouth 2nd dose of ...
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Fever of 103 C, chills, body ache, severe headache, nausea, metallic taste in the mouth 2nd dose of vaccination given at 11 am 1/14/2021. Pain at the injection site . Then body ache started. Midnight 1/14/2021 - chills started, fever 103, severe headache- Fever, body ache and headache continued till Monday(1/18/2021) Strong Metallic taste in the mouth, nausea, dizziness- still continuing.
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| 34 | 2021-01-19 | weakness, headache | HEADACHE, BODYACHES, WEAK |
| 34 | 2021-01-19 | headache | Headache with nausea and vomiting Injection site pain |
| 34 | 2021-01-19 | fever, headache |
High fever, muscle pain, joint pain, headache, chills, swollen Lymph nodes in the arm of injection (...
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High fever, muscle pain, joint pain, headache, chills, swollen Lymph nodes in the arm of injection (armpit)
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| 34 | 2021-01-19 | fatigue, fever, chills |
I experienced extreme body aches that were so bad I was unable to perform daily tasks. I also had fe...
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I experienced extreme body aches that were so bad I was unable to perform daily tasks. I also had fever, chills and fatigue as well as nausea.
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| 34 | 2021-01-19 | sweating, fatigue |
I had one day of sweats, body aches, and fatigue in which I stayed in bed the calendar day after I g...
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I had one day of sweats, body aches, and fatigue in which I stayed in bed the calendar day after I got the second vaccine. I planned to get the vaccine on a Friday when I was off the following day in case this happened so I could rest, but if I had been scheduled to work I would have taken the day off to rest based on the symptoms. I felt normal the next calendar day. I was 31 weeks pregnant at the time, had no adverse events related to the pregnancy, and am due 3/10/21 with a delivery scheduled 3/3/21; baby and mom are doing just fine.
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| 34 | 2021-01-19 | throat pain, fatigue |
Patient presented to urgent care on 1/17/2021 after receiving second dose of Pfizer COVID-19 vaccine...
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Patient presented to urgent care on 1/17/2021 after receiving second dose of Pfizer COVID-19 vaccine on 1/14/2021. Patient stated that she had a sore throat and was fatigued X 3 days. Patient endorsed body aches and nausea immediately after vaccination. Patient had expiratory wheezing in left upper lung and has a history of asthma. Patient endorsed increased inhaler use over the past few days. Patient was given outpatient rx for prednisone and viscous lidocaine.
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| 34 | 2021-01-19 | chills, throat pain, fever, fatigue | Severe chills that last hours, fever of 101.1, full body aches, sore throat, exhaustion. |
| 34 | 2021-01-19 | fatigue, chills, headache, fever |
Starting the morning after my vaccine, at 0930, I had a headache and began to feel tired. I took tyl...
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Starting the morning after my vaccine, at 0930, I had a headache and began to feel tired. I took tylenol and a nap. Around 1100-1130, I started to feel a little feverish, but did not have a fever. Around 1200, I began to have chills, my headache returned, and my fingers and toes felt frozen/numb. I took a very hot bath for approximately 45 minutes and subsequently laid in the bed (with intermittent napping) for 2 hours. Upon full wake up around 1430, I had no more chills, no headache, and felt back to my normal self.
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| 34 | 2021-01-19 | fever, fatigue, dizziness, cold sweat |
Sudden onset severe muscle aches; Joint pain; Nausea; Lightheaded; Fever; Cold sweats; Fatigue; This...
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Sudden onset severe muscle aches; Joint pain; Nausea; Lightheaded; Fever; Cold sweats; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 18Dec2020 08:15 AM as a single dose for COVID-19 immunization, lot number: EL0140. Medical history was reported as none. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications in two weeks prior to the vaccination included Multivitamins, Vitamin C, Vitamin D3, zinc oxide and fluticasone propionate (FLONASE). On 18Dec2020 04:00 PM patient experienced sudden onset severe muscle aches, joint pain, nausea, lightheaded, fever, cold sweats and fatigue. No treatment was received for the events. Patient recovered from all the events on unknown date in Jan2021. Patient had not been tested for COVID-19 post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015086 same patient/vaccine, different dose/event
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| 34 | 2021-01-19 | throat irritation |
Tight and itchy throat, thick tongue- started approximately 5 minutes after vaccine administration a...
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Tight and itchy throat, thick tongue- started approximately 5 minutes after vaccine administration and lasted for approximately 4 hours.
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| 34 | 2021-01-19 | fatigue, headache |
Very sore arm at injection site, headache all day, feeling tired, muscle aches. All of these symptom...
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Very sore arm at injection site, headache all day, feeling tired, muscle aches. All of these symptoms lasted for about 12 hours and started about 18 hours after I receiving the vaccine.
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| 34 | 2021-01-19 | fever, chills | fever, chills, aches |
| 34 | 2021-01-19 | headache | hand swelling headache body pain general GI upset |
| 34 | 2021-01-19 | malaise, headache |
~ 6 hrs after vaccination, headache started ~18 hrs after vaccination, still had headache and also f...
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~ 6 hrs after vaccination, headache started ~18 hrs after vaccination, still had headache and also felt malaise ~24 hrs after vaccination, still had headache and malaise, and started feeling total body aches/soreness ~36 hrs after vaccination, all other symptoms resolved but now had swollen and tender lymph node under R arm. Approaching 48 hrs from vaccination and the swollen lymph node has not resolved. Of note - I am currently breastfeeding. I did not have any decrease in my breastmilk supply and noted no changes in my infant either.
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| 34 | 2021-01-20 | fatigue, headache, fever |
Fever; muscle aches; joint pain; tiredness; headache; BNT162B2 first dose on 21Dec2020 and second do...
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Fever; muscle aches; joint pain; tiredness; headache; BNT162B2 first dose on 21Dec2020 and second dose on 09Jan2021, spaced less than 3 weeks; This is a spontaneous report from a contactable nurse (patient self). A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), via an unspecified route of administration on 09Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD). Patient had no known allergies. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot: EL0140) on 21Dec2020 12:00 pm left arm for COVID-19 immunisation. Patient experienced fever, muscle aches, joint pain, tiredness, headache on 10Jan2021 02:00 am with outcome recovering. No treatment was received for the events.
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| 34 | 2021-01-20 | fever |
I am a resident physician/ employee at the Hospital. I developed acute perforated appendicitis 56 ho...
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I am a resident physician/ employee at the Hospital. I developed acute perforated appendicitis 56 hours after receiving the 2nd dose of Pfizer COVID vaccine. I received the vaccine on 1/12/21 and developed symptoms of epigastric pain and vomiting on 1/14/21. On 1/15/21, I developed fever and right lower quadrant pain that was sustained. I presented to the Hospital Emergency Department on 1/17/21 and was diagnosed with acute perforated appendicitis by CT with contrast. I underwent emergency appendectomy at The Hospital on 1/17/21 and was hospitalized from 1/17/21-1/19/21.
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| 34 | 2021-01-21 | fatigue, fever, headache |
*Vomiting and diarrhea by 4:30pm *Headache by 6:30 *Fever of 101.3 by 10:00 continued until 4:00am o...
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*Vomiting and diarrhea by 4:30pm *Headache by 6:30 *Fever of 101.3 by 10:00 continued until 4:00am on January 22 *Extreme fatigue for 24 hours *muscle pain and weakness for 24 hours
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| 34 | 2021-01-21 | fever, headache, dizziness, chills |
? Chills (from 12 hours after the shot until present?33 hours so far) ? Slight fever (under 100) ? H...
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? Chills (from 12 hours after the shot until present?33 hours so far) ? Slight fever (under 100) ? Headache ? Nausea & vomiting ? Dizziness ? Insomnia
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| 34 | 2021-01-21 | dizziness |
About 10 minutes after injection the patient was feeling faint, racing heartbeat and was instructed ...
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About 10 minutes after injection the patient was feeling faint, racing heartbeat and was instructed to sit down. Never lost consciousness and was able to able to breath through the event and drink water after a couple of minutes. Patient also felt rapidly hot and dizzy. We had her sit down, take deep breaths, kept her talking, offered water, and got epinephrine ready. She recovered completely after a total of 30 minutes but did feel slightly dizzy throughout the day. Was able to continue with regular workday as we determined it was best she stayed with other people for the remainder of the day.
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| 34 | 2021-01-21 | weakness, dizziness |
Felt like a electric shock at the moment of vaccination. On the next day, extreme weakness, severe b...
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Felt like a electric shock at the moment of vaccination. On the next day, extreme weakness, severe body pain, and dizziness. Felt like she was going to pass out in the bathroom so she called her husband to assist her. Stayed 1 day in bed. Didn't received treatment.
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| 34 | 2021-01-21 | fever, chills, headache, sweating | Fever, Sweats, Chills, Headache, Nausea |
| 34 | 2021-01-21 | fatigue, fever, headache | Fever, muscle/body aches, headache, fatigue |
| 34 | 2021-01-21 | headache, fever, headache, fever | Headache Fever |
| 34 | 2021-01-21 | dizziness |
Immediately afterwards developed L-sided facial weakness/numbness, stiff neck, BUE/BLE paresthesia, ...
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Immediately afterwards developed L-sided facial weakness/numbness, stiff neck, BUE/BLE paresthesia, sensation of feeling hot (T 99 F). Was observed for 2 hours, given Benadryl. No longer feeling paresthesia or hot, but still has mild L-sided facial weakness, stiff neck, and in past 2-3 days having dizziness upon awakening, resolves after a few minutes. No dysphagia. Never had facial droop. BP 119/80. Spoke w/physician 2 days ago about her symptoms and was reassured they're due to vaccine.
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| 34 | 2021-01-21 | headache, skin warm, fatigue, body temperature increased |
On Tuesday, 11/19 about 10 pm, I started feeling some discomfort in my left breast. The next mornin...
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On Tuesday, 11/19 about 10 pm, I started feeling some discomfort in my left breast. The next morning, I was fatigued, had a headache, and woke up with an elevated basal body temperature (I'm normally between 96.0 and 97.5 in the mornings, but ran at 98.2. Not a fever, but enough for me to think it was odd), and some discomfort in my left breast. By the afternoon, part of my breast was red and warm to the touch. My temperature was still in the normal range at 98.7 (I checked since I work in a hospital and wanted to make sure I reported any illness quickly). I went to the ambulatory care center and was diagnosed with mastitis of the left breast and prescribed cephalexin 500 mg capsule QID x10. After 7 doses, I am feeling better and the tenderness, discoloration, and warmth are gone.
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| 34 | 2021-01-21 | dizziness, chills, sweating, nasopharyngitis, fatigue |
The day of my 1st vaccine, about 10 min after I was in the waiting room and I started feeling "weird...
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The day of my 1st vaccine, about 10 min after I was in the waiting room and I started feeling "weird" in my whole body and lightheaded. I got some juice. Then I started to get hot and was sweating, my whole face and neck were flushed; I also felt mild burning sensation on the R lower lung area. They took me in back and gave me more juice and water and put ice packs on me. It took 30+ minutes to feel better. They called a team to come do my vitals and my HR was in the 100s and they said my eyes were dilated. On my way home I had a weird throbbing pain in my L upper chest just above my boob. When I got home I had chills/felt freezing for a few hours and was fatigued. The next day (Sun) I had moderate joint pain, fatigue, and was very achy; my chest felt tight and I needed my inhaler and some tramadol. On Mon I felt better and went back to work, but then Tues I was achy again and my coworker said I looked pale; I took some tramadol and felt better, just tired. On wed I was having pains in my neck, shoulder, down my arm L arm, and down my scapula- the arm I had the injection. Throughout the day the pain was throbbing and ended up a 7/10 and edema in my neck/shoulder/axillary occurred; I couldnt carry anything heavy and was guarding that arm. Tramadol didn't help the pain and I eventually took 600mg ibuprofen and made a telemedicine visit w/ my MD for the next day. After 3 days the pain was subsiding but the edema took ~ 1 week- it subsided the weekend before my next vaccine. The day of my 2nd dose I did ok after the vaccine at 4pm. While they were injecting it I felt burning down my arm. I felt lightheaded and "weird" afterwards and warm, but no eye dilation or flushing. 3 hours after the vaccine at 7pm I felt tired and a little achy and slept from 7-9pm. At 9pm I woke up very achy, I had 1 itchy hive that popped up on my R inner forearm. The next day I had joint pain in every joint and very achy and fatigued. The joint pain subsided on day 2 after the vaccine but I was very achy and fatigued for a good 72 hrs. Vaccine was wed and saturday the pain in my neck returned and the edema came back and was a little worse than before, and the area where the edema was, was painful to touch. It started subsiding ~ a week after the vaccine, but a little bit is still currently here- but no pain to touch. My allergist has been following up w/ me this whole time.
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| 34 | 2021-01-21 | throat irritation |
pt reported scratchy throat starting at 10:40. pt reported to us at 10:50. Pt was given #2 Benadryl ...
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pt reported scratchy throat starting at 10:40. pt reported to us at 10:50. Pt was given #2 Benadryl and reported feeling better at 11:46. pt returned to work at that point.
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| 34 | 2021-01-24 | fatigue |
Diarrhea- started around 1am, on and off for 12 hours. Fatigue-from 9am-10pm Muscle soreness-at v...
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Diarrhea- started around 1am, on and off for 12 hours. Fatigue-from 9am-10pm Muscle soreness-at vaccintion site on left arm, both shoulders, upper back, neck. Lasted all day while awake.
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| 34 | 2021-01-24 | body temperature increased |
Fever spike to 102, muscle pain at injection site and all over left side of the body. The fever star...
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Fever spike to 102, muscle pain at injection site and all over left side of the body. The fever started at night on 1/21/21 and spiked over 100 around 7am the next day (1/22/21). The fever broke around 5 pm on 1/22/21 after taking Tylenol (2 tablets every 6 hours started around 9am on 1/22). My temperature dropped to 98.9 around 5pm on 1/22; Continued drinking fluids and took another dose of Tylenol before bed at 12:30am. Woke up with no fever the next day (1/23) however muscle pain on the left side of the body is still present.
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| 34 | 2021-01-24 | fatigue, chills |
I got my vaccine around noon on 1/23 and woke up 1/24 with chills, body aches, and was fatigued. I t...
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I got my vaccine around noon on 1/23 and woke up 1/24 with chills, body aches, and was fatigued. I took ibuprofen- 2 separate doses that day- which helped. I felt that all these symptoms had completely resolved by about 7pm on 1/24.
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| 34 | 2021-01-24 | chills | muscle aches, back pains, and chills |
| 34 | 2021-01-25 | chills | Body aches, joint pain, chills without fever, headache, nausea, fatigue |
| 34 | 2021-01-25 | fever, headache | HA, fever = 101, body aches. |
| 34 | 2021-01-25 | dizziness, fever, nasal congestion, headache, fatigue, chills |
Headache; nausea; congestion; muscle aches; extreme joint pain; fatigue; dizziness; neck pain; fever...
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Headache; nausea; congestion; muscle aches; extreme joint pain; fatigue; dizziness; neck pain; fever; chills; tachycardia; This is a spontaneous report from a contactable other health professional reporting for herself. A 34-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL3246, expiry date: not reported), intramuscular, on 09Jan2021 10:30 AM, at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included gastrooesophageal reflux disease (GERD). She had no allergies to medications, food, or other products. Concomitant medications included esomeprazole sodium (NEXIUM). The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EJ1685, expiry date: not reported), intramuscular, on 19Dec2020 12:00 PM, at a single dose on right arm for COVID-19 immunization. On 09Jan2021 11:00 AM, the patient experienced headache, nausea, congestion, muscle aches, extreme joint pain, fatigue, dizziness, neck pain, fever, chills and tachycardia. The adverse events resulted to Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19; she had undergone Nasal Swab, test name: COVID-19 nasopharyngeal swab, on 11Jan2021 with result of negative. The patient received metoprolol as corrective treatment for the reported adverse events. Outcome of the events was recovering.
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| 34 | 2021-01-25 | fatigue, dizziness, weakness |
I experienced weakness, fatigue, lightheadedness for the most of day after receiving the shot. Sympt...
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I experienced weakness, fatigue, lightheadedness for the most of day after receiving the shot. Symptoms reduced with rest, plenty of water. Symptoms resolved by morning of 1.26.2021
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| 34 | 2021-01-25 | fatigue, headache |
Injection site red; Tennis ball sized hard lump; Injection site pain; Injection site Swollen; Facial...
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Injection site red; Tennis ball sized hard lump; Injection site pain; Injection site Swollen; Facial pain; Fatigue; Headache; This is a spontaneous report from a contactable other Health Professional (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1284), intramuscularly in left arm on 10Jan2021 08:00 at single dose for COVID-19 immunization. The patient medical history was not reported. Known allergies: No. Other medical history: No. The patient was not pregnant. The patient's concomitant medications were not reported. If other vaccine in four weeks: No. Other medications in two weeks: No. Facility type vaccine: Hospital. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899) on 20Dec2020 for COVID-19 immunization. The patient experienced injection site pain, swollen, red, tennis ball sized hard lump, fatigue, headache, facial pain, all on 11Jan2021 06:00 with outcome of recovering. No treatment received for all the events. If COVID prior vaccination: No. If COVID tested post vaccination: No.
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| 34 | 2021-01-25 | headache |
Right arm pain and injection site x 3 days, headache, right side body aches x 3 days. Kidney pain x ...
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Right arm pain and injection site x 3 days, headache, right side body aches x 3 days. Kidney pain x 2 days.
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| 34 | 2021-01-25 | fatigue |
This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient (no...
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This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) via an unspecified route of administration on 07Jan2021 10:00 AM at a single dose in the right arm for COVID vaccine. Medical history included high blood pressure. She has no known allergies. Concomitant medications included hydrochlorothiazide (HCTZ), guaifenesin/ paracetamol/ phenylephrine hydrochloride (TYLENOL SINUS), multivitamin, and Almopid (other medications in two weeks). The patient had no other vaccine in four weeks. The patient experienced extremely tired on 12Jan2021 06:00 AM. Treatment was not received for the event. She had no COVID prior to vaccination. She was not COVID tested post vaccination. The outcome of the event was recovering.
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| 34 | 2021-01-25 | discomfort |
This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 21Dec2020 15:30 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergies. On 23Dec2020 13:00, patient discovered a lump on the bottom of her left armpit, felt a lot of discomfort when touching it. It went away around 02Jan2021. Patient does not have COVID prior vaccination. COVID was tested post vaccination via nasal swab, COVID test date on 07Jan2021, and COVID test result was negative. No treatment was received for the events. The events recovered on 02Jan2021. Information on the lot/batch number has been requested.
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| 34 | 2021-01-25 | head discomfort, chills, malaise |
Woke up morning of Monday, January 25,2021 at 230am for work and felt nauseous, had chills and body ...
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Woke up morning of Monday, January 25,2021 at 230am for work and felt nauseous, had chills and body aches and hurt to the touch all over. My head felt heavy. I had to leave work early and took off the next day due to not feeling well
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| 34 | 2021-01-25 | chills |
muscle pain all over my body; chills; feel the lump in the same area/left armpit; This is a spontane...
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muscle pain all over my body; chills; feel the lump in the same area/left armpit; This is a spontaneous report from a contactable consumer. A 34-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 11Jan2021 13:00 (1PM) at a single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient had no Covid prior to vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergies. The patient had first dose of bnt162b2 for covid-19 immunization on 21Dec2020, 03:30 PM, in the left arm (number and expiry date not reported) and after the administration of the vaccine, patient discovered a lump on the bottom of the left armpit; felt a lot of discomfort when touching it and it went away around 02Jan2021. Post vaccination, patient was tested for Covid as nasal swab on 07Jan2021 with result as negative. When the second vaccine was administered, patient felt muscle pain all over her body, chills and started to feel the lump in the same area (left armpit) the day after the vaccine was administered (12Jan2021). No treatments received in response to the events reported. The patient did not recover from the events muscle pain all over her body, chills, and lump in the same area (left armpit). Information on Lot/Batch number has been requested.
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| 34 | 2021-01-26 | somnolence, fatigue, headache, runny nose |
25 Jan evening-fatigue, sleepy, injection site red, HA, runny nose 26th Jan 2021-more fatigued, low ...
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25 Jan evening-fatigue, sleepy, injection site red, HA, runny nose 26th Jan 2021-more fatigued, low back, hips, legs achy, runny nose, HA 27th January-SAME-nose stopped running, increased fatigue, site of injection-more red/swollen, rt armpit-achy & swollen Treatment-she said she took an aleve this AM-27th Jan, and she will get some PEDILYTE today to sip
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| 34 | 2021-01-26 | fatigue, headache, cough |
Diarrhea, Nausea, Headache, Fatigue, Body Aches started at 4am Tuesday 1/26 and still ongoing today ...
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Diarrhea, Nausea, Headache, Fatigue, Body Aches started at 4am Tuesday 1/26 and still ongoing today presently. Cough is starting today.
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| 34 | 2021-01-26 | chills, fever, fatigue |
Patient with underlying MS and pregnancy. Patient reported that Fever, body aches, chills, fatigue ...
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Patient with underlying MS and pregnancy. Patient reported that Fever, body aches, chills, fatigue after administration of 2nd dose. Presented to the Emergency Department / OB triage in labor 4 days later (1.24.21) Patient is a 34 y.o. female at 37w0d with Estimated Date of Delivery: 2/14/21 who presents today with spontaneous labor. HOSPITAL COURSE: Patient underwent an uncomplicated vaginal delivery and was discharged home in stable condition. ESTIMATED DUE DATE: Estimated Date of Delivery: 2/14/21 GESTATIONAL AGE AT DELIVERY: 37w0d. Patient weight = 2.63 KG
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| 34 | 2021-01-27 | fever, chills, headache |
Fever 102; chills; headache; back pain; lymphadenopathy in cervical, axilla, and groin; This is a sp...
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Fever 102; chills; headache; back pain; lymphadenopathy in cervical, axilla, and groin; This is a spontaneous report from a contactable other healthcare professional (hcp, reported for herself). A 34-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 12Jan2021 15:30 at a single dose in the left arm for COVID-19 immunization. Medical history included allergies to penicillin. The patient was not pregnant at the time of the report. The patient had no covid prior to vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had first dose of COVID-19 vaccine bnt162b2 on 23Dec2020 08:30 AM in the left arm (at the age of 34 years old). On 13Jan2021 12:00 PM, patient experienced fever 102, chills, headache, back pain, and lymphadenopathy in cervical, axilla, and groin. No treatments received in response to the events reported. The patient was not COVID tested post vaccination. The outcome of the events fever 102, chills, headache, back pain, and lymphadenopathy in cervical, axilla, and groin was recovering. Information on batch/lot number was requested.
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| 34 | 2021-01-27 | chills, fever, shortness of breath | High fever. Aches chills. Sob. 4 days. Passed on 1/27/2021 |
| 34 | 2021-01-27 | fatigue, dizziness, headache |
On the day of the vaccination in the afternoon I felt very tired and at times I felt dizzy. The nex...
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On the day of the vaccination in the afternoon I felt very tired and at times I felt dizzy. The next day I woke up with an intermittent headache, little bit fatigue, very very tired, my arm was super heavy and I was in bed all day. The third day I felt dizzy at times, tired, my eyes itched a lot and my body. I didn't take any medication at any time.
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| 34 | 2021-01-28 | fever, weakness, fatigue |
1/9/21 woke up with fever, body aches and fatigue. 1/10/21 developed right lower back pain radiating...
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1/9/21 woke up with fever, body aches and fatigue. 1/10/21 developed right lower back pain radiating to right side and right lower quadrant without any known injury. Presented to ER on 1/11/21 and was found to have elevated liver enzymes. 1/12/21 woke up with right thigh numbness and was referred to spine specialist by PCP. Saw spine specialist on 1/14/21 and was referred to physical therapy and given medrol dose pack taper. Repeated liver enzymes after 1 week resulted with abnormal results and referred to GI doctor. 1/28/21 Developed worsening right thigh numbness with decreased strength to right leg and following up with spine specialist on 02/01/21.
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| 34 | 2021-01-28 | headache, chills, fatigue |
12 hours post vaccination had chills and body aches, restless sleep. The morning after whioe body so...
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12 hours post vaccination had chills and body aches, restless sleep. The morning after whioe body soreness, tired, nauseous, pain at injection site, headache. Took 1000 mg Tylenol at 11 am and 7 pm. Day 2 Body aches, tired. Currently 12 weeks pregnant as of 2nd dose date.
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| 34 | 2021-01-28 | cough, fatigue, shortness of breath |
12/24 she lost her voice, developed a cough and SOB, developed rash and bruising. She had fatigue...
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12/24 she lost her voice, developed a cough and SOB, developed rash and bruising. She had fatigue, muscle and joint pain. 12/26 She developed generalized petechiae.
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| 34 | 2021-01-28 | shortness of breath, chills, fatigue |
Evening of 1/25/2021 she experienced a sore arm and toss and turned through out hours of sleep. Repo...
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Evening of 1/25/2021 she experienced a sore arm and toss and turned through out hours of sleep. Reports significant s/sx onset this morning arounf 0100, 1/26/2021 to include chest tightness with a sharp pain when inhaling, all over body aches, chills, fatigue and sore arm. Employee states about 1 hr. post vaccination she tasted blood in her mouth and noticed when she . States supervisor referred to OH to be evaluated. Employee also reports hx. of COVID illness with a positive result on 12/27/2021. States onset of s/sx was on 12/26/2021. Patient reported to employee health clinic to report adverse event. On, 1/27/2021 patient was seen by her PCP for evaluation.
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| 34 | 2021-01-28 | fatigue | Fatigue, arm pain, contractions (baby due date 7/30/2021) |
| 34 | 2021-01-28 | body temperature increased, headache, chills |
Fever up to 104, body aches, chills, headaches Tylenol and Motrin alternated every 5 hours Symptoms ...
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Fever up to 104, body aches, chills, headaches Tylenol and Motrin alternated every 5 hours Symptoms started on Wednesday 1/27/21 @ 2am and finished on Thursday morning 1/29/2021
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| 34 | 2021-01-28 | migraine, fatigue |
Injection site got sore after just a few moments. Site itched. Began experiencing extreme fatigue. W...
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Injection site got sore after just a few moments. Site itched. Began experiencing extreme fatigue. Within the first 15 hours following the injection I began experiencing extreme full body pain, neck, back, arms, legs, hands, and fingers. As well as experiencing a major headache equivalent to migraine pain. The pain was intense and lasted around 36 hours. Pain had subsided within 48 hours excluding pain at injection site that continued but was significantly milder.
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| 34 | 2021-01-28 | headache | Persistent headache lasting 3 days, no improvement with acetaminophen. |
| 34 | 2021-01-28 | body temperature increased, headache, chills, fever |
Received my second dose of Covid vaccine 1/26/21 at 1320. No immediate adverse reaction occurred. I ...
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Received my second dose of Covid vaccine 1/26/21 at 1320. No immediate adverse reaction occurred. I started experiencing injection arm soreness around 2100. By midnight I was experiencing chills and body aches. The morning of 1/27 my Temp was 100.0 and I was still having body aches and chills/feeling feverish. This continued throughout the day. I took one dose of Tylenol 1g and later ibuprofen 600mg. The morning of 1/28 I still had a mild headache and temp of 100.00 but overall was feeling much better - no more chills or body aches. My temp prior to going to work that night was 98.6 and my headache had resolved.
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| 34 | 2021-01-28 | fatigue, fever |
Stiff, sore arm immediately lasting at least 48 hours. Hard and bruised at injection site. Developed...
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Stiff, sore arm immediately lasting at least 48 hours. Hard and bruised at injection site. Developed low grade temp, flushed face, fatigue, muscle stiffness, body aches hours following vaccine. Aches and fatigue continues and it?s now day 8. The fatigue is constant but comes in waves. I?m taking unexpected naps which are abnormal for me. Caffeine and methylphenidate are ineffective. I?m still sore. I also have brain fog, maybe from the fatigue. I can?t think straight and it takes me longer to process and do tasks. I woke up 2 hours ago and I can?t wait to sleep again.
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| 34 | 2021-01-28 | dizziness |
light headed; Tingling of body and face; rash on right arm; This is a spontaneous report from a cont...
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light headed; Tingling of body and face; rash on right arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: El0142), via an unspecified route of administration at site of left arm on an unspecified date at single dose for COVID-19 immunization. Medical history included COVID-19 (COVID-19 antibody test with positive result) and allergies; Iodine. Concomitant medication included vitamin c [ascorbic acid] and calcium. Both received within two weeks if vaccination. The patient experienced lightheaded, tingling of body and face and rash on right arm on 17Jan2021. Facility type vaccine was in hospital. No other vaccine received in four weeks. No treatment received for adverse event. No covid tested post vaccination. The outcome of events was recovering.
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| 34 | 2021-01-31 | headache, fever, fatigue |
I became very tired almost immediately after my second dose, and proceeded to take a 3 hour nap. Upo...
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I became very tired almost immediately after my second dose, and proceeded to take a 3 hour nap. Upon waking up from the nap, I had full body aches, joint pain, a headache, and a low grade fever. Said symptoms have now lasted over 24- hours
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| 34 | 2021-02-07 | skin warm, throat irritation |
swelling; hot to touch; started lightly at injection site but rash more prominent on sides and back ...
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swelling; hot to touch; started lightly at injection site but rash more prominent on sides and back of neck; started lightly at injection site but rash more prominent on sides and back of neck; scratch throat; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown due to not available/provided to reporter at the time of report completion), via an unspecified route of administration in left arm on 20Jan2021 13:30 at single dose for COVID-19 immunization. The patient's medical history included mild hashimotos (no meds, just monitor) and Polycystic ovarian syndrome (PCOS). No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. It was reported that "48 hours" post injection patient developed neck rash, swelling, hot to touch, started lightly at injection site but rash more prominent on sides and back of neck, and scratch throat. All the events resulted in: emergency room/department or urgent care visit. Therapeutic measures were taken as a result of all the events: Steroid and Benadryl injection. The outcome of the events was recovered with lasting effects. The events was considered as non-serious by reporter, as no resulting in death, no life threatening, no causing/prolonging hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.?; Sender's Comments: Causality cannot be excluded for PFIZER-BIONTECH COVID-19 VACCINE and the reported events.
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| 34 | 2021-02-10 | fever, body temperature increased, headache, discomfort, chills |
Fever; Headache; Chills; Feeling like a heavy weight on her body; Back pain; This is a spontaneous r...
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Fever; Headache; Chills; Feeling like a heavy weight on her body; Back pain; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EZ3247), via an unspecified route of administration in the left arm on 23Jan2021 at 15:20 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included gestational diabetes (first pregnancy) from an unknown date to an unknown date and two pregnancies on unknown dates. Concomitant medications included unspecified post-natal multivitamins and paracetamol (TYLENOL; Lot Number: SBA22; Expiration Date: Jan2023) taken before getting the vaccine on 23Jan2021 to prevent soreness. The patient previously received the first dose of BNT162B2 on 03Jan2021 (at the age of 34-years-old; Lot Number: EL0142) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination (except the first dose). On 24Jan2021 at 04:00, the patient experienced chills and had a feeling like a heavy weight on her body. On 24Jan2021 at 07:00, the patient had a fever and headache. On 24Jan2021, she also had back pain. The clinical course was as follows: On 23Jan2021, the patient took paracetamol before getting the vaccine as she heard one can feel sore after getting it. The patient received the second dose on 23Jan2021 at 15:20. The patient was okay after she got the vaccine. However, early the next morning (24Jan2021), she had shivering without any fever (later referred to as chills). The chills were something she never experienced in her life. It was like she was in the cold. She could not move, it was that bad. She felt a heavy weight on her whole body. She could not get out of bed. A few hours later at 07:00, she checked her temperature and it was 102.5 degrees Fahrenheit. She took paracetamol. The headache started with the fever around 07:00. She stated she kept taking paracetamol. She did try to stop using paracetamol, but without it, the headache was still there. The back pain was also severe on 25Jan2021. The chills recovered on 25Jan2021 and the fever was recovered on 26Jan2021. The clinical outcomes of the headache and felt like a heavy weight on the body were unknown; while that of the back pain was not recovered. The events of chills, fever, headache, and back pain were reported as serious by the patient (nurse) for being medically significant. The patient (nurse) assessed the events of chills, fever, headache, back pain, and felt like a heavy weight on her body were related to the vaccine.; Sender's Comments: Based on a compatible temporal association and known BNT162B2 vaccine safety profile causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 34 | 2021-02-10 | headache, migraine |
right sided facial paralysis; headache/migraine from base of R skull radiating to R Ear and top of h...
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right sided facial paralysis; headache/migraine from base of R skull radiating to R Ear and top of head; This is a spontaneous report from a contactable nurse. This 34-Year-Old female nurse (patient) received 2nd dose of BNT162B2 (lot number=EL3247) Intramuscular on 21Jan2021 00: 00 AM (reported as 20Jan2021 12:00 PM) on Right arm for covid-19 immunization. Medical history and concomitant drug were not reported. Past drug was Known allergies to doxycycline. Historical Vaccine was 1st dose of BNT162B2 (lot number=EL1284, on 31Dec2020, 12:15 PM, administrator route=Intramuscular, vaccine location=Right arm). No other vaccine in four weeks. Patient received vaccine on Wednesday 20Jan2021, went to ER on Sunday 24Jan2021 with right sided facial paralysis and headache/migraine from base of R skull radiating to R Ear and top of head from 23Jan2021 10:00 AM with outcome was Recovering. Treatment was medications prednisone and antiviral. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of facial paralysis due to temporal relationship and current drug safety profile. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 34 | 2021-02-16 | dizziness, shortness of breath |
shortness of breath; throat tightening; Increased HR over 120 bpm; dizziness; This is a spontaneous ...
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shortness of breath; throat tightening; Increased HR over 120 bpm; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 29Jan2021 14:30 in left arm, at single dose for covid-19 immunization. Medical history included known allergies: sulfa, and peanuts. Concomitant medication included prednisone. The patient previously took iodine and experienced allergy, and previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 08Jan2021 15:30 in left arm, at single dose for covid-19 immunization and experienced facial swelling within a couple hours of the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the 2nd dose within 30 minutes, 29Jan2021 15:00, the patient had Increased HR over 120 bpm, shortness of breath, dizziness and throat tightening, which all caused hospitalized and Emergency room. Epinephrine injection, fluid, and rest was received as treatment. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Amendment: This follow-up report is being submitted to amend previous reported information: historical vaccine information was added.; Sender's Comments: Based on the compatible time association, the events shortness of breath, dizziness ,throat tightening and heart rate increased are possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 34 | 2021-02-21 | throat swelling |
Developed swelling to face, gums, throat-unable to swallow. Denies SOB. Went to urgent care treated ...
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Developed swelling to face, gums, throat-unable to swallow. Denies SOB. Went to urgent care treated to Solumendrol and Solumedrol dose pack. Resolved after 3-4 weeks. Now at baseline.
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| 34 | 2021-02-21 | fever, headache, fatigue |
The next day on 1/15/2021 around noon I felt achy, fatigue, muscle aches, headaches, & feverish. The...
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The next day on 1/15/2021 around noon I felt achy, fatigue, muscle aches, headaches, & feverish. They went from mild to sever as the day continued. This symptoms stayed severed for the next 12hrs then they went mild for the next 3 days.
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| 34 | 2021-02-21 | headache, chills |
Vaccination was at 9:17am. Injection site arm pain and stiffness was noticeable by 12pm, and gradual...
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Vaccination was at 9:17am. Injection site arm pain and stiffness was noticeable by 12pm, and gradually worsened to incredibly painful by 8 pm, especially in muscles between left shoulder blade and spine. Chills began around 9:30pm at which point I took one 500mg Tylenol and went to sleep. I woke up with severe chills around 1:45 am and pushed off taking more 500mg Tylenol until 2:45 am. Afterwards I began to feel heartburn and slight nausea but was able to fall back to sleep. I woke up around 3:45 am to vomit. Afterwards, the nausea subsided and I was able to go back to sleep until 6:45am. I woke up with a headache which got worse and I took one Aleve at 9 am. By late afternoon I was feeling much better.
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| 34 | 2021-02-22 | dizziness, shortness of breath | Began feeling short of breath and dizzy. Was given 25mg Benadryl PO and symptoms resolved |
| 34 | 2021-02-22 | fatigue, dizziness, night sweats |
Extreme fatigue, burning muscles, bruising, night sweats, borderline low platelets, high MPV, dizzin...
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Extreme fatigue, burning muscles, bruising, night sweats, borderline low platelets, high MPV, dizziness, cannot exercise
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| 34 | 2021-02-22 | migraine, fever | I started experiencing high fever, (103) body aches, muscles, nauseated, diarrhea, and migraine. |
| 34 | 2021-02-22 | night sweats, body temperature increased, fatigue, chills |
I started having fatigue around 7 hours after the shot was administered. My temperature went up 1.5 ...
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I started having fatigue around 7 hours after the shot was administered. My temperature went up 1.5 degree. Then 14 hours later I had chills and aches. Then I woke up with night sweats that drenched my sheets and clothes. Then I had a stabbing pain in my chest on the left side.
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| 34 | 2021-02-22 | throat swelling | Numbness and tingling of face and lips that got progressively worse. Throat swelling |
| 34 | 2021-02-22 | headache, fatigue |
On Saturday morning I woke up with a headache and swollen lymph nodes in my neck/collarbone area. As...
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On Saturday morning I woke up with a headache and swollen lymph nodes in my neck/collarbone area. As the day progressed, I began to have pain in my joints and muscles. I felt very tired all day as well. I also experienced skin sensitivity which basically just made my skin hurt if anything/one touched me. Sunday my headache persisted, still had pain at injection site and felt warm to the touch. Swollen lymph nodes also still there and fatigue. Monday morning symptoms of headache, injection site pain and warmth and swollen lymph nodes still felt. Taking Tylenol to help with headache, warm compresses to help swollen lymph nodes and ice pack for injection site pain.
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| 34 | 2021-02-22 | headache |
This patient is a 34 y.o. female presenting to the emergency department with a chief complaint of an...
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This patient is a 34 y.o. female presenting to the emergency department with a chief complaint of anxiety onset 1130. The patient reports that she had her second dose of the COVID vaccine, and 4 minutes after, had chest tightness with palpitations. She had associated nausea, vomiting and a mild headache. She states that her symptoms come in waves and are similar to a panic attack. She has had panic attacks in the past. She reports that she had similar symptoms after her fist dose, but states that they were much more mild.
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| 34 | 2021-02-23 | shortness of breath, throat swelling | SOB, Hives, Reddness, Swelling in throat and lips. hoarseness and wheezing |
| 34 | 2021-02-24 | headache, fever |
Fever; headache; body aches; This is a spontaneous report from a contactable other healthcare profes...
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Fever; headache; body aches; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8983) intramuscular on the left arm on 27Jan2021 08:30 at a single dose for Covid-19 immunization. Medical history included allergies, sinus (disorder), hearing loss and allergies: shellfish and sulfa. The patient previously received first dose of BNT162B2 on 04Jan2021 for COVID-19 immunization (first dose, 04:00 PM Intramuscular on the left arm lot number: EL 0142). Concomitant medication included nigella sativa (black seed oil), turmeric [curcuma longa rhizome] and multivitamins. On 28Jan2021 05:00 AM, the patient experienced fever, headache and body aches. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Patient was not pregnant. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was unknown.
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| 34 | 2021-02-28 | headache |
Sore arm; mild headache; nausea; This is a spontaneous report from a contactable healthcare professi...
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Sore arm; mild headache; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at the right arm on 19Dec2020 08:45 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced sore arm, mild headache, and nausea after the first dose on an unspecified date with outcome of not recovered. The patient did not receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 34 | 2021-02-28 | fever |
intense body aches; fever; joint pain; several episodes of tachycardia; This is a spontaneous report...
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intense body aches; fever; joint pain; several episodes of tachycardia; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration on 09Jan2021 10:00 at a single dose on right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 19Dec2020 at 08:45 AM on right arm (lot number: EH9899) for COVID-19 immunization and experienced sore arm, mild headache/nausea. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Jan2021 20:00, the patient experienced intense body aches, fever, joint pain; and approximately 1 week after through more than 2 weeks after (Jan2021) had several episodes of tachycardia. No treatment was received for the adverse events. The patient has not recovered from the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious.
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| 34 | 2021-03-01 | fever |
On 02.24.21 in the evening I began experiencing body aches. The following day I had a fever of 100....
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On 02.24.21 in the evening I began experiencing body aches. The following day I had a fever of 100.8 and saw an Urgent Care provider who referred me to the hospital. Upon arrival my fever spiked to 102.3, bloodwork showed elevated lactate at 2.4 and pulse rate was over 119. I was admitted with sepsis symptomatology.
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| 34 | 2021-03-02 | dizziness, weakness, fatigue, sweating |
Elevated BP 166/99; Nausea; Heart palpitations hr 111; Heart palpitations hr 111; Sweating; Muscle c...
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Elevated BP 166/99; Nausea; Heart palpitations hr 111; Heart palpitations hr 111; Sweating; Muscle cramps; Swollen lymph nodes; Dizzy; Body weakness; Fatigue; Pain moving across my neck/chest/back; Pain moving across my neck/chest/back; pain moving across my neck/chest/back; Trouble sleeping; Pressure in my chest; Splotchy skin; This is a spontaneous report from a contactable other health professional reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration, on the left arm, on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included sinusitis, placenta accreta, infertility, caesarean section, seasonal allergy, sulfa allergy, and coriander allergy all from an unknown date. The patient did not have COVID-19 prior to vaccination. The patient is not pregnant. Concomitant medication included prednisone from an unspecified date. The patient previously took hydrocodone and experienced drug allergy. The patient previously received the first dose of BNT162B2 (lot number: EL1284) on 30Dec2020 for COVID-19 immunisation and experienced left arm completely numb and tingling for 4 weeks. No other vaccines were given in four weeks. On an unspecified date after the second shot, it was reported that the patient experienced elevated BP of 166/99, nausea, heart palpitations HR 111, sweating, muscle cramps, swollen lymph nodes, dizzy, body weakness, fatigue, pain moving across the neck/chest/back, trouble sleeping, and pressure in chest. On 30Jan2021, 10 days after the second vaccination, the patient experienced splotchy skin. The events resulted in doctor clinic visit and emergency room care. The patient was given an unspecified treatment for the events. The patient was tested for COVID-19 post vaccination via nasal swab on 26Jan2021 with a negative result. The vaccine was administered in the workplace clinic. The outcome of the events were reported as recovering.; Sender's Comments: A causal association between BNT162B2 and the reported elevated blood pressure cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 34 | 2021-03-02 | cold sweat, fever, fatigue, chills |
Fever; chills; cold sweats; extremely achy body to the point where it was difficult to lift myself o...
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Fever; chills; cold sweats; extremely achy body to the point where it was difficult to lift myself out of bed; extremely achy body to the point where it was difficult to lift myself out of bed; I also had extreme fatigue; I slept for almost 20 hours straight, and slept through work without waking up to call out; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1238), intramuscular from 28Jan2021 15:45 (03:45 PM), (at the age of 34-years-old) at single dose on left arm for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included bipolar 2 disorder (reported as "ipolar 2 disorder") and attention deficit hyperactivity disorder (ADHD). Patient has no allergies to medications, food and other products. Patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included lamotrigine (100 mg), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL; reported as "Adderall XR 15 mg") and quetiapine fumarate (50 mg). Patient did not received any other vaccines within 4 weeks prior vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as "Other". The patient received first dose of COVID-19 vaccine on 07Jan2021 01:00 PM (lot number: EH9899), intramuscular on the left arm. On 29Jan2021 02:00 AM, the patient experienced fever, chills, cold sweats, extremely achy body to the point where it was difficult to lift herself out of bed. The patient also had extreme fatigue. Patient slept for almost 20 hours straight, and slept through work without waking up to call out. No treatment was received for the events. The events were assessed as non-serious. Outcome of the events was recovered in 2021. Body temperature on 29Jan2021 with unknown results. Since the vaccination, the patient has not been tested for COVID-19
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| 34 | 2021-03-09 | headache, fever |
Onset of symptoms 1-2 days after 2nd Pfizer Dose. Presented to ER with fever, myalgia, headache, mil...
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Onset of symptoms 1-2 days after 2nd Pfizer Dose. Presented to ER with fever, myalgia, headache, mild thrombocytopenia/leukopenia, elevated hepatic function test. Also noted mild swelling of upper eyelids.
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| 34 | 2021-03-09 | chills, fever |
The mother was 38 Weeks pregnant at the onset of the event; Chills, aching at injection site, and lo...
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The mother was 38 Weeks pregnant at the onset of the event; Chills, aching at injection site, and low grade fever; Chills, aching at injection site, and low grade fever; Chills, aching at injection site, and low grade fever/Highest recorded fever 99.7 degrees F; This is a spontaneous report from a contactable other HCP. A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration from 02Feb2021 14:30 at SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient received first dose of BNT162B2 for COVID-19 vaccine on 12Jan2021 at 2:30pm in left arm. The patient's second dose was on 02Feb2021 and the patient was approximately 37 weeks pregnant. That night and the next day, on 04Feb2021 12:45, the patient had chills, aching at injection site, and low grade fever for which the patient took acetaminophen prn (as needed). Highest recorded fever 99.7 degrees F. The mother was 38 Weeks pregnant at the onset of the event. On Feb2021 at 12:50am, the patient's water broke 2.5 weeks before the due date. The patient was admitted to the local hospital and the baby was delivered without complications. Discharged on 05Feb2021. Unsure if early delivery related to vaccination, but thought it worth reporting since there is limited data on pregnant women and the vaccine. The patient underwent lab tests and procedures which included body temperature: low grade fever fahrenheit, body temperature: 99.7 fahrenheit on Highest recorded fever 99.7 degrees F, sars-cov-2 test: negative on 03Feb2021. Treatment was received for the event low grade fever. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 34 | 2021-03-11 | headache, dizziness, shortness of breath |
dizzy; blood pressure, it was "high", around 129/88; shortness of breath; urge to vomit (nausea); fa...
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dizzy; blood pressure, it was "high", around 129/88; shortness of breath; urge to vomit (nausea); faint; body aches; headache; her arm hurt; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 11Feb2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Pfizer's vaccine on Thursday, morning (11Feb2021), at the time her arm hurt. She had body aches the entire Friday (12Feb2021) and headache; she stayed in bed all day and the next day, she took Tylenol. On Saturday (13Feb2021), she had shortness of breath and the urge to vomit (nausea), she was about to faint. She was also dizzy and checked her blood pressure, it was "high", around 129/88, but she can't recall the values exactly. She doesn't know if she should get the second dose because she's scared. The patient wanted to know if these are symptoms from the vaccine or could it have been a reaction or allergy. She is scheduled for the second dose on 04Mar2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 34 | 2021-03-14 | throat irritation |
Numbness; itchy throat; tingling in face; trouble swallowing; hives on face and back; This 34- year-...
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Numbness; itchy throat; tingling in face; trouble swallowing; hives on face and back; This 34- year-old female patient contactable consumer (reported for herself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot En5318), via an unspecified route of administration, on 05Feb2021 at 01:30 PM (at the age of 34-years-old) as a single dose for COVID-19 immunization, in left arm. Historical Vaccine included first dose of BNT162B2 on 15Jan2021 at 10.45 (lot EL1484, expiry 30Apr2021), for COVID-19 immunization and experienced the onset of headache, intense arm pain at the injection site and mild joint pain. The patient's concomitant medications included The medical history included: Asthma, GERD, and obesity. Allergy to Sulfa. Historical Vaccine included first dose of BNT162B2 on 15Jan2021 (lot E63248), for COVID-19 immunization in left arm. The patient's concomitant medications included ALBUTEROL [SALBUTAMOL]. She has had no other vaccines in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Feb2021 13:45, she reported experiencing Numbness, tingling in face, trouble swallowing, itchy throat, hives on face and back. Patient received treatment of 3 doses of Benadryl. The outcome of the events Numbness, tingling in face, trouble swallowing, itchy throat, hives on face and back was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.
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| 34 | 2021-03-14 | influenza like illness, shortness of breath |
Pulmonary embolism: vaccine shot 2 administered 3/8, symptoms (shortness of breath, rapid heart beat...
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Pulmonary embolism: vaccine shot 2 administered 3/8, symptoms (shortness of breath, rapid heart beat) began 3/10, diagnosed at medical center 3/12. (Also experienced typical"flu like" symptoms beginning 12 hours after vaccine and lasting ~48 hours.) Being treated with anticoagulants.
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| 34 | 2021-03-15 | fever, headache, chills |
headache/headache at temples radiating to base of skull; Chills; Fever of 100.0; This is a spontaneo...
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headache/headache at temples radiating to base of skull; Chills; Fever of 100.0; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL3247), via an unspecified route of administration on right arm on 05Feb2021 09:00 AM at single dose for Covid-19 immunisation. Patient was not pregnant. Medical history was not reported. No other vaccine was received by the patient in four weeks. Other medications in two weeks included birth control. Past drug event included neosporin allergy. 12 hours after injection on 05Feb2021 at 21:00 PM, the patient experienced headache at temples radiating to base of skull, chills, fever of 100.0. No treatment received for events. Patient didn't have Covid prior vaccination. No Covid tested was done post vaccination. Outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
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| 35 | 2020-12-31 | shortness of breath |
After receiving the vaccine I began to feel lightheaded and short of breath. I felt tachycardiac and...
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After receiving the vaccine I began to feel lightheaded and short of breath. I felt tachycardiac and felt like passing out. I got transferred to the er where I received the epipen along with oxygen and antiseizure meds for my seizure. I was then transferred to Medical Center for further care where I was later discharged.
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| 35 | 2020-12-31 | dizziness, fever, chills | Dizziness, chills, fever, muscle aches, pain at the injection site |
| 35 | 2020-12-31 | headache |
Mild headache starting about 4 hours after dose. Took Tylenol 500mg PO every 4 hours x three doses. ...
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Mild headache starting about 4 hours after dose. Took Tylenol 500mg PO every 4 hours x three doses. Went away overnight. Came back in the afternoon again for 5-6 hours.
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| 35 | 2020-12-31 | fatigue, chills |
No immediate events. But about 24 hours after vaccination I felt extreme tiredness and some chills w...
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No immediate events. But about 24 hours after vaccination I felt extreme tiredness and some chills which I read is normal but I noticed tingling in my legs. And a cold sensation. No weakness and it resolved in about an hour. Then today 1/1/2021 numbness and tingling/pins and needles in my feet and legs . It lasted a few hours and mostly resolved. I was not sure if there was a possibility of guillian barre occurring post this .
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| 35 | 2020-12-31 | fatigue |
Within the first 15 minutes of receiving the vaccine I was was extremely tired. As time went on, th...
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Within the first 15 minutes of receiving the vaccine I was was extremely tired. As time went on, this seemed to subside. Tiredness has appeared to come and go over the last few days. Every morning I have woken up with tingling in my left hand, as though there are pins and needles in my left hand. My left arm feels weaker and feels some numbness when more pressure is placed on it. I have a bruise that appeared above my left wrist. I have reached out, as this is my employer and I have not heard back. Assuming they were closed due to New Year?s Day.
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| 35 | 2021-01-01 | headache, cough, chills |
Moderate headache at night 12/30/20 Dry cough nonpersistent (AM), chills (PM) 12/31/20 Lost of taste...
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Moderate headache at night 12/30/20 Dry cough nonpersistent (AM), chills (PM) 12/31/20 Lost of taste/smell 01/02/21
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| 35 | 2021-01-02 | fatigue, headache |
12/23/20: within 2 minutes of receiving the vaccine I felt pulsing in my left wrist and weakness in ...
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12/23/20: within 2 minutes of receiving the vaccine I felt pulsing in my left wrist and weakness in my left hand, within 30 minutes my left ear felt like it needed to pop, I had the normal/expected side effects for the first 1-2 days (very sore arm, headache, achy, fatigue, mild joint pain) 12/24/20: weakness/numbness/cold feeling in my left lower leg and foot, fullness in left ear continued 12/27/20: same sx as 12/24, plus weakness/numbness in left forearm, pinky and ring finger 12/28/20: same sx as above, plus fullness in R earned weakness/numbness in right forearm, pinky, and ring finger 12/30/20: same sx as above, plus weakness/numbness on the left side of my face, no drooping 12/31/20: same sx as above, now with weakness/numbness/cold sensations on both sides of face (although only one side at a time), in both legs, both arms down into pinky and ring fingers (weakness noticed when typing and writing). Both ears still with fullness feeling (only one side at a time). I can still walk/run, these symptoms are still present as of today 1/3/21.
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| 35 | 2021-01-02 | headache | Moderate headache that will not go away no matter what medications are taken. |
| 35 | 2021-01-02 | fever, headache, malaise |
Woke up Friday, 1/01, with sinus pain. Specifically burning pain in my sinuses and pain when I moved...
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Woke up Friday, 1/01, with sinus pain. Specifically burning pain in my sinuses and pain when I moved my eyes from right to left. Also had a generalized headache and body aches. On Saturday, 1/02, did have a fever of 100.2 but this has resolved. This morning, 1/03, the sinus pain has improved, still a slight headache and now major conplaint is lower back pain. Also have general malaise. No fever today either.
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| 35 | 2021-01-03 | headache, fatigue |
Headache; Fatigue; The patient received BNT162B2 and was lactating; The patient received BNT162B2 an...
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Headache; Fatigue; The patient received BNT162B2 and was lactating; The patient received BNT162B2 and was lactating; This is a spontaneous report from a contactable healthcare professional reporting for herself and her baby. This is the maternal report. A 35-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EH9899) intramuscular, on 16Dec2020 at 10:00, in right arm, for COVID-19 immunisation. No other vaccine was given within 4 weeks before. The patient was breastfeeding. Allergies to medications, food, or other products: no. The patient had no COVID before vaccination. Concomitant medications included ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS), vitamin D and calcium. The patient was lactating and on 17Dec2020 her baby seemed to have had an upset stomach, she had trouble sleeping and spit up a few times which was abnormal for her. On 17Dec2020 the patient experienced headache and fatigue which both resolved with lasting effects on an unspecified date in Dec2020. Treatment included paracetamol (TYLENOL). Since the vaccine she had had a headache daily. The events required physician office visit. COVID was not tested after vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020511585 baby case
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| 35 | 2021-01-03 | shortness of breath, sweating, dizziness |
I am an APRN, and received the vaccine not quite one week ago. I waited 15 minutes within the facili...
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I am an APRN, and received the vaccine not quite one week ago. I waited 15 minutes within the facility and then left. Sat in my car working for about 8-10 minutes when a sudden rush of heat ran through my body. I felt lightheaded, my tongue was prickly, and I felt like I was going to pass out. I was able to get back into the facility to let them know of the sudden symptoms. At that time I felt like my heart was racing and was diaphoretic. They continued to watch me for another 15-20 minutes, they did have an epi pen but it was not given. I was feeling slightly better and then left again. I waited in my car approximately 20 minutes before deciding it would be safe to drive away. After driving for about 10 minutes I had another rush of heat, lightheadedness, and then I started having shortness of breath. At this time it would have been about 1 hour, maybe longer, since receiving the vaccine. I was not close to an emergency medical facility at that time, and did not feel like my throat was swelling so thought it would be best to try to drive to the nearest ER. I knew I had an epi pen from my work that I could use if needed. I contacted another nurse practitioner who I work with who stayed on the phone with me until I was able to get to a safe place. At that time the symptoms had improved, not resolved. It had been able 20 minutes during this episode. In all, I continued to feel jittery for about 3-4 more hours. Since my symptoms did improve I did not go to the ER. I contacted my health department, Louisville health dept, the following day and reported symptoms to the medical director.
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| 35 | 2021-01-03 | headache, fever | Left arm soreness, Headache 30 mins after, Fever 100.9 T 5am and 9am, monitoring until now |
| 35 | 2021-01-03 | dizziness | Lightheadedness and heart palpatations |
| 35 | 2021-01-03 | skin warm | Moderate local reaction. Swelling, redness, pain, hot to touch, itchy for 5+ days. |
| 35 | 2021-01-03 | fatigue |
Severe fatigue 2 hours after the shot lasting for 36 hours. Pain throughout the upper arm that recei...
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Severe fatigue 2 hours after the shot lasting for 36 hours. Pain throughout the upper arm that received the injection lasting for 36 hours treated with Advil.
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| 35 | 2021-01-04 | weakness, dizziness, fatigue |
10 minutes after receiving vaccination, patient reported rapid heart rate, fatigue, felt weak, hot, ...
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10 minutes after receiving vaccination, patient reported rapid heart rate, fatigue, felt weak, hot, and palpitations. Patient reported tachycardia with heart rate 160-170's. Transient numbness to hands and perioral region. Presented to ED, was monitored with resolution of symptoms. On 1/4/21 patient presented to ED with tachycardia with HR up to 160s, Episode was severe, causing lightheadedness, "throat squeezing", with bilat UE paresthesias. Episode lasted 20 minutes. Patient evaluated in ED and discharged with outpatient follow up with cardiology and endocrinologist.
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| 35 | 2021-01-04 | fatigue, headache, dizziness |
Dizziness; Metallic taste upon injection; Sore arm; Headache; Muscle aches; Fatigue; This is a spont...
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Dizziness; Metallic taste upon injection; Sore arm; Headache; Muscle aches; Fatigue; This is a spontaneous report from a contactable healthcare professional. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on the left arm on 30Dec2020 14:00 at a single dose for COVID-19 immunisation. Medical history included hypertension (List of any other medications the patient received within 2 weeks of vaccination: Hypertension medication). On 30Dec2020 14:00, the patient experienced dizziness, metallic taste upon injection, sore arm, headache, muscle aches and fatigue. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 35 | 2021-01-04 | fatigue |
Estimated delivery date 05/09/2021. I had extreme fatigue and I had some trouble walking it flared m...
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Estimated delivery date 05/09/2021. I had extreme fatigue and I had some trouble walking it flared my osteoarthritis. I decided to stay home and work from home since I was having trouble walking, the next day I felt fine.
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| 35 | 2021-01-04 | fatigue, fever, throat pain, headache |
Feverish; Severe arm pain; Severe arm pain and decreased mobility; Headache; Fatigue; Sore throat; B...
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Feverish; Severe arm pain; Severe arm pain and decreased mobility; Headache; Fatigue; Sore throat; Body aches; This is a spontaneous report from a contactable Nurse(patient). A 35-year-old female patient received first dose (BNT162B2, Lot number Eh9899), via an unspecified route of administration on 28Dec2020 17:30 at 35 years old at Arm Left at single dose for COVID-19 immunization. The medical history included Allergies to Penicillin. The concomitant medications were none. On 28Dec2020 21:30 the patient experienced Severe arm pain, decreased mobility, Headache, Fatigue, Sore throat, Body aches, Feverish. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The information on the batch number has been requested.
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| 35 | 2021-01-04 | throat pain, headache, chills, fatigue |
Headache; Fatigue; Muscle and joint pain; joint pain; Chills; heat surges; Sore throat; Not wanting ...
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Headache; Fatigue; Muscle and joint pain; joint pain; Chills; heat surges; Sore throat; Not wanting to eat; Sore; Heart bothered me a little today; This is a spontaneous report from a contactable other Health Professional (Other HCP) (patient). A 35-year-old female Patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Ek9231) on 29Dec2020 10:30 AM, Intramuscularly, (vaccine location: Left arm) at single dose (first dose) for COVID-19 immunization. Medical history included Mitral valve prolapse (Mvp) and covid (patient had covid prior vaccination). Concomitant medication included naproxen a week before. Patient was allergic to Azithromycin. Patient received no other vaccine in four weeks. Patient experienced Headache, Fatigue, Muscle and joint pain, Chills and heat surges, Sore throat, Not wanting to eat, Sore, Heart bothered me a little today (29Dec2020 11:15). Patient did not receive any treatment. Patient did not have had covid tested post vaccination. The outcome of the events was unknown. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 35 | 2021-01-04 | malaise |
I am not feeling well; had a Covid PCR done swapped on yesterday and I am Covid positive; had a Covi...
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I am not feeling well; had a Covid PCR done swapped on yesterday and I am Covid positive; had a Covid PCR done swapped on yesterday and I am Covid positive; This is a spontaneous report from a contactable nurse. This nurse reported for herself that the 35-year-old female patient who received bnt162b2 (BNT162B2), via unknown route of administration on 23Dec2020 at single dose for covid-19 immunisation. Medical history was none. Concomitant medications were none. Nurse stated, "I received the Pfizer Vaccine this Wednesday and right before getting the vaccine, I had a Covid test (captured as per verbatim) on before the vaccine on Tuesday (22Dec2020) was negative. I had a Covid PCR done swapped on yesterday (25Dec2020) and I am Covid positive. So I have the vaccine and I am Covid positive" Nurse stated "It's "140" "130" pounds (further bot clarified)." The patient was not feeling well. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the SARS-CoV-2 test positive and vaccination with BNT162B2 cannot be excluded.
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| 35 | 2021-01-04 | fever, fatigue |
Left arm swelling and tingling within 2 hours of injection, swollen lymph nodes in neck the followin...
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Left arm swelling and tingling within 2 hours of injection, swollen lymph nodes in neck the following morning, within 72 hours severe abdominal pain, nausea, vomiting, and diarrhea that lasted 5 days, fatigue, and low grade fever (no higher than 100.8)
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| 35 | 2021-01-04 | headache |
Nausea; body aches; headache; unable to sleep; This is a spontaneous report from a non-contactable n...
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Nausea; body aches; headache; unable to sleep; This is a spontaneous report from a non-contactable nurse, the patient. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Eh9899) solution for injection in the left arm on 29Dec2020 at 14:00 (at the age of 35-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included asthma, pituitary adenoma, IBS (irritable bowel syndrome) and COVID (prior to vaccination). Concomitant medications were unknown. Past drug history included known allergies: ciprofloxacin hydrochloride (CIPRO). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. In Dec2020, the patient experienced nausea, body aches, headache and unable to sleep. No treatment was provided for the events nausea, body aches, headache and unable to sleep. The outcome of the events nausea, body aches, headache and unable to sleep was recovering. Since the vaccination, the patient has been tested for COVID-19 via nasal swab on 30Dec2020 and result was pending. No follow-up attempts are possible. No further information is expected.
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| 35 | 2021-01-04 | headache |
Pain on the right side of my head; This is a spontaneous report from a contactable consumer (patient...
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Pain on the right side of my head; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient started to receive BNT162B2 (lot number: EH9899), via an unspecified route of administration on 21Dec2020 at SINGLE DOSE for exposure to COVID. There were no medical history. Concomitant medication included ibuprofen (ADVIL) and unspecified birth control. The patient experienced pain on the right side of her head on an unspecified date. No treatment received for the event. The outcome of the event was unknown.
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| 35 | 2021-01-04 | malaise |
Patient reported burning at the injection site shortly after receiving vaccine. She had a burning /...
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Patient reported burning at the injection site shortly after receiving vaccine. She had a burning / swelling sensation of her tongue and otherwise felt unwell. She was placed on a cardiac monitor which showed ST with a VR 142-155, no ectopy. She reports that her HR is usually 130 or less. She had a BP that ranged between 149-160/96-105. She reports this is elevated for her. Patient sent to ED and given Benadryl and prednisone for 3 days. On 1/4, patient contacted MD and stated injection site is red and raised. Continues to take Benadryl and prednisone and has a numb and swollen tongue.
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| 35 | 2021-01-04 | headache |
mild headache; This is a spontaneous report from a contactable nurse (patient). This 35-year-old fe...
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mild headache; This is a spontaneous report from a contactable nurse (patient). This 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot GJ1685), via an unspecified route of administration, on 22Dec2020 (reported also as 23Dec2020, to be clarified) at 3:00 PM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at Nursing Home/Senior Living Facility, age at vaccination was 35-years-old. No other vaccine was received in four weeks. Medical history and concomitant medications were unknown. On 22Dec2020 at 07:00 PM, the patient got mild headache. The event was reported as non-serious. The patient was tested for Covid post vaccination through a nasal swab in Dec2020 and was negative. Outcome was recovered on Dec2020. No treatment was received for the event.
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| 35 | 2021-01-05 | chills |
AS REPORTED BY PATIENT: Monday 12-28 evening I begun to get chills and body aches, the next morning...
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AS REPORTED BY PATIENT: Monday 12-28 evening I begun to get chills and body aches, the next morning when waking up I felt like a truck hit me. Starting Tuesday morning, for three days, I got calf/feet cramps that were non-stop. I did call my doctor and got lab work done on 12-31. This lab work showed some kidney values that were off. Starting Sunday my legs and feet swelled up. I had a routine MS appointment on Monday and they stated since there is no data for folks with MS and the vaccine that they cannot rule out the vaccine is playing a role in some of this along with the IVIG. I did follow up with my primary care doctor on Tuesday and they re did lab work as well as did a ultrasound to rule out blood clots. She did state she felt like it was the perfect storm between the COVID vaccine and then the Immunoglobins that I am on. She suggested I download the app for CDC and report those items as well. The doctors are still suggesting I get the 2nd shot just have to do some things prior to the second shot.
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| 35 | 2021-01-05 | chills |
DESCRIPTION THAT FOLLOWS IS FROM PATIENT: Monday 12-28 evening I begun to get chills and body aches,...
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DESCRIPTION THAT FOLLOWS IS FROM PATIENT: Monday 12-28 evening I begun to get chills and body aches, the next morning when waking up I felt like a truck hit me. Starting Tuesday morning, for three days, I got calf/feet cramps that were non-stop. I did call my doctor and got lab work done on 12-31. This lab work showed some kidney values that were off. Starting Sunday my legs and feet swelled up. I had a routine MS appointment on Monday and they stated since there is no data for folks with MS and the vaccine that they cannot rule out the vaccine is playing a role in some of this along with the IVIG. I did follow up with my primary care doctor on Tuesday and they re did lab work as well as did a ultrasound to rule out blood clots. She did state she felt like it was the perfect storm between the COVID vaccine and then the Immunoglobins that I am on. She suggested I download the app for CDC and report those items as well. The doctors are still suggesting I get the 2nd shot just have to do some things prior to the second shot.
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| 35 | 2021-01-05 | body temperature increased, chills, fatigue, headache |
Headache noted the night of vaccine and continues to present time. General fatigue noted 1/5/21 with...
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Headache noted the night of vaccine and continues to present time. General fatigue noted 1/5/21 with some body aches. Around 4:30pm on 1/5/21 took 1g acetaminophen for headache. At 5pm 1/5/21 temperature of 99.4 noted. By 6pm 1/5/21 temperature was 99.9 (despite acetaminophen in system). Difficulty sleeping 1/5/21 and awoke with intense chills followed a couple hours later with sweats and temp 100.3. Increased sinus congestion also noted, unrelieved by Sudafed.
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| 35 | 2021-01-05 | headache | Headache, mental fog |
| 35 | 2021-01-05 | night sweats |
I woke up with my eyes ever swollen and red (only my eyelids); I woke up with my eyes ever swollen a...
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I woke up with my eyes ever swollen and red (only my eyelids); I woke up with my eyes ever swollen and red (only my eyelids); they were still red and painful; My eyes were slightly puffy the next morning but nothing alarming; Night sweats that were worst the night of the vaccination; This is a spontaneous report from a contactable nurse reporting for herself. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 29Dec2020 17:00 at single dose in the left arm for COVID-19 immunization. Medical history included none. No known allergies. No other vaccine in four weeks. Concomitant medication included fluoxetine hydrochloride (PROZAC). Prior to vaccination, the patient was diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19. The patient experienced night sweats that were worst the night of the vaccination. Her eyes were slightly puffy the next morning (30Dec2020) but nothing alarming, however, Thursday morning (31Dec2020 06:00) she woke up with her eyes ever swollen and red (only her eyelids). Thursday evening she'd been able to get the swelling down but they were still red and painful (after diphenhydramine hydrochloride (BENADRYL)). The events were non-serious. Employer and provider of vaccine had no protocol in place and said to treat it like any other reaction and go to ER if it worsened. The events were not resolved.
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| 35 | 2021-01-05 | headache |
I woke up with significant vertigo and nausea. The vertigo subsided after about 30 minutes. The naus...
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I woke up with significant vertigo and nausea. The vertigo subsided after about 30 minutes. The nausea continued throughout the day. Increased nausea with looking down or quick movements throughout the day. Headache that day as well. Intermittent mild nausea the following day. No other sick contacts.
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| 35 | 2021-01-05 | headache, fatigue |
Injection site arm soreness, bad headache, fatigue that began about 6 hours after the vaccine and th...
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Injection site arm soreness, bad headache, fatigue that began about 6 hours after the vaccine and then lasted for 24 hours, but improved over time
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| 35 | 2021-01-05 | headache |
Noted had history of various allergies. Received vaccine at 6:06 pm and about 10 minutes later note...
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Noted had history of various allergies. Received vaccine at 6:06 pm and about 10 minutes later noted headache. BP 150/70; p 86. Then neck pain, bilateral leg soreness, and hip pain; R foot tingling, felt warm, itching, no rash noted. Treated with 25mg benadryl at 0624 pm; BP 130/82. And went to ED for evaluation via wheelchair/personnel.
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| 35 | 2021-01-05 | dizziness |
Progress Notes PA-C (Physician Assistant) ? ? Physician Assistant Cosign Needed Expand All Collapse ...
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Progress Notes PA-C (Physician Assistant) ? ? Physician Assistant Cosign Needed Expand All Collapse COVID VACCINE CLINIC 1/6/2021 Date: 1/6/2021 Subjective Patient is a 35 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She denied any history of previous adverse reactions to vaccines. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience dizziness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea and increased work of breathing, skin changes, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: All other systems negative Patient complains of dizziness Objective Vitals Vitals: 01/06/21 1216 01/06/21 1229 BP: 124/81 117/81 Pulse: 76 69 SpO2: 99% 100% BS not done; no diabetes or history of hypoglycemia. NO allergies. Physical Exam Vitals signs reviewed. Constitutional: Appearance: Normal appearance. She is normal weight. HENT: Head: Normocephalic. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Palpations: Abdomen is soft. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert. Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP. Patient rested on gurney with head elevated for approximately 15 minutes with symptoms resolving without intervention other than water. PA-C Electronically Signed 1/6/2021 12:29 PM
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| 35 | 2021-01-05 | fever, headache |
Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), art...
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Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; This is a spontaneous report from a Non-contactable Physician (patient). A 35-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration on 23Dec2020 at first single dose at arm left for covid-19 immunisation. The patient received the vaccine at hospital. Medical history included migraine, dermatitis atopic. The patient's concomitant medications were not reported. The patient experienced Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache on 24Dec2020. No treatment for events. The outcome of events was recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination. No follow-up attempts are possible. No further information is expected.
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| 35 | 2021-01-05 | headache |
Severe Headache, Vomiting, Lymph node swelling in left arm Took tylenol and Meloxicam-little relief ...
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Severe Headache, Vomiting, Lymph node swelling in left arm Took tylenol and Meloxicam-little relief from symptoms
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| 35 | 2021-01-05 | throat swelling |
This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-yea...
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This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK5730, via an unspecified route of administration on 29Dec2020 at 13:30 (at the age of 34 years old) as a single dose in the right arm. Medical history included fibromyalgia, anxiety disorder, and allergy to amoxicillin from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included omeprazole 40mg and duloxetine 120 mg, both for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 29Dec2020 at 18:30, the patient experienced severe body aches, chills, minor headache, and swollen lymph nodes on neck. On 30Dec2020, the patient experienced productive cough. The patient did not receive treatment for the events. The clinical outcome of body aches, chills, minor headache, swollen lymph nodes on neck, and productive cough was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 35 | 2021-01-05 | fatigue |
fatigue; Yellow urine; injection site pain; This is a spontaneous report from a contactable pharmaci...
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fatigue; Yellow urine; injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 35-year-old female patient received the first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: BL0142), intramuscular on the left arm on 31Dec2020 at 19:30 at a single dose for immunization. Medical history was not reported. There were no concomitant medications. The patient had no other vaccine in four weeks, no Covid prior vaccination and has not been tested positive for Covid post vaccination. The patient had yellow urine, injection site pain, and fatigue on 01Jan2021, and received Tylenol or ibuprofen as treatment for the events. The events had not resolved.
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| 35 | 2021-01-05 | sweating, dizziness |
within 5 minutes of receiving vaccine became hot and flushed, diaphoretic, nauseated, lightheaded, a...
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within 5 minutes of receiving vaccine became hot and flushed, diaphoretic, nauseated, lightheaded, and felt faint
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| 35 | 2021-01-06 | headache, nerve pain |
1. Noticing a sharp headache for about 10 seconds either in the occipital lobe region or temporal lo...
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1. Noticing a sharp headache for about 10 seconds either in the occipital lobe region or temporal lobe region on the right side of my head every now and then. It has happened about 8 times since vaccine administration. The first time being about 25-30 minutes after vaccination. 2. I have also noticed a sharp pain in the back of my right thigh/upper buttock region that feels either like a nerve or muscle pain. It usually is most noticeable when I first stand up from a sitting position or laying position. If I don't put as much pressure on the heel of my right foot, it isn't as bad and ibuprofen has helped the pain subside, but it has been constant. This was first noticed about 4-5 hours after vaccination received.
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| 35 | 2021-01-06 | headache, fever, fatigue, chills |
12 hours post vaccination woke up and barely could lift right arm, chills, body aches, headache, fev...
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12 hours post vaccination woke up and barely could lift right arm, chills, body aches, headache, fever 99.8, extreme fatigue for about 18 hours. Took 650 mg with 800 mg Motrin twice. Symptoms resolved after 18 hours. Fatigue lasted for over 24 hours.
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| 35 | 2021-01-06 | dizziness |
35 y.o female present to the ER after receiving the first dose to her COVID 19 vaccine. Initially e...
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35 y.o female present to the ER after receiving the first dose to her COVID 19 vaccine. Initially experiencing a metallic taste in her mouth, palpitations, and nausea. She felt lightheaded but did not lose consciousness. Her symptoms rapidly improved. Her vital signs remained normal.
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| 35 | 2021-01-06 | fever, headache, fatigue, chills |
All mild symptoms in list except stomach issues. Fever, joint and muscle pains, headache, exhaustion...
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All mild symptoms in list except stomach issues. Fever, joint and muscle pains, headache, exhaustion, chills
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| 35 | 2021-01-06 | fever |
C/o fever of 101 next day. Treatment include Tylenol. Symptoms resolved. Patients feels much better ...
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C/o fever of 101 next day. Treatment include Tylenol. Symptoms resolved. Patients feels much better has been return back to work.
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| 35 | 2021-01-06 | headache, throat pain, fever, chills | Chills, headache, fever, sore throat |
| 35 | 2021-01-06 | headache, dizziness | Dizziness, Headache & NauseaVomiting |
| 35 | 2021-01-06 | chills, fatigue, fever |
Fever 102.4, severe fatigue, chills, aches, HA; Tylenol with reduced fever. Fever for 24 hours, sym...
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Fever 102.4, severe fatigue, chills, aches, HA; Tylenol with reduced fever. Fever for 24 hours, symptoms gradually resolved in 3 days from initiation.
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| 35 | 2021-01-06 | headache, throat pain, fatigue |
HEADACHE, EXTREME FATIGUE ON WEDNESDAY AND BOTH WORSED THEN DEVELOPED ON SUNDAY MUSCLE ACHES, DIARR...
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HEADACHE, EXTREME FATIGUE ON WEDNESDAY AND BOTH WORSED THEN DEVELOPED ON SUNDAY MUSCLE ACHES, DIARRHEA, SORE THROAT WENT TO URGENT CARE ON 12/29/2020 (TUESDAY) TESTED FOR STREP AND COVID
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| 35 | 2021-01-06 | lethargy, fever, shortness of breath, fatigue |
Myalgia, Fever, Diarrhea, Tachycardia, chest tightness, SOB, 12/29 After vaccination felt chest tigh...
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Myalgia, Fever, Diarrhea, Tachycardia, chest tightness, SOB, 12/29 After vaccination felt chest tightness, shortness of breath, tingling in her throat, heart racing. She stayed and was monitored for an hour. When she got home she took Benadryl which helped her sleep. She continues to have mild shortness-of-breath today. Her left arm is sore and she has body aches. Her temp is 100.6 today. 12/30 1712: While speaking on the phone with her she is speaking in full sentences without apparent dyspnea. 12/31 had bad night - high fever 101.5 at 0100 overnight last night. This morning feels tired, lethargic, and no appetite. She still has body aches. No fever this morning. 1/4 - employee reports she is doing much better today. She says she had a rough weekend but is much better today. She able to get back to her running usually runs 25 miles/week.
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| 35 | 2021-01-06 | chills, weakness, dizziness, headache, fever | Woke up with chills, headache, weak, felt like fainting, arm pain. Called off work. Fever of 100.4. |
| 35 | 2021-01-06 | headache, fatigue | severe back pain, headache, injection site reaction, fatigue, chills |
| 35 | 2021-01-06 | sweating, dizziness | tachycardia, sweating, dizziness and nausea. |
| 35 | 2021-01-07 | body temperature increased | AT APPROXIMATELY 2:00PM, DEVELOPED TEMPERATURE (100.5), REMAINED ELEVATED AT 3:35PM SAME DAY. |
| 35 | 2021-01-07 | headache, fatigue | Body aches, fatigue, headache |
| 35 | 2021-01-07 | headache, chills | Chills, muscle pain, headache, pain at injection site |
| 35 | 2021-01-07 | dizziness |
Dizziness Narrative: employee felt light headed after vaccine, no interventions, passed quickly fel...
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Dizziness Narrative: employee felt light headed after vaccine, no interventions, passed quickly felt better after 20min wait time
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| 35 | 2021-01-07 | sweating, dizziness |
Dizziness, NauseaVomiting, While being monitored, pt ran to the bathroom and then was observed holdi...
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Dizziness, NauseaVomiting, While being monitored, pt ran to the bathroom and then was observed holding onto wall/divider, "felt like might fall down" "tingling in left arm and leg", sweating. BP 100/80 PR 80, 115/87 PR 77, reports has drank 30-40 oz of water in the morning prior Narrative: Rapid Response called
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| 35 | 2021-01-07 | fever, chills, fatigue |
Fever (101F), chills, nausea, myalgias, injection site soreness extending to shoulder and down to el...
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Fever (101F), chills, nausea, myalgias, injection site soreness extending to shoulder and down to elbow, fatigue
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| 35 | 2021-01-07 | headache |
Headache, right hand numbing and tingling, stiff neck; Headache, right hand numbing and tingling, st...
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Headache, right hand numbing and tingling, stiff neck; Headache, right hand numbing and tingling, stiff neck; Headache, right hand numbing and tingling, stiff neck; Headache, right hand numbing and tingling, stiff neck; This is a spontaneous report from a non-contactable other healthcare professional. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On an unspecified date, the patient experienced headache, right hand numbing and tingling, and stiff neck. The patient did not receive treatment for the events. Outcome of the events was unknown. The patient underwent post vaccination nasal swab with an unknown result. No follow up attempts are possible. Information about lot/batch number cannot be obtained.
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| 35 | 2021-01-07 | dizziness |
I started a little dizzy after the vaccine but could have been my cycle. Later that evening my arm w...
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I started a little dizzy after the vaccine but could have been my cycle. Later that evening my arm was soar and swollen. I didn't take anything, a little difficult to sleep. The next day it started wearing off, I did ice the area.
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| 35 | 2021-01-07 | chills, fever | Injection site soreness, fever 101F, chills/rigors, severe nausea |
| 35 | 2021-01-07 | dizziness, weakness |
Left hand weakness and tingling, dizziness, injection site throbbing 10 min post vax Observation, fl...
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Left hand weakness and tingling, dizziness, injection site throbbing 10 min post vax Observation, fluids, food Sxs largely resolved after 30 mins of close monitoring, returned to shift feeling a little lightheaded NKA
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| 35 | 2021-01-07 | sweating |
Locked up for about 1-2 minutes then became diaphoretic Narrative: Employee was taken to the emergen...
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Locked up for about 1-2 minutes then became diaphoretic Narrative: Employee was taken to the emergency department for further assessment. Came to after going into a state of "locked up" for about 1-2 minutes, then became diaphoretic. After 1-2 minutes, employee was able to speak, was alert and oriented and was transported for further evaluation to our ED. She was able to provide us with her personal information to submit this report.
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| 35 | 2021-01-07 | chills, fatigue, headache |
Received vaccine on 1/6. Woke up on 1/7 at 1 AM with severe headache and chills. Took ibuprofen, whi...
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Received vaccine on 1/6. Woke up on 1/7 at 1 AM with severe headache and chills. Took ibuprofen, which helped. The chills lasted for a couple hours. Still has slight headache and fatigue on 1/8.
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| 35 | 2021-01-07 | nasal congestion, throat pain, headache, fatigue | Sever headache fatigue sore throat cough & congestion & I was unable to work on Christmas eve |
| 35 | 2021-01-07 | chills, dizziness | Severe Light headedness and dizziness lasted for about 4 days Headache , Muscle ache , Chills |
| 35 | 2021-01-07 | headache, fever |
fever 101; myalgias; arthralgias; headache; injection site pain; This is a spontaneous report from a...
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fever 101; myalgias; arthralgias; headache; injection site pain; This is a spontaneous report from a contactable physician. A 35-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular in the left arm on 22Dec2020 16:00 at single dose for covid-19 immunisation. Medical history included autoimmune thyroiditis, allergy to Sulfa and amoxicillin; clavulanic acid (AUGMENTIN). The patient had concomitant medications. On 23Dec2020 04:0 the patient experienced fever 101, myalgias, arthralgias, headache and injection site pain with outcome of recovered. The patient received paracetamol (TYLENOL) and Ibuprofen as treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
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| 35 | 2021-01-07 | fever | fever, diarrhea, chest pain |
| 35 | 2021-01-07 | malaise |
patient received vaccine at 16:45 and moved to observation area. prior to vaccine patient reported t...
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patient received vaccine at 16:45 and moved to observation area. prior to vaccine patient reported that she faints when she gets shots, in the observation area at 16:50 reported she felt nauseated and not well. patient sitting down, elevated feet, bp 143/85, hr 94, o2 sat 96%, drinking water, no reports of swelling, racing heart, shortness of breath. 17:00 glucometer 122, bp 147/97. hr 90, o2sat 98%, patient says she feels nauseated, drinking gingerale. 17:30 patient feet on floor and says she does not feel dizzy. 17:50 patient walking around and reports mild nausea
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| 35 | 2021-01-07 | dizziness, fatigue, fever, headache |
severe dizziness, chest palpitations, extreme muscle weakness, projectile vomiting- all x15 minutes,...
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severe dizziness, chest palpitations, extreme muscle weakness, projectile vomiting- all x15 minutes, followed by fever of 101.1 after tylenol. general fatigue, headaches for rest of day
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| 35 | 2021-01-07 | fever, chills |
test positive for COVID-19/fever, chills, body aches, joint pain; test positive for COVID-19/fever, ...
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test positive for COVID-19/fever, chills, body aches, joint pain; test positive for COVID-19/fever, chills, body aches, joint pain; This is a spontaneous report from a contactable other HCP. A 35-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5703), via an unspecified route of administration in left arm on 15Dec2020 17:30 at a single dose for covid-19 immunization. Administration was done in the hospital. Medical history included seronegative rheumatoid arthritis and allergies to latex and actemra. Concomitant medication included tofacitinib citrate (XELJANZ), and ibuprofen. Eight days after vaccination, on 23Dec2020 at 13:30, the patient came down with fever, chills, body aches, joint pain. The patient was initially tested negative for COVID (nasal swab) and influenza on 27Dec2020 but did test positive for COVID-19 on 29Dec2020 (nasal swab). The patient stated that she knew that the vaccine did not cause COVID however as she was on immunosuppressants (Xeljanz), she wanted to record this information. There was no treatment included for the events. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.
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| 35 | 2021-01-08 | shortness of breath |
30+ minutes after getting covid vaccine, severe chest tightness, hard time breathing in, was driving...
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30+ minutes after getting covid vaccine, severe chest tightness, hard time breathing in, was driving home and it kept getting worse. Chest pressure. Stopped in local er and got checked out.
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| 35 | 2021-01-08 | throat irritation |
? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her th...
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? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her throat is warm and scratchy, and her left hand felt cold. ? I escorted her over to the ER and she was checked in. I then went right back to HD since we were so busy. ? Around 4pm in the afternoon after we closed HD, I went back to the ER. She was recovering and doing fine. Her ER nurse and patient did have a question about receiving the 2nd dose, and I provided the same answer that Dr provided to Dr about taking an Allegra 30 minutes before the second dose. ED Note: Patient presents with symptoms concerning for angioedema or anaphylaxis after immunization with Covid vaccine. Patient described a sensation of warmth and also later tingling in her throat which was treated aggressively with medication for this problem so as to prevent airway closure or further worsening symptoms. Patient was treated with IV fluid hydration along with H1 and H2 blockers, IV steroids and also subcutaneous epinephrine. On my reevaluation, her symptoms completely resolved with treatment. She was without other concerning findings on examination or by history and was without further angioedema or anaphylaxis after period of observation. She was discharged with prescription medication in good condition and asked to return should she have any further problems. Immpression: Angioedema, allergic reaction to vaccine, throat tingling, throat warmth MEDS in ED: Sodium Chloride 0.9% (Sodium Chloride 0.9% Bolus) 1,000 mL once IV Bolus, Reason for Infusion = Abnormal fluid losses diphenhydrAMINE (Benadryl) 25 mg = 0.5 mL once IV push methylPREDNISolone (SOLUMedrol) 125 mg = 2 mL once IV push famotidine (Pepcid) 20 mg = 2 mL once IV push EPINEPHrine 0.3 mg = 0.3 mL once intraMUSCULAR
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| 35 | 2021-01-08 | chills, fatigue, headache, nasal congestion, cough | Chills, myalgia, fatigue, headache, nasal congestion, cough |
| 35 | 2021-01-08 | headache, dizziness | Dizziness, headache, feeling faint, nausea, vomiting |
| 35 | 2021-01-08 | influenza like illness, fever, headache |
Headache, Fever & NauseaVomiting Narrative: Received vaccine in morning. By evening experiencing fl...
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Headache, Fever & NauseaVomiting Narrative: Received vaccine in morning. By evening experiencing flu-like symptoms. Missed the next two days of work. Did not seek medical treatment. Managed low fever with tylenol.
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| 35 | 2021-01-08 | chills, fever, headache | Headache, Myalgia, Fever, chills, loss of taste Narrative: |
| 35 | 2021-01-08 | dizziness |
Immediately after immunization, Pt reported feeling "light-headed, strange, having an out of body ex...
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Immediately after immunization, Pt reported feeling "light-headed, strange, having an out of body experience". Increased heart rate (134/m). A&O x 3. Warm, dry. Adult Emergency called and team responded within 2 mins. Pt states symptoms improving rapidly. Transported to ED w/o delay.
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| 35 | 2021-01-08 | body temperature increased, chills, headache | On 1.8.21, woke up with a temp of 101.8 oral, chills, body aches, terrible headache |
| 35 | 2021-01-08 | fever, fatigue |
fatigue the evening of injection lasting 4-5 days, fever Tmax 99.9 starting 72hrs post vaccine last...
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fatigue the evening of injection lasting 4-5 days, fever Tmax 99.9 starting 72hrs post vaccine lasting 24hr, myalgias x 48hrs starting with the fever, mild injection site soreness, managed with ibuprofen
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| 35 | 2021-01-09 | nasopharyngitis, fatigue |
*I have had a very hard time staying warm since the shot the *all of Friday I was nausiouse and tie...
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*I have had a very hard time staying warm since the shot the *all of Friday I was nausiouse and tiered (the day after the shot) * when I woke the next morning my face chin area itched over the past 2 days my face has broken out it itches and is spreading I have tried dubbling my allergy pill taking Benadryl washing my face with Dawn dish soap its 1130am Sunday the 10th jan the rash is all the way up below my upper cheek bones
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| 35 | 2021-01-09 | shortness of breath, dizziness |
25min after injection while driving home, I got a cold sensation in the back of my head, trouble bre...
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25min after injection while driving home, I got a cold sensation in the back of my head, trouble breathing, racing heart, and lightheadedness. pulled over, paramedics called. no treatment, symptoms passed after 30min. (cold sensations, racing heart, and trouble breathing brief, lightheadedness ~30min)
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| 35 | 2021-01-09 | headache |
After the second dose I had headache and body aches. More concerning was a build up of fluid around ...
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After the second dose I had headache and body aches. More concerning was a build up of fluid around my left armpit and left chest.
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| 35 | 2021-01-09 | fatigue, headache | Entire body achy at midnight. Took total of 2 grams Tylenol, HA and tired x24 hrs |
| 35 | 2021-01-09 | fever, migraine, shortness of breath |
Fever tMax 103.9, myalgias, golf ball-sized axillary lymph node, migraine, nausea, shortness of brea...
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Fever tMax 103.9, myalgias, golf ball-sized axillary lymph node, migraine, nausea, shortness of breath.
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| 35 | 2021-01-09 | chills, fatigue, headache, fever |
Fever up to 100.7, chills, myalgias, headache, and fatigue for about 36 hours total after 2nd dose o...
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Fever up to 100.7, chills, myalgias, headache, and fatigue for about 36 hours total after 2nd dose of vaccine
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| 35 | 2021-01-09 | fatigue |
Injection site swelling, redness and pain, started immediately post injection, fatigued that evening...
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Injection site swelling, redness and pain, started immediately post injection, fatigued that evening. Day following vaccine under arm(lymph node area) of injection arm swelling and pain.
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| 35 | 2021-01-09 | runny nose, dizziness | Nauseous, dizzy, sore arm, runny nose for an hour. |
| 35 | 2021-01-09 | fatigue, cold sweat, chills, headache |
On 1/9/21 I slept fitfully, woke up in a cold sweat but had a normal temp of 38.4. I had a headache,...
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On 1/9/21 I slept fitfully, woke up in a cold sweat but had a normal temp of 38.4. I had a headache, body aches, and nausea also. This was approx 16 hours post dose. I took 600mg of ibuprofen and felt more able to do normal home activities but still tired with a sore arm. 4.5 hours post ibuprofen dose I again had muscle aches, headache, fatigue, and nausea. I also had chills and joint pain. I napped for an hour, took another 600mg ibuprofen, and then napped for another 2.5 hours. After that I felt better at 27 hours post dose but still achy and fatigued. These symptoms had mostly resolved by 31 hours post dose.
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| 35 | 2021-01-09 | chills, fever | Severe body aches, joint pain, chills, fever Mild nausea vomiting and abdominal pain |
| 35 | 2021-01-09 | fever, chills, headache |
Severe headache, muscle aches, joint pain, especially prominent in upper back neck, nausea, chills, ...
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Severe headache, muscle aches, joint pain, especially prominent in upper back neck, nausea, chills, feeling hot, fever onset at 0200 1/10/2021 (100.8-100.9), I have taken Tylenol 650mg q 6 hrs. Ibuprofen 800mg once 1/9/21 at 2200.
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| 35 | 2021-01-09 | cough, body temperature increased |
Swelling, redness, moderate itching at injection site Mild numbness, burning, raw feeling with mild ...
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Swelling, redness, moderate itching at injection site Mild numbness, burning, raw feeling with mild feeling of swelling of tongue and lips, coughing, tightness in chest, flushed cheeks, Red rash under left arm pit, temp of 100.4. Body aches.
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| 35 | 2021-01-10 | headache | Brain fog, inability to think clearly, headache |
| 35 | 2021-01-10 | fever, cough, chills |
Cough feeling like bronchitis developed along with fever and chills at approximately 11 hours post d...
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Cough feeling like bronchitis developed along with fever and chills at approximately 11 hours post dose and has persisted with improvement for 72 hours. Covid testing completed on day 3 (due to concern about cough symptoms) was negative.
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| 35 | 2021-01-10 | fatigue, weakness | Feeling of fatigue, full body muscle ache, low energy |
| 35 | 2021-01-10 | headache, chills, fever, fatigue |
I got the shot around 11am on Friday, and felt fine when I went to bed. I woke up around 3am Saturda...
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I got the shot around 11am on Friday, and felt fine when I went to bed. I woke up around 3am Saturday morning with a fever, chills, severe body aches and a headache. The fever went down around 6am, and I took Advil and Tylenol to help get it the rest of the way down and help with the body aches and headache. My symptoms started to resolve around noon, and I was just left feeling severely fatigued.
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| 35 | 2021-01-10 | chills, fever |
I had low grade fever, chills, body aches and joint pains which cause me to barely stand up. These s...
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I had low grade fever, chills, body aches and joint pains which cause me to barely stand up. These symptoms lasted for about 24 hours. Since I'm pregnant I couldn't take any Ibuprofen being pregnant(estimated date of delivery) 3/16/2021.
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| 35 | 2021-01-10 | fever, headache, fatigue, chills, sweating |
I received my second vaccine on Friday 1/8. I felt fine until that evening and then experienced the ...
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I received my second vaccine on Friday 1/8. I felt fine until that evening and then experienced the typical side effects that I had read about. Chills, Severe Headache, All over body, joint, and skin pain. Then developed Fever around 102. Saturday headache was mild, very fatigued, skin felt sunburnt/pain, no fever, was still achy. Temp highest was 99.4 that evening. Noticed palpable clavicular lymph nodes that were very tender. Then noted an axillary one that was about marble sized and tender as well. Sunday about the same- was able to get up and do housework but felt fatigued easily. No temp. Sunday evening developed tenderness in neck area and possible lymph node swelling and decreased ROM. Also at times if I change positions I have a very brief moderate headache. I did wake up in the middle of the night drench with sweat which is very abnormal for me. Neck is the biggest complaint as of now. I called my PCP and they said to call employee health.
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| 35 | 2021-01-10 | fatigue, night sweats, headache, chills, fever |
I received my second vaccine on Friday 1/8. I felt fine until that evening and then experienced the ...
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I received my second vaccine on Friday 1/8. I felt fine until that evening and then experienced the typical side effects that I had read about. Chills, Severe Headache, All over body, joint, and skin pain. Then developed Fever around 102. Saturday headache was mild, very fatigued, skin felt sunburnt/pain, no fever, was still achy. Temp highest was 99.4 that evening. Noticed palpable clavicular lymph nodes that were very tender. Then noted an axillary one that was about marble sized and tender as well. Sunday about the same- was able to get up and do housework but felt fatigued easily. No temp. Sunday evening developed tenderness in neck area and possible lymph node swelling and decreased ROM. Axillary lymph node is larger than a marble currently. Also at times if I change positions I have a very brief moderate headache. I did wake up in the middle of the night drench with sweat which is very abnormal for me. Neck is the biggest complaint as of now. I called my PCP with the above complaints who referred me to employee health.
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| 35 | 2021-01-10 | chills, fever, sweating, headache |
I received the shot around 11am, and around 3am I woke up with a fever, sweating and chills. I was a...
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I received the shot around 11am, and around 3am I woke up with a fever, sweating and chills. I was also experiencing a headache and body aches. My fever went down around 6am, but I was still experiencing severe body aches. The overall affect was similar to the flu. I took some over the counter medications to treat the fever and body aches (Advil and Tylenol) and began feeling better around noon.
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| 35 | 2021-01-10 | fatigue, headache, chills |
I woke up the following morning with a headache but otherwise fine. I took some ibuprofen and receiv...
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I woke up the following morning with a headache but otherwise fine. I took some ibuprofen and received some relief but then began to have nausea and loss of appetite until about 6pm. Beginning around noon I had severe chills without fever and extreme fatigue. These lasted until about 9pm.
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| 35 | 2021-01-10 | malaise, chills, headache, fever | Nausea, vomiting, fever, headache, malaise, muscle pain, chills |
| 35 | 2021-01-10 | fatigue, dizziness, malaise |
Pain and tenderness at injection site following 12 hours post-vaccination. Head fogginess, difficult...
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Pain and tenderness at injection site following 12 hours post-vaccination. Head fogginess, difficulty focusing on tasks, and light-headedness began around 9:00AM on 1/8/2021, and progressively worsened throughout course of day. Severe body aches and joint pain (entire body) with severe malaise and fatigue began later that evening about 8:00PM on 1/8/2021 until about 12:00PM on 1/9/2021. Took Tylenol 500mg as indicated for 24 hours. Symptoms resolved by mid-afternoon 1/9/2021.
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| 35 | 2021-01-10 | headache | Patient had severe nausea, moderate headache all over head while in the observation room. |
| 35 | 2021-01-10 | fatigue, headache, chills, fever |
Swollen lymph nodes; blood pressure was 90/50; Chills; body aches; Fatigue; Joint pain; Bone pain; H...
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Swollen lymph nodes; blood pressure was 90/50; Chills; body aches; Fatigue; Joint pain; Bone pain; Headache; Swelling, pain, redness and soreness at the injection site; Swelling, pain, redness and soreness at the injection site; Swelling, pain, redness and soreness at the injection site; Tachycardia / heart rate was 144-152; painful to breath and she was grunting; also said that the injection site itched a little bit.; Fever; First dose on 17Dec2020, second does on 04Jan2021; This is a spontaneous report from a contactable nurse reporting for herself. A 35-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) ( (lot number was unknown) intramuscularly on 17Dec2020 at 0.3ml, and the second single dose (lot number EJ1685) intramuscularly on 04Jan2021 07:45 at 0.3ml, for COVID-19 prophylaxis. Medical history included ongoing diabetes. Her diabetes was diagnosed about 6 months ago (reported on 06Jan2021) and was well controlled. Her glucose was at 140 at the ER (emergency room) even after drinking a drink that had sugar in it. The patient's concomitant medications were not reported. The patient received the second dose on 04Jan2021 at 07:45 and experienced a severe reaction hours after she received it, and she ended up having to go the ER and that they were baffled about what happened. She reported her symptoms were: fatigue, joint pain mainly in her knees, bone pain that did not feel like muscle pain, headache, swollen lymph nodes in the left axilla, and swelling, redness, pain, and soreness in the left arm at the injection site and also said that the injection site itched a little bit. Her symptoms started about 9-10 at night on 04Jan2021. She said that she felt like with the second dose she noticed the soreness and pain and redness at injection site after about 2 hours after receiving the second dose, which was sooner than with the first injection. The fever started with the chills and body aches. The chills and body aches started at 22:00 on 04Jan2021. She took acetaminophen and melatonin to try and sleep it off. Fever was after that at around midnight 04Jan2021 and she was burning in fever and her temperature was 104. She stated she started taking layers off and got out from under her covers. She had a sweater on when she took her temperature and her axillary temperature was 105. She said that she got into a hot shower because that was the only thing that provided comfort to her chills. She had not had any chills in about the last 12 hours though (as reported on 06Jan2021). She said that the body aches were so severe that she just sat in her bed and cried. She had tachycardia and she was grunting in pain. She was rotating ibuprofen and acetaminophen and then her fever was not as high. She stated that if her fever came back it was lower each time, and if she did not take the medications though, the bone pain was excruciating. She said that with the bone pain it was like no-one can hold her hand or hug her. Fatigue started at around midnight 04Jan2021. Her headache was at midnight. She felt like she had a headband on and was radiating down the back of her neck. She noticed the lymph nodes were swollen after she went to the ER at around 07:00-08:00 05Jan2021. She was walking with pillow under her arm, and if she moved or lifted her arm it hurt. She went to the ER at 01:00 05Jan2021. Her blood pressure was 90/50, her heart rate was 144-152 at rest, temperature was 102.8, O2 saturation was 95-96. She said that it was painful to breath and she was grunting, but did not have any breathing issues. The nurse thought she was septic and notified the doctor. The nurse and the doctor did not think it was the vaccine and thought that she was COVID-19 positive. But after they tested her, she was negative for flu and COVID and they were baffled. They were unclear on what happened and did not think it was from the vaccine. They bolused her 1 liter of Normal Saline and gave her a dose of Fentanyl that minimally helped with the bone pain. She was also given 30mg of ketorolac (TORADOL) IV (intravenous) and that significantly improved her pain. She was there a total of 3 hours. She was admitted to the back area of the ER. She said that they drew labs and everything was within normal limits. Her CRP (C-reactive protein) was 30 and her lactate was at 1.5. She said that they told her that she was most likely having an immune response to the vaccine. Her heart rate and blood pressure came to a more normal range and everything returned to baseline. Her heart rate was 109. She was told to rotate paracetamol (TYLENOL) and ibuprofen for at least the next 24 hours and hydrate. The events fever, chills, fatigue, joint pain, bone pain, headache, swollen lymph nodes, and swelling, pain, redness and soreness at the injection site were serious due to hospitalization from 05Jan2021 to 05Jan2021. The patient was recovering from fever, chills, joint pain, headache, heart rate and blood pressure, not recovered from fatigue, bone pain, swollen lymph nodes and swelling, pain, redness and soreness at the injection site. The event swollen lymph nodes worsened. The outcome of "injection site itched a little bit" was unknown. The reporter considered the events fever, chills, fatigue, joint pain, bone pain, headache, swollen lymph nodes, and swelling, pain, redness and soreness at the injection site were all related to the vaccine; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia, chills, fatigue, pain, arthralgia, bone pain, headache, lymphadenopathy, vaccination site erythema, vaccination site swelling, vaccination site pain, blood pressure decreased, tachycardia, grunting and vaccination site pruritus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 35 | 2021-01-10 | fatigue, headache, fever, chills | chills, muscle pain, joint pain, fever, Headaache, GI upset, fatigue-resolved |
| 35 | 2021-01-10 | chills, fever, headache | fever, body aches, chills, headache. called in sick to work. |
| 35 | 2021-01-10 | fatigue, malaise, fever, chills, headache |
tiredness, headache, muscle pain, chills, joint pain, fever, injection site pain, general feeling un...
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tiredness, headache, muscle pain, chills, joint pain, fever, injection site pain, general feeling unwell
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| 35 | 2021-01-11 | fever, dizziness |
12/21 symptoms were achy light headed, swollen arm, blurred vision, vomiting, fever. Vaccine given ...
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12/21 symptoms were achy light headed, swollen arm, blurred vision, vomiting, fever. Vaccine given 12/18. She was tested for covid 19 on 12/28 and was positive.
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| 35 | 2021-01-11 | dizziness, influenza like illness, thirst, weakness, sweating, dehydration, body temperature increased, discomfort |
After vaccination I felt diaphoretic and dizzy. After waiting in the monitoring area for 45 minutes ...
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After vaccination I felt diaphoretic and dizzy. After waiting in the monitoring area for 45 minutes I drank some water and felt like my bilateral upper thighs were difficult to lift when I tried to walk to my car. I went home and was tachycardic 120-130bpm that continued throughout the night to the point I couldn't sleep my heart was pounding so hard and fast. I was extremely thirsty and dehydrated all night. I continued to have tachycardia for several days despite hydrating. My thighs also continued to feel week for several weeks. I developed a 100.7 F temperature and had flu like symptoms the following days.
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| 35 | 2021-01-11 | throat pain, chills, headache, fatigue |
Approximately 12 hours after vaccine present with vertigo, that lasts for approximately 24-28 hrs. 5...
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Approximately 12 hours after vaccine present with vertigo, that lasts for approximately 24-28 hrs. 5 days after vaccine started presenting with hives, self resolving, migratory. Some other common side effects already known were also present like chills, sore throat, headache, nauseas, tiredness, pain and induration at injection site.
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| 35 | 2021-01-11 | fatigue, chills, headache |
Chills; mild headache; loss of appetite; muscle pain; severe fatigue; This is a spontaneous report f...
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Chills; mild headache; loss of appetite; muscle pain; severe fatigue; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 07Dec2020 15:00 (lot# EH9899), second dose on 04Jan2021 08:00 (lot# EL1284), both intramuscular in left arm at single dose for covid-19 immunization. Medical history reported as none. Allergies to medications, food, or other products: No. There were no concomitant medications. The patient experienced Chills, mild headache, loss of appetite, muscle pain, severe fatigue, all on 04Jan2021 18:00 with outcome of recovering. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. If the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: no. Treatment received for the adverse event: paracetamol (TYLENOL). Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.
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| 35 | 2021-01-11 | chills, fever | Diarrhea, chills, fever |
| 35 | 2021-01-11 | headache, chills, fatigue |
Extreme chills, body aches, nausea, headache, fatigue. Symptoms lasted 24-48hrs after 1st dose, sym...
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Extreme chills, body aches, nausea, headache, fatigue. Symptoms lasted 24-48hrs after 1st dose, symptoms persisting past 4 days on 2nd dose. 2 weeks after 1st dose positive ANA titer was found after an episode of Raynoud?s that had never been experienced previously.
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| 35 | 2021-01-11 | dizziness, headache, fatigue |
Feeling dizzy; head hurt; fatigued; This is a spontaneous report from a contactable other health car...
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Feeling dizzy; head hurt; fatigued; This is a spontaneous report from a contactable other health care professional (patient). A 35-year-old non-pregnant female patient received bnt162b2 (BNT162B2, lot no. and expiry date was unknown), via an unspecified route of administration in left arm on 03Jan2021 14:00 at single dose for Covid-19 immunization. The patient medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced feeling dizzy and her head hurt very bad and so fatigued on 05Jan2021. Since the vaccination, the patient has not been tested for COVID-19. There was no treatment received for the events. The outcome of the events was not recovered. The events were assessed as non-serious. Information about Lot/Batch number is requested.
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| 35 | 2021-01-11 | fever, chills |
Fever of 101, chills, muscle aches, headache about 13 hours after injection. All of those side effec...
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Fever of 101, chills, muscle aches, headache about 13 hours after injection. All of those side effects are gone but I still have a red, itchy hot spot on arm where injection given.
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| 35 | 2021-01-11 | headache, fatigue, malaise |
Headache, tiredness, muscle pain and tingling down the left arm, feeling unwell, feels swollen but d...
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Headache, tiredness, muscle pain and tingling down the left arm, feeling unwell, feels swollen but doesn?t appear to be
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| 35 | 2021-01-11 | influenza like illness | I started developing a rash in my mouth, and flu like symptoms. My lymph node were swollen. |
| 35 | 2021-01-11 | fever, migraine |
Migraine day of vaccine Fever of 101.4 to 102.7 day 2 after vaccine Skin feeling like it?s burning/b...
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Migraine day of vaccine Fever of 101.4 to 102.7 day 2 after vaccine Skin feeling like it?s burning/blistering day 2after vaccine Severe body aches and cramps day 2 after vaccine
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| 35 | 2021-01-11 | migraine, chills, fever, headache |
On day four after the first, 99.5 temp, up to 100.8. Fever, head ache, joint pain. Second vaccinatio...
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On day four after the first, 99.5 temp, up to 100.8. Fever, head ache, joint pain. Second vaccination, fever 102, headache, and joint pain. Chills. Migratory migraine. Second vaccine Jan 8th.
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| 35 | 2021-01-11 | chills, weakness | Weakness, chills, nausea and excruciating stubbing pain in L shoulder with even minor movement |
| 35 | 2021-01-11 | dizziness, nasopharyngitis, chills |
aproximately 5 min after receiving the vaccine, client started c/o light headeness,dizziness, hot fl...
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aproximately 5 min after receiving the vaccine, client started c/o light headeness,dizziness, hot flashes,and a numb lip, cold and shivering. they started o2 at 4liters via nasal canula and gave her 2 Benadryl 25mg oral tabs. At 10:40 she said she felt better, not dizzy, lip not numb, and wasn't feeling cold. She said she would contact her pcp and let him know. She felt good enough to drive off.
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| 35 | 2021-01-11 | sweating, dizziness | broke out in hives, sweaty, pale, complained of dizziness and nausea |
| 35 | 2021-01-11 | dizziness |
collapse/rapid progression of symptoms; hypotension/rapid progression of symptoms; respiratory distr...
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collapse/rapid progression of symptoms; hypotension/rapid progression of symptoms; respiratory distress with stridor; respiratory distress with stridor; dizziness/rapid progression of symptoms; not limited to abdominal pain/rapid progression of symptoms; blood pressure abnormality/rapid progression of symptoms; chest pain/rapid progression of symptoms; drooling/rapid progression of symptoms; increased swelling/rapid progression of symptoms; wheezing; dyspnea and increased work of breathing; skin changes; tongue swelling and vomiting; tongue swelling and vomiting; This is a spontaneous report from a non-contactable other health professional. A 35-year-old female patient (Age at vaccination: 35) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minute waiting period after the injection, the patient began to experience dizziness. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality, chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea and increased work of breathing, skin changes, tongue swelling and vomiting. Treatment included: no therapy. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the collapse, hypotension, respiratory distress and other reported events due to temporal relationship. There is very limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including BP measurements, chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 35 | 2021-01-11 | dizziness, migraine, shortness of breath |
nausea, tingling light headed ness. 24 after injection- Rash started on lower extremities. no itchi...
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nausea, tingling light headed ness. 24 after injection- Rash started on lower extremities. no itching. migraine. nausea, dizziness. positive D Dimer. Shortness of breath Treatment: IV fluids, Reglan. IV Tylenol. Covid test- negative. Na 121.
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| 35 | 2021-01-11 | chills |
severe myalgia 10/10 entire body affected; Hyperesthesia; violent chills/rigors; injection site pain...
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severe myalgia 10/10 entire body affected; Hyperesthesia; violent chills/rigors; injection site pain (worse than prior dose); This is a spontaneous report from a contactable physician (patient herself). A 35-year-old female patient received second dose of PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (left arm) on 05Jan2021 at 11:45 a.m., at a single dose, for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD) and allergic rhinitis. Concomitant medications included loratadine (CLARITIN), methylphenidate hydrochloride (CONCERTA), fluticasone propionate (FLONASE), and montelukast sodium (SINGULAIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 17Dec2020 for COVID-19 immunization and experienced injection site pain; and isoniazid and experienced rash. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 06Jan2021, at 12:00 a.m., the patient experienced severe myalgia 10/10 entire body affected, hyperesthesia, violent chills/rigors, and injection site pain (worse than prior dose), peaked approximately 12 hours after dose. Patient has no fever. It was reported that first dose side effect of moderate 6/10 injection site pain in Dec2020, responded well to naproxen. The patient did not receive treatment for the events. Patient did not seek medical care, because she and her husband are both intensive care unit (ICU) physicians. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination.
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| 35 | 2021-01-12 | headache, respiratory tract congestion, fever, chills |
12 hours after 2nd dose I ran a fever consistently for about 24 hours, had a headache body aches chi...
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12 hours after 2nd dose I ran a fever consistently for about 24 hours, had a headache body aches chills and congestion. After 24 hours of the fever I feel completely normal.
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| 35 | 2021-01-12 | fever, chills, fatigue, headache |
16 hours post vaccine #2 had fever of 102, headache, fatigue, body aches and chills. Ibuprofen 600 m...
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16 hours post vaccine #2 had fever of 102, headache, fatigue, body aches and chills. Ibuprofen 600 mg taken at 20 hours post vaccine. Improvement notified and fever decreased. At 26 hours post vaccine headache notified and fever of 99.6. Tylenol 500 mg taken. Today (1/13) 2 days past vaccine heart rate has been in 100s -110s all day. Headache notified. At 48 hours post vaccine fever developed of 100.5, aches, headache. Tylenol 650mg taken
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| 35 | 2021-01-12 | dizziness |
About 10min after vaccine given, patient c/o dizziness, tingling to lips, no SOB nor difficulty brea...
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About 10min after vaccine given, patient c/o dizziness, tingling to lips, no SOB nor difficulty breathing. VS stable. A rapid response was called but patient monitored. Dizziness resolved.
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| 35 | 2021-01-12 | fatigue, headache, throat pain |
Body aches, fatigue, headache, sore throat, very sensitive skin-felt like a sunburn All but fatigue...
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Body aches, fatigue, headache, sore throat, very sensitive skin-felt like a sunburn All but fatigue resolved after 22 hours
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| 35 | 2021-01-12 | dizziness |
Described feeling woozy/queezy slightly dizzy. Denies nausea & SOB. Started aroumd 5 mintes after sh...
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Described feeling woozy/queezy slightly dizzy. Denies nausea & SOB. Started aroumd 5 mintes after shot, resolved 10 minutes after vitals stable.
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| 35 | 2021-01-12 | chills |
Dose # 1- Disseminated Nonpruritic rash Dose # 2 - chills, myalgia Both- Amenorrhea with negative ...
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Dose # 1- Disseminated Nonpruritic rash Dose # 2 - chills, myalgia Both- Amenorrhea with negative preg tests. This is atypical for me.
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| 35 | 2021-01-12 | fever, fatigue | Fever of 100.4 Fatigue Very sore arm where injection was given |
| 35 | 2021-01-12 | fever, malaise |
Fever, vomitting, nausea. Unable to hold down water, body aches, no appetite, overall feeling awful,...
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Fever, vomitting, nausea. Unable to hold down water, body aches, no appetite, overall feeling awful, pain and swelling at injection site
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| 35 | 2021-01-12 | throat pain, chills, headache, shortness of breath, fatigue |
H/A, sore throat, muscle pain, chills, joint pain, pain at inj. site, nauseated, heart bothering her...
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H/A, sore throat, muscle pain, chills, joint pain, pain at inj. site, nauseated, heart bothering her, feels warm, tired, heat surge, loss of appetite, SOB, Had COVID May 2020.
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| 35 | 2021-01-12 | chills, fever |
I received the 2nd dose of the Pfizer COVID19 on 1/12/21 at approx. 1:30pm. The next day (1/13/21) a...
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I received the 2nd dose of the Pfizer COVID19 on 1/12/21 at approx. 1:30pm. The next day (1/13/21) at approximately 05:30am I awoke feeling feverish with chills and aches. I treated this side effect 400mg ibuprofen Q6HPRN twice during the day and had an Epsom salt bath. The next morning, I was fully recovered.
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| 35 | 2021-01-12 | head discomfort, fatigue, chills, fever |
Patient got fevers to 101, chills, the night of the immunization, that lasted 2 days. 2 days after ...
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Patient got fevers to 101, chills, the night of the immunization, that lasted 2 days. 2 days after the shot, she got hives. She also got bodyaches, which lasted 4 days, headaches, which persistent at day 13, fatigue, which persists at day 13, and head congestion, which persists at day 13. She feels like she had COVID all over again, although she is improving. She is very hesistant to take the second immunization, for fear of what it might do to her. Of note, she had moderately severe COVID starting on July 10, 2020. She was almost hospitalized. She had long hauler's syndrome, and it took her 11 weeks to feel well enough to be able to work full time again.
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| 35 | 2021-01-12 | fatigue, headache | Persistent headache Fatigue Heaviness in lower limbs |
| 35 | 2021-01-12 | fatigue, dizziness |
Pfizer-BioNTech COVID-19 Vaccine on 1/12/2021, patient experienced extreme fatigue and lightheadedne...
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Pfizer-BioNTech COVID-19 Vaccine on 1/12/2021, patient experienced extreme fatigue and lightheadedness after receiving the vaccine. Patient did not go to ED for evaluation.
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| 35 | 2021-01-12 | chills, malaise, headache, fatigue, dizziness |
RECEIVED 2ND DOSE OF PFIZER COVID VACCINE 1/5/21 1600. DURING 15 MIN OBSERVATION COMPLAINED OF FEEL...
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RECEIVED 2ND DOSE OF PFIZER COVID VACCINE 1/5/21 1600. DURING 15 MIN OBSERVATION COMPLAINED OF FEELING DIZZY/LIGHTHEADED. FELT BETTER AFTER EXTENDED OBSERVATION. STATED SHE FLE FINE TO OBSERVER. ON 1/6 WENT TO WORK AND FELT SICK WITH HEADACHE, FATIGUE, FEVER, CHILLS. PATIENT WENT TO ER AND WAS DISCHARGED AFTER 30 MINS
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| 35 | 2021-01-12 | fatigue, respiratory tract congestion, headache, chills |
She developed fevers to 101 that night, and chills, which lasted 2 days. 2 days after immunization,...
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She developed fevers to 101 that night, and chills, which lasted 2 days. 2 days after immunization, she got hives, which resolved. She got body aches, which lasted 4 days, and headaches, fatigue, and head congestion, which are improving, but persist at day 13. Of note, she had COVID on 7/10/2020 and was a long hauler. She was nearly hospitalized. It took her 11 weeks to fully recover.
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| 35 | 2021-01-12 | cough | Slight loose cough. Nonproductive. Slightly sore tonsils. Start 0700am this morning. |
| 35 | 2021-01-12 | fever, malaise, headache |
The patient was a lactating mother; The patient was a lactating mother; Fever 102; Malaise; Headache...
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The patient was a lactating mother; The patient was a lactating mother; Fever 102; Malaise; Headache; Body aches; left axillary pain swelling - lymphedema; left axillary pain swelling - lymphedema; left axillary pain swelling - lymphedema; 1st dose of BNT162B2 on 18Dec2020 13:15/2nd dose on 05Jan2021 13:45; This is a spontaneous report from a contactable other healthcare professional (patient) reported for both mother and baby. This is the maternal report. A 35-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176), via an unspecified route of administration in left arm on 05Jan2021 13:45 at single dose for Covid-19 immunisation. Medical history included hx mild ehler's danlos syndrome, sulfa and latex sensitivity. No covid-prior-vaccination. No covid-tested-post-vaccination. The patient's concomitant medications included Prenatal. The patient previously received 1st dose of BNT162B2 (lot# EK5730) in left arm on 18Dec2020 13:15 for Covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever 102, malaise, severe headache and body aches, left axillary pain swelling - lymphedema on 06Jan2021 12:15. The patient was a lactating mother. The patient underwent lab tests and procedures which included body temperature: 102 on 06Jan2021. The outcome of events was recovering. This case was reported as non-serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021012166 child case
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| 35 | 2021-01-12 | chills, fatigue | The symptoms was chills, body aches, very tired and no fever.(estimated date of delivery 5/17/2021) |
| 35 | 2021-01-12 | fatigue | Very bad body aches and fatigue that lasted 48 hours |
| 35 | 2021-01-12 | shortness of breath, throat pain, nasal congestion, headache |
arm sore, sore throat,nasal congestion, chest hurt when taking deep breath,sob ,headache, pulse 100,...
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arm sore, sore throat,nasal congestion, chest hurt when taking deep breath,sob ,headache, pulse 100, advised to see PCP
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| 35 | 2021-01-12 | fatigue, chills, headache, throat pain |
h/a, sore throat, muscle pain, chills, joint pain, pain at inj. site, nauseated, feels warm, tired, ...
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h/a, sore throat, muscle pain, chills, joint pain, pain at inj. site, nauseated, feels warm, tired, warm surges.
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| 35 | 2021-01-13 | malaise, headache, sweating, fever |
12 hrs after first and second vaccines: injection site pain, fever 100F, sweating, body aches, joint...
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12 hrs after first and second vaccines: injection site pain, fever 100F, sweating, body aches, joint pain, headache, malaise. First vaccine side effects lasted 1-2 days. Just had second vaccine yesterday, symptoms have not resolved yet
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| 35 | 2021-01-13 | migraine |
About 11:30 while at working all of the sudden my peripheral vision became black, my bp raised to ...
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About 11:30 while at working all of the sudden my peripheral vision became black, my bp raised to 180/120 and I was sent to the ER (Hospital) for monitoring. After some time it leveled out and I was released home to rest. That night and the next day I had a migrane, felt sluggish and really couldnt do anything. I took tylenol and motrin to help with the pain.
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| 35 | 2021-01-13 | fatigue, dizziness, cold sweat, headache |
Approximately 10 minutes after receiving the vaccine the patient became clammy and light headed. VS ...
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Approximately 10 minutes after receiving the vaccine the patient became clammy and light headed. VS were stable and patient stayed an extra 30 minutes until she started feeling better. With follow up call, patient stated that she has headache, nausea and fatigue
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| 35 | 2021-01-13 | dizziness, head discomfort, fatigue, fever, sweating, headache |
Associate reports Fever, headache, and sweating that began on 1/13/21, and fatigue, dizziness, "heav...
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Associate reports Fever, headache, and sweating that began on 1/13/21, and fatigue, dizziness, "heavy head", tachycardia, and hypertension starting on 1/14/21. Advised to seek medical treatment.
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| 35 | 2021-01-13 | fever, chills, weakness |
Chills; low-grade fever (100.9 at highest); muscle aches; weakness; diarrhea; This is a spontaneous ...
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Chills; low-grade fever (100.9 at highest); muscle aches; weakness; diarrhea; This is a spontaneous report from a contactable other Health Care Professional (HCP). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number and expiration date unknown), intramuscularly, on 05Jan2021 (at the age of 35-years old) at an unspecified dose in the left arm for COVID-19 vaccination. Medical history included Thalassaemia from an unknown date and COVID-19 on an unknown date. The patient's historical vaccines included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730) on 17Dec2020 (at the age of 35-years-old) at unspecified dose in the left arm for COVID vaccination.The patient has no allergies to medications, food, or other products. The patient was administered the vaccine in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient had been diagnosed with COVID-19 on an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccinations. On 05Jan2021 at 23:30 the patient experienced chills, low-grade fever (100.9), muscle aches, weakness and diarrhea. The patient did not receive any treatment for the events. The clinical outcome of the events was reported as recovered on an unspecified date in Jan2021. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 35 | 2021-01-13 | shortness of breath, migraine, fatigue, somnolence, head discomfort |
Fatigued about 8 pm last night Woke up groggy 10 am - migraine started 11 am - shortness of breath...
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Fatigued about 8 pm last night Woke up groggy 10 am - migraine started 11 am - shortness of breath and fatigued (out of it really bad) Noon - heaviness in the chest 12:45 (current time) Aches in my shoulders, Migraine in my right temple area, short of breath, chest burning, head feels heavy to my neck. Similar symptoms to when I had Covid in the end of October.
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| 35 | 2021-01-13 | headache, dizziness | Nausea Vomiting Diarrhea Headache Dizziness (4 days) |
| 35 | 2021-01-13 | dizziness |
Previous report filed 12/23. On 12/25 I woke up with rash on face, neck, arms, and chest. Itchy. Too...
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Previous report filed 12/23. On 12/25 I woke up with rash on face, neck, arms, and chest. Itchy. Took Benadryl. Went away. On 12/27 I have another bout of palpitations that lasted 30 mins with heart rate at 130s at rest with dizziness and lightheaded ness.
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| 35 | 2021-01-13 | headache, chills, fatigue |
Progressively worsening chills, myalgias, headache, fatigue peaking at 24 hours post vaccine. All mi...
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Progressively worsening chills, myalgias, headache, fatigue peaking at 24 hours post vaccine. All mild. Did not need medication.
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| 35 | 2021-01-13 | shortness of breath, headache, migraine, fever, chills |
Shortness of breathe; Rapid heart rate; migraines; Fever; Chills; Body aches; Muscle tightness; Head...
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Shortness of breathe; Rapid heart rate; migraines; Fever; Chills; Body aches; Muscle tightness; Headaches; This is a spontaneous report from a contactable Other Health Professional (patient). A 35 years old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose (lot EK5230) via Intramuscular on 16Dec2020 11:30 in the left arm at single dose, second dose via Intramuscular on 06Jan2021 11:00 in the left arm at single dose for COVID-19 prophylaxis. Medical history and concomitant medications were none. Caller did not experience any side effects after the first dose. After the second dose, caller experienced, fever, chills, body aches, muscle tightness and headache. Today the caller also experienced shortness of breathe and a rapid heart rate. Fever; She said that she noticed her fever at 0130 07Jan2021. He fever started at 100.3 at 0130 and at 0400 it was 100.8. She took it at 1000 and it was 101. She has not taken her temperature since. Chills: She woke her up at 0130 07Jan2021 she said that she sleeps with a electric heated blanket and she woke up cold. Body aches: She noticed that she had the body aches and pain at 0130 07Jan2021. She said that she has not been able to sleep because the pain has been so bad. Muscle tightness: She said that it hurts to stand up and walk. She stated that she had to get a Covid test this morning so she had to move. She noticed the muscle tightness at 0130 07Jan2021 along with the body aches. Headaches: caller said that she noticed her headache around 0130 07Jan2021. She said that it is a dull achy headache. She stated that she get migraines and thought it was because of her fever. Shortness Of Breath: She said that she noticed she was short of breath around 1230 07Jan2021. She stated that it is hard to breath right now and feels like someone is standing on her chest. Rapid heart rate: Her watch at 1230 07Jan2021 said that she had a 116 heart rate and that was at rest. Outcome of event Chills was recovering, while outcome of other events was not recovered.
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| 35 | 2021-01-13 | shortness of breath, headache, throat pain, dizziness |
Sore throat, severe chest tightness and pressure, very hard to breathe in, more than 30 minutes afte...
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Sore throat, severe chest tightness and pressure, very hard to breathe in, more than 30 minutes after covid vaccine, dizziness, headache, lightheadedness; severe chest tightness and pressure; very hard to breathe in, more than 30 minutes after covid vaccine; Dizziness /lightheadedness; headache; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration at left arm on 09Jan2021 10:30 at single dose for COVID-19 immunization at a hospital. The patient's medical history included migraines, asthma, diabetes, sleep apnea, low immune system, post-traumatic stress disorder (PTSD), depression, panic attacks, insomnia, borderline personality disorder, and known allergies to medications, food, or other product (10 total). Concomitant medications included adult tetanus vaccine on 04Jan2021 received at right arm, for immunization (within 4 weeks prior to the COVID vaccine); first dose of botulinum toxin type a (BOTOX) on 06Jan2021 at single (31 shots in 7 muscle groups) for migraines (within 4 weeks prior to the COVID vaccine); and clindamycin antibiotic for infection in finger (took within in two weeks). The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. On 09Jan2021 11:00, the patient experienced sore throat, severe chest tightness and pressure, very hard to breathe in, more than 30 minutes after COVID vaccine, "dizziness/lightheadedness", and headache. The above mentioned events resulted in emergency room/department or urgent care visit, and patient received breathing treatment, oxygen for over an hour for these events. The outcome of the events was unknown. The reporter considered the events as non-serious.
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| 35 | 2021-01-13 | body temperature increased, headache, chills |
The evening I got the shot I felt my muscles starting to ache. The next morning when I woke up I wa...
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The evening I got the shot I felt my muscles starting to ache. The next morning when I woke up I was achy, but still went to work. Around 11:00 am on 1/13/21 I started to feel flushed and the chills. Took my temp and it was 100.3 F. I was achy all over and had a headache too.
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| 35 | 2021-01-13 | headache |
Very intense headache and general body ache, I took acetaminophen and naproxen and nothing would tak...
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Very intense headache and general body ache, I took acetaminophen and naproxen and nothing would take the pain away.; Very intense headache and general body ache, I took acetaminophen and naproxen and nothing would take the pain away.; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received bnt162b2 (lot:EK9231), via an unspecified route of administration in the left arm on 05Jan2021,16:30 at a single dose for covid-19 immunization. The patient's medical history included depression and migraines and covid-19 all from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medication included escitalopram (ESCITALOPRAM). On 05Jan2021 at 18:00, the patient experienced very intense headache and general body ache. Patient took acetaminophen and naproxen and nothing would take the pain away. Therapeutic measures were taken as a result of very intense headache and general body ache included acetaminophen and naproxen sodium but nothing would take the pain away. The outcome of the events was recovered on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination.
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| 35 | 2021-01-13 | migraine, shortness of breath, fatigue |
Woke up with a very sore arm. About 10 am Migraine started 11 am Tired "feeling out of it" Noon -...
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Woke up with a very sore arm. About 10 am Migraine started 11 am Tired "feeling out of it" Noon - Short of breath Currently 12:30 Muscle soreness in shoulders, migraine worse, heavy chest
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| 35 | 2021-01-13 | fever, chills |
fever off and on/ temperature was 100.4; Chills; severe body aches; This is a spontaneous report fro...
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fever off and on/ temperature was 100.4; Chills; severe body aches; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 16Dec2020 at 0.3 mL, single; then the second dose on the left arm (reported as 'left shoulder') to 05Jan2021 at 0.3 mL, single for COVID-19 immunization. Medical history included Raynaud's disease probably diagnosed like 7 years ago, but she was not taking anything for it. There were no concomitant medications. The patient reported that she was a dietician. She works in the ICU at the hospital, but was not a healthcare professional. She just got the second dose on Tuesday (05Jan2021), and had severe body aches, fever on and off, and chills with the body aches. Severe body aches started Tuesday evening, but were not really bad, she was just achy, then around midnight on Tuesday, they became severe and she had a fever. They resolved kind of this morning, right now she is a little achy, not like before, where her full body was hurting, it hurt to lay down or do anything, she had to lay in bed for 24 hours. Fever started at midnight, so she guess on 06Jan2020, now she doesn't feel feverish, but she didn't check, she thinks it broke again last night, she was taking Advil. She took acetaminophen (TYLENOL) the first night, at midnight, when she got the fever, she took acetaminophen, and tried to go back to sleep, and woke up at 6AM, with severe body aches still, and her temperature was 100.4 so she took ibuprofen (ADVIL). Acetaminophen for some reason bothers her stomach, so she took ibuprofen. She felt like the acetaminophen didn't do anything. She came to work today. After that, she was taking ibuprofen yesterday through the day. The chills were along with the fever and body aches and are not ongoing right now. She had symptoms after the first round of the Pfizer COVID vaccine too, but they were not as bad. The outcome of the event severe body aches was recovering, of chills was recovered on an unspecified date, and of fever was unknown.
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| 35 | 2021-01-13 | dizziness, headache, fever, fatigue |
headaches for rest of day; severe dizziness; chest palpitations; extreme muscle weakness; projectile...
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headaches for rest of day; severe dizziness; chest palpitations; extreme muscle weakness; projectile vomiting- all x15 minutes; fever of 101.1; general fatigue; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176), intramuscular on 06Jan2021 14:30 at single dose at left arm for covid-19 immunization. Medical history included anxiety, osteoarthritis from an unknown date and unknown if ongoing. No known allergies to medications, food, or other products. Concomitant medications in two weeks included escitalopram oxalate (LEXAPRO), paracetamol (TYLENOL), ibuprofen. Patient previously received first dose of bnt162b2 (Batch/lot number: EH9899) intramuscular on 16Dec2020 14:45 at single dose at right arm for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. The patient experienced severe dizziness, chest palpitations, extreme muscle weakness, projectile vomiting- all x15 minutes, followed by fever of 101.1 after paracetamol, general fatigue, headaches for rest of day from 07Jan2021 08:30 am with outcome of recovering. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report is considered as non-serious.
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| 35 | 2021-01-14 | fever, fatigue, headache |
1/6/21 I had fatigue, fever up to 101F, chills, headache, injection site pain, and joint pain that a...
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1/6/21 I had fatigue, fever up to 101F, chills, headache, injection site pain, and joint pain that all resolved by the time I woke up the next day. However, on 1/7/21 and 1/8/21 I had pain in my right axilla that I attribute to lymphadenopathy. I did not treat any symptoms and they resolved on their own.
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| 35 | 2021-01-14 | sweating, fever, headache, chills |
12 hours post vaccine developed severe muscle and bone pain and a fever, took 1000 mg of Tylenol 17 ...
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12 hours post vaccine developed severe muscle and bone pain and a fever, took 1000 mg of Tylenol 17 hours post vaccine and the fever broke, but the pain persisted. Took Ibuprofen 20 hours post vaccine because I developed a severe headache in addition to nausea. Headache became less intense, but all other symptoms remained at the same intensity. I fell asleep and woke up with a 103F at 28 hours. Pain persisted as well. I went back to sleep and woke up at 7pm when the fever broke, I noticed all the other symptoms were gone except for some new neck pain. The neck pain could be related to how I slept though since it was new. I did not take any more medication and went back to bed later in the evening. I woke up at 4am, roughly 29 hours post vaccine, with a fever and didn't take my temperature, but did take 1000 mg Tylenol. It broke an hour later. I have had waves of symptoms of a low grade fever all day (slight chills), which then feels like it breaks on its own indicated by sweat and chills disappearing. I haven't had to medicate any further however and in comparison to yesterday I feel amazing!
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| 35 | 2021-01-14 | headache |
1st vaccine- mild headache and mild arm soreness; 1st vaccine- mild headache and mild arm soreness; ...
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1st vaccine- mild headache and mild arm soreness; 1st vaccine- mild headache and mild arm soreness; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via unknown route of administration, on 18Dec2020 (at the age of 35 years old) as a single dose in the right arm via unknown route of administration for COVID-19 immunization at hospital facility. Relevant medical history was unknown. It was unknown if patient has any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unknown date, after the first dose, the patient experienced mild headache and mild arm soreness. No treatment was received for the events mild headache and mild arm soreness. The outcome of the events mild headache and mild arm soreness was unknown. The patient was not pregnant at time of vaccination. Since the vaccination, the patient had not been tested for COVID-19.
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| 35 | 2021-01-14 | headache, chills, fever |
Body aches; fever; chills; headache; This is a spontaneous report from a contactable other health pr...
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Body aches; fever; chills; headache; This is a spontaneous report from a contactable other health professional (patient). A 35-year-old female patient (no pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: El1283) via an unspecified route of administration on the left arm on 08Jan2021 02:00 PM at single dose for COVID-19 immunisation. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ek5730) via an unspecified route of administration on the left arm on 18Dec2020 03:45 PM at single dose for COVID-19 immunisation. Medical history included known allergy to Bactrum and ciprofloxacin hydrochloride monohydrate (CIPRO). The patient's concomitant medications included bupropion hydrochloride (WELLBUTRIN) and lisdexamfetamine mesilate (VYVANSE). No other vaccine in four weeks. On 09Jan2021 at 04:00 AM, patient experienced body aches, fever, chills, headache. Nasal swab covid test post vaccination on 28Dec2020 was negative. No treatment received for the events. The outcome of events was unknown.
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| 35 | 2021-01-14 | headache, fever |
Chills, fever, headache, nausea, diarrhea, myalgia, palpitations (same side effects were present aft...
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Chills, fever, headache, nausea, diarrhea, myalgia, palpitations (same side effects were present after the first dose (12/22) except for diarrhea, a rash developed one week after the first vaccine)
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| 35 | 2021-01-14 | chills |
Chills, myalgia, axillary lymphadenopathy; Chills, myalgia, axillary lymphadenopathy; Chills, myalgi...
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Chills, myalgia, axillary lymphadenopathy; Chills, myalgia, axillary lymphadenopathy; Chills, myalgia, axillary lymphadenopathy; This is a spontaneous report from a contactable other HCP. A 35-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (anatomical location: arm right) from 09Jan2021 to 09Jan2021 at single dose for COVID-19 immunisation. Medical history was reported as none. The patient had first vaccine on 18Dec2020 to 18Dec2020 for COVID-19 immunisation. The patient's concomitant medications were not reported. On 09Jan2021, the patient experienced chills, myalgia, axillary lymphadenopathy. The patient did not received any treatment for the events. Outcome of the events was recovering.
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| 35 | 2021-01-14 | fever |
Complaints of fever, tachycardia after vaccination,myalgias, chest ache, axillary adenopathy and ten...
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Complaints of fever, tachycardia after vaccination,myalgias, chest ache, axillary adenopathy and tenderness.
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| 35 | 2021-01-14 | fatigue, cough, runny nose, fever | FEVER (101.1), RUNNY NOSE, COUGH, ACHY, AND TIRED |
| 35 | 2021-01-14 | fatigue, headache, fever, chills |
Fatigue, myalgia, fever, chills, headache lasting at least several hours. I am still experiencing th...
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Fatigue, myalgia, fever, chills, headache lasting at least several hours. I am still experiencing them and it has been 5 hours. Minimal improvement with Tylenol.
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| 35 | 2021-01-14 | throat pain, shortness of breath, throat irritation |
From prescriber progress note: "The patient is a 35-year-old the presents emergency department with ...
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From prescriber progress note: "The patient is a 35-year-old the presents emergency department with sudden onset of scratchy pain in the throat that is worse with swallowing and numbness and tingling in the lips and tongue with difficulty breathing without cough that all started suddenly less than 20 minutes after receiving her 2nd COVID-19 vaccination. Patient states that since then pain is worse with swallowing and difficulty breathing is becoming worse. She denies any fever or chills. She states she does feel short of breath. She states she has not taken medication for this as of yet. Patient is hospital employee and was at hospital COVID clinic."
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| 35 | 2021-01-14 | headache |
Headache, muscle ache in evening for few hours. Nausea And vomiting in the morning. Vomited 3-4 time...
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Headache, muscle ache in evening for few hours. Nausea And vomiting in the morning. Vomited 3-4 times in morning, then sore stomach rest of day( persistent after 14 hrs.). Able to eat light meals throughout day.
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| 35 | 2021-01-14 | weakness, fever, throat pain |
Heart palpitations Weakness Sore throat Low grade fever Lymph node swelling Arms soreness Inje...
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Heart palpitations Weakness Sore throat Low grade fever Lymph node swelling Arms soreness Injection site redness and swelling
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| 35 | 2021-01-14 | headache, shortness of breath |
Initially headache and body aches. Within 24 hours developed chest pain, dyspnea on exertion and sho...
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Initially headache and body aches. Within 24 hours developed chest pain, dyspnea on exertion and shortness of breath. Patient still currently hospitalized.
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| 35 | 2021-01-14 | fever |
Joint pain; Low grade fever; Nausea; Redness at injection site; Pain at injection site; Warmth at in...
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Joint pain; Low grade fever; Nausea; Redness at injection site; Pain at injection site; Warmth at injection site; Mild swelling in distal hand of injection; Moldy swollen axillary lymph nodes; received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021; received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021; This is a spontaneous report from a contactable Nurse(patient). A 35-year-old female patient received second dose BNT162B2(lot number EJ1685) , via an unspecified route of administration at Arm Right on 07Jan2021 16:00 at the 35 years old at single dose for COVID-19 immunization. The medical history included PCOS, depression. The patient was not Allergies to medications, food, or other products. The concomitant medications were bupropion and venlafaxine. The patient previously took first dose BNT162B2 (lot number EK5730) on 21Dec2020 at 35 years old at Left arm for COVID-19 immunization. On 08Jan2021 08:00 the patient experienced Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes. There was no treatment received for the adverse events Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events Joint pain, low grade fever, nausea, redness at injection site, pain at injection site, warmth at injection site, mild swelling in distal hand of injection, moldy swollen axillary lymph nodes was not recovered. The information on the batch number has been requested.
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| 35 | 2021-01-14 | headache, respiratory tract congestion | Nausea, headache and congestion |
| 35 | 2021-01-14 | chills, headache, fatigue |
Pain at injection site; Headache; Nausea; Vomiting; Loss of appetite; Fatigue; Chills; This is a spo...
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Pain at injection site; Headache; Nausea; Vomiting; Loss of appetite; Fatigue; Chills; This is a spontaneous report from a non-contactable nurse (patient herself). This 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3248), via intramuscular, on 09Jan2021 at 10:30, at single dose in the left arm, for COVID-19 immunisation. The patient was not pregnant. She was vaccinated at hospital, age at vaccination was 35-year-old. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL5730), via intramuscular, on 19Dec2020 at 13:00 at single dose in the right arm. Historical vaccine includes Hepatitis A vaccine (single dose, via an unknown route in the arm left) on 18Dec2020. No medical history was provided. No known allergies. No relevant concomitant medications were provided. The patient was vaccinated at hospital, age at vaccination was 35-year-old. Pre-vaccination and post-vaccination COVID tests were not performed. On 09Jan2021 at 18:00, the patient developed pain at injection site, headache, nausea, vomiting, loss of appetite, fatigue, and chills. The patient was not treated for the events. The patient had recovered from the events on unknown date in Jan2021. No follow-up attempts are possible. No further information expected.
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| 35 | 2021-01-14 | dizziness |
Patient reports that she received her second vaccination for COVID 19 (Pfizer) and was feeling well ...
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Patient reports that she received her second vaccination for COVID 19 (Pfizer) and was feeling well initially but after 10-15 minutes stood up and got acutely dizzy. Denies any associated pain, nausea, palpitations, sob. Feels perfectly well at time of my evaluation: all symptoms resolved and patient is requesting to be discharged to go to work.
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| 35 | 2021-01-14 | fatigue, dizziness, headache, somnolence, cough |
Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous re...
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Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program, from a contactable nurse (patient). A 35-year-old female patient (weight 55.79 kg, height 160 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK5730) intramuscularly, in the left deltoid, at single dose, on 23Dec2020 at 12:30, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history and concomitant medications were none. On 25Dec2020, the patient felt extremely tired (fatigue). On 28Dec2020, the patient had headache and minor cough noticed. On 29Dec2020, the patient experienced back pain and she said that it felt like sunburn soreness more than anything else. She said that she literally slept 3 days in a row (29Dec2020, 30Dec2020, and 31Dec2020). On 31Dec2020, the patient lost her sense of smell and developed dizziness. On 01Jan2021, the patient experienced nausea and lost her sense of taste. COVID-19 virus test was found positive on 01Jan2021.The patient recovered from back pain, sunburn and sleepy on 31Dec2020, recovered from tiredness on 01Jan2021, recovered from nausea and dizziness on 06Jan2021. Clinical outcome of the events, smell loss, cough, headache, and loss of taste was recovering. Final clinical outcome of positive COVID-19 test with symptoms was unknown at time of this report. The case was assessed as serious (medically significant). She is scheduled to get 2nd dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 13Jan2021 and is wanting to know if she is supposed to get it.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.
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| 35 | 2021-01-14 | malaise, headache |
STARTING TO NOT FEEL WELL AFTER WALKING OUT OF THE BUILDING WITH A UPSET STOMACH, THEN THROUGH OUT T...
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STARTING TO NOT FEEL WELL AFTER WALKING OUT OF THE BUILDING WITH A UPSET STOMACH, THEN THROUGH OUT THE DAY I STARTED TO GET A HEADACHE AND MY ARM WAS STARTING TO HURT ALSO, THE NEXT DAY I WOKE UP WITH MY BODY HURTING AND FEELING SICK TO MY STOMACH. IT TOOK ANOTHER DAY FOR ME TO FEEL BACK TO MYSELF.
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| 35 | 2021-01-14 | headache, chills, fatigue |
Sore arm, body aches, chills, headache. By 48 hours most of the symptoms had faded to very minor. Ex...
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Sore arm, body aches, chills, headache. By 48 hours most of the symptoms had faded to very minor. Exhausted within hours of the shot.
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| 35 | 2021-01-14 | lethargy, nasal congestion, throat pain |
Sore throat; congested; 2nd dose - lethargic for 24 hours.; intense muscle and joint pain for about ...
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Sore throat; congested; 2nd dose - lethargic for 24 hours.; intense muscle and joint pain for about 48 hours from proximal kneels to neck (hurt to move, shoulder flexibility pain free range 0-30 degrees, couldn't lay on right arm).; intense muscle and joint pain for about 48 hours from proximal kneels to neck (hurt to move, shoulder flexibility pain free range 0-30 degrees, couldn't lay on right arm).; first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020/ second dose of BNT162B2 on 06Jan2021; first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020/ second dose of BNT162B2 on 06Jan2021; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231, expiration date 30Apr2021), via an unspecified route of administration on right arm at 08:30 AM on 06Jan2021 at single dose for COVID-19 immunization. Medical history included hypothyroid. Concomitant medication included levothyroxine, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), colecalciferol (VITAMIN D) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 at single dose for COVID-19 immunization and experienced minimal pain right deltoid area. For the second dose, the patient experienced lethargic for 24 hours, intense muscle and joint pain for about 48 hours from proximal kneels to neck (hurt to move, shoulder flexibility pain free range 0-30 degrees, couldn't lay on right arm). Took Tylenol to decrease muscle and joint pain, which helped. Day 4 post vaccine on 10Jan2021, slight sore throat, congested, but muscle and joint pain generally resolved. It was only day 4. The outcome of events muscle pain and joint pain was recovered on 10Jan2021, the outcome of reset events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the had not patient been tested for COVID-19.
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| 35 | 2021-01-14 | dizziness, shortness of breath |
This is a spontaneous report from a contactable Physician. A 35-years-old female patient received bn...
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This is a spontaneous report from a contactable Physician. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at the first single dose for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. Immediately after receiving the first dose of the vaccine, the patient reported having dizziness and tingling throughout her body, she could not feel her hands, the patient was not anxious. After that, her heart began to pound and it was difficult for her to breathe, after a minute she felt her heartbeat begin to normalize. After 30 minutes she began to normalize, but she went to the emergency room and began to feel nausea, her body hurt and her heart rate was 140 bpm, the episode lasted 30 seconds. The outcome of events was unknown. Information on the Batch/Lot number has been requested.
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| 35 | 2021-01-14 | fever, chills |
red hives; chills; body aches; low fever; This is a spontaneous report from a contactable other heal...
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red hives; chills; body aches; low fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via an unspecified route of administration on Left arm from 08Jan2021 12:45 to 08Jan2021 12:45 as SINGLE DOSE for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. On 08Jan2021 at 18:45 (6 hours after receiving vaccine), the patient broke out in red hives, experienced chills, body aches and low fever. The outcome of the events was recovered. No treatment was given for the events. Since the vaccination, the patient has not been tested for COVID-19.
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| 35 | 2021-01-14 | cold sweat, fever |
vaccinated 01/13/2021, at 0830. Her co-worker called down this afternoon and reported that sometime...
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vaccinated 01/13/2021, at 0830. Her co-worker called down this afternoon and reported that sometime between 11:30 am and noon, Patient started having cold sweats, nausea, low grade temp, and body aches. She did vomit once, but had just eaten lunch.
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| 35 | 2021-01-15 | weakness, fever |
Developed fever Sunday night into Monday along with severe body aches, joints pain and weakness. too...
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Developed fever Sunday night into Monday along with severe body aches, joints pain and weakness. took Tylenol 500mg every 6 hours. on Tuesday symptoms continued. Wednesday felt little better with no fever but body ache and joint pain continued. Was out from work for 3 days. Weakness and joint pain is still there (today is Saturday). will continue to monitor
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| 35 | 2021-01-15 | fatigue |
I was 5 weeks pregnant when I got my first dose of the Pfizer covid-19 vaccine. I miscarried 4 days...
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I was 5 weeks pregnant when I got my first dose of the Pfizer covid-19 vaccine. I miscarried 4 days later. I do not know if the vaccine contributed to my miscarriage but wanted to contribute to the existing data. I had no other side effects or symptoms other than soreness at the injection site. There were no complications with the miscarriage.
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| 35 | 2021-01-15 | throat pain, throat irritation |
Itchiness in throat, feeling of a lump in my throat, tingling in throat and tongue. Very mild, no i...
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Itchiness in throat, feeling of a lump in my throat, tingling in throat and tongue. Very mild, no inability to breathe. Mild discomfort only. Benadryl seemed to keep reaction from getting worse. Sensation persisted for several hours and was gone the next day other than the slight feeling of a sore throat.
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| 35 | 2021-01-15 | dizziness |
That morning I had taken amlodipine for the 2nd time in my life to help Raynaud's. Both times I hav...
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That morning I had taken amlodipine for the 2nd time in my life to help Raynaud's. Both times I have taken amlodipine now I have felt lightheaded and less cognitively sharp than normal basically the entire day. I received the above Pfizer COVID-19 vaccine around 12:45 PM, within about 3-5 minutes of receiving the vaccine and standing in line to check out I suddenly felt I was going to loss consciousness/collapse so started lowering myself to the ground and then became unconscious and fell. Healthcare staff informed me I was unconscious for about 20-30 seconds. I woke up and initially felt confused, but quickly realized what had happened. Then I felt nauseated, had some stomach cramps and thought I was going to have diarrhea. They considered giving me Epi for possible anaphylaxis, but I requested they observe further for any skin reaction/hives, airway symptoms, etc given I was skeptical the syncope may have been fully or partially related to the amlodipine I took that morning. Symptoms slowly improved over 20-30 minutes, but the lightheaded feeling and nauseated lasted hours. No Epipen, medications, or interventions were needed.
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| 35 | 2021-01-17 | body temperature increased, fatigue, shortness of breath |
Couple hours after the vaccine, experienced elevated temperature, difficulty taking full deep breath...
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Couple hours after the vaccine, experienced elevated temperature, difficulty taking full deep breathes (attributed to fatigue). Temperature improved but fatigue and shortness of breathe continued until 1/16/21. a bilater arm rash occurred and employee went to the Emergency Department for an assessment. At this time, she was having chest tightness, shortness of breathe. Lab - troponins elevated. Other labs - within normal limits. Admitted to hospital for observation and discharged next day. Today, during cardiac follow-up appt, was having decreased oxygen saturation levels, increased pulse rate. Admitted again today for obsevation with cncern of acute endocarditis.
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| 35 | 2021-01-17 | nasal congestion, chills, shortness of breath, fatigue, headache, influenza like illness |
Extreme fatigue; Uncontrollable chills for 3 hours; Flu like symptoms; Generalized muscle soreness; ...
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Extreme fatigue; Uncontrollable chills for 3 hours; Flu like symptoms; Generalized muscle soreness; Stuffy nose and ears; Stuffy nose and ears; Short of breath; Loss of appetite; Headache; Headache; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 08Jan2021 07:15 at right arm, at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 28Dec2020 at right arm, at single dose for covid-19 immunization, and experienced mild headache and mild arm soreness. The patient received the second dose, and experienced extreme fatigue, uncontrollable chills for 3 hours, flu-like symptoms (headache, generalized muscle soreness, stuffy nose and ears), short of breath, loss of appetite, all at 08Jan2021 13:00. The outcome of the events was recovering. No treatment was received for all events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
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| 35 | 2021-01-17 | dizziness, shortness of breath, headache |
Palpitations with heart rate up to 150 on 1/10/21 at 2pm accompanied by dizziness, nausea, headache ...
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Palpitations with heart rate up to 150 on 1/10/21 at 2pm accompanied by dizziness, nausea, headache and shortness of breath. Required IV fluids, EKG, labs, telehealth visit, cardiology referral and placed on Metoprolol for suspected POTS. Currently still having orthostatic tachycardia 7 days after onset of symptoms and pending cardiology referral.
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| 35 | 2021-01-19 | headache |
1)arm soreness that lasted for a couple of days 2)bad headache that started 2 days after the vaccine...
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1)arm soreness that lasted for a couple of days 2)bad headache that started 2 days after the vaccine and require Motrin
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| 35 | 2021-01-19 | fatigue, dizziness, chills, somnolence, shortness of breath, headache |
Around 30 minutes after vaccine, I started to feel dizzy and light headed As the day went on, I sta...
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Around 30 minutes after vaccine, I started to feel dizzy and light headed As the day went on, I started to get a headache and get very tired. Then around 5 I started to feel intense: Headache Chills/cold Dizzy/light headed/almost fell over several times Muscle weakness, could not carry anything or lift Muscles in face felt like they were melting down/stroke sensation Exhaustion Sore/achy everywhere Tender left arm where shot was Could not think/memory was gone/could not put together a sentence Tightness chest/hard to breath Could not keep eyes open Had to lay down and sleep with long pants long sweater, jacket and 3 blankets I woke up the next morning and some of my symptoms were gone except I still felt tired and had some achy ness, pain and left arm hurt and had shooting pain in joints Shooting severe pain in each joint, laster for 3 days, most severe in joints where I received vaccine but also in wrists, shoulder, elbows, hips, knees, ankles At day 5 my left arm is still sore including muscles around injection site
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| 35 | 2021-01-19 | fatigue, headache |
Day one, diarrhea, sore arm, headache, fatigue . Day 2 sore arm, fatigue day 3 fatigue day 4 headac...
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Day one, diarrhea, sore arm, headache, fatigue . Day 2 sore arm, fatigue day 3 fatigue day 4 headache day 5 headache day 6 swollen neck lymph nodes as well as armpits and body aches
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| 35 | 2021-01-19 | throat swelling |
Described tongue tingling/numbness approximately 30 minutes after receiving the vaccine. Evaluated i...
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Described tongue tingling/numbness approximately 30 minutes after receiving the vaccine. Evaluated in ED - said it felt like tongue and throat were swelling. No immediate intervention required. Discharged with diphenhydramine oral PRN, famotidine 20mg BID, prednisone 60mg Daily x 3 days and EPiPen
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| 35 | 2021-01-19 | chills, weakness, fatigue, sweating, fever |
Developed fever of 101.3 at it's highest (yesterday evening). Accompanied by sweats (soaked through ...
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Developed fever of 101.3 at it's highest (yesterday evening). Accompanied by sweats (soaked through clothes/bed sheets), chills/trembles, fatigue, general aches and weakness, acute soreness at the muscle. Following morning woke up still with 100F temp, last took tylenol at 8am, fever has since remained down/normal (it is now 3pm). Still with some sweats/feeling hot, though temp is staying normal.
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| 35 | 2021-01-19 | weakness, headache |
Felt okay upon awakening at 06:30am. Got a shower before work. Shortly after getting out of the show...
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Felt okay upon awakening at 06:30am. Got a shower before work. Shortly after getting out of the shower I became weak, ears started blocking, and started to have tunnel vision. Progressively got worse and was able to sit with head between legs. Took about 1 minute before I didn't feel like I was going to pass out. Shaky and weak after. Pulse 78 and oxygen level ok. Completed virtual visit and no further medical treatment advised unless symptoms got worse, but advised it was likely a vaccine reaction. Shortly after a bad headache and body aches developed (expected side effects).
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| 35 | 2021-01-19 | fatigue, headache, fever, chills |
Fever 102.6, chills, body aches, extreme fatigue, headache and nausea. Started 2.5 hrs after vaccina...
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Fever 102.6, chills, body aches, extreme fatigue, headache and nausea. Started 2.5 hrs after vaccination and has continued. Following up with PCP for further actions to return to work
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| 35 | 2021-01-19 | fever, fatigue |
Fever, then 1/19/21 at 10:00am metallic taste in mouth followed by severe fatigue and body aches and...
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Fever, then 1/19/21 at 10:00am metallic taste in mouth followed by severe fatigue and body aches and back spasms
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| 35 | 2021-01-19 | headache |
I received the injection and felt fine without any noticeable reactions until approximately 50 minut...
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I received the injection and felt fine without any noticeable reactions until approximately 50 minutes later when I developed a strange headache. It felt as though I had eaten ice cream too quickly and had "brain freeze". This lasted for about an hour, was fairly mild and I didn't take any medication for it nor did I contact any medical professional.
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| 35 | 2021-01-19 | night sweats, fatigue, chills, fever |
Onset of chills and fever to 101.5 about 11 hours after injection. Responded well to OTC Acetaminoph...
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Onset of chills and fever to 101.5 about 11 hours after injection. Responded well to OTC Acetaminophen. 18 hours later, chills, fatigue and temperature returned, responded to Acetaminophen. Persistent night sweats for 5 consecutive nights.
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| 35 | 2021-01-19 | throat irritation |
Patient was instructed to be monitored for 30 mins due to prior allergic reactions. The patient comp...
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Patient was instructed to be monitored for 30 mins due to prior allergic reactions. The patient complained of throat itchiness around 25mins into observation.
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| 35 | 2021-01-19 | headache | Sore arm and headache. |
| 35 | 2021-01-19 | body temperature increased, shortness of breath, chills | body aches, chills, temp 101.4, mild SOB, site pain (site hot and swollen) |
| 35 | 2021-01-19 | headache, fatigue |
body aches; fatigue; headache; This is a spontaneous report from a contactable nurse reporting for h...
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body aches; fatigue; headache; This is a spontaneous report from a contactable nurse reporting for herself. A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at left arm on 08Jan2021 14:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included Seasonal allergies. Concomitant medications included omeprazole and Multivitamin. The patient historic vaccine included the first dose of BNT162B2 received on 18Dec2020 07:30 AM at Left arm for covid-19 immunization, 1st dose symptoms started about 4hrs after: Nausea, body aches, fatigue, severe headache-all lasting 3-4 days. The patient experienced on and off headaches, body aches, fatigue all starting around 18-20 hours post second injection on 09Jan2021 and lasting less than 48 hours. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Jan2021.
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| 35 | 2021-01-19 | headache, fatigue |
nausea; body aches; fatigue; severe headache; This is a spontaneous report from a contactable nurse ...
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nausea; body aches; fatigue; severe headache; This is a spontaneous report from a contactable nurse (patient). This 35-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730) on 18Dec2020 at 07:30 AM, in left arm, for COVID-19 immunisation. Medical history included seasonal allergies. The patient had no COVID prior vaccination. No other vaccine was given in 4 weeks. Concomitant medications were not reported. About 4 hours after vaccination, on 18Dec2020 at 11:30 AM, the patient experienced nausea, body aches, fatigue and severe headache, all lasting 3-4 days. The events resolved on an unspecified date in Dec2020 without any treatment. COVID was not tested post vaccination. The second dose of BNT162B2 vaccine dose was given on 08Jan2021 at 14:30.
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| 35 | 2021-01-19 | fever, chills, fatigue, headache |
received my 2nd shot at 9:24 AM on 01/17/21, Symptoms started 1/17/2021 @ 10:30 PM chills, muscles p...
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received my 2nd shot at 9:24 AM on 01/17/21, Symptoms started 1/17/2021 @ 10:30 PM chills, muscles pain, fatigue, headache, fever, arm soreness around injection site as well as swollenness, symptoms subsided as of 01/19/21 around 11:30, 12 noonish
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| 35 | 2021-01-20 | headache, fatigue |
fatigue; Headache; This is a spontaneous report from a Non-contactable other healthcare professional...
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fatigue; Headache; This is a spontaneous report from a Non-contactable other healthcare professional (HCP). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided, NDC 59267-1000-1), intramuscular at right arm on 12Dec2020 14:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue and a headache for 2 days on an unknown date. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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| 35 | 2021-01-21 | headache, chills |
Headache developed before 7pm. Chills soon after for the remainder of the night. Woke up the next mo...
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Headache developed before 7pm. Chills soon after for the remainder of the night. Woke up the next morning feeling like hit by a bus with so many muscle aches. Also was warm/hot most of the day. Didn't feel good in general. Headache came and went most of the day. The next morning still felt 'off', but not horrible like the previous day.
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| 35 | 2021-01-21 | weakness |
Patient reported all energy and strength was wiped out of her. She slowly regained over a few days....
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Patient reported all energy and strength was wiped out of her. She slowly regained over a few days. She has numbness and loss of sensation in whole left side of body, limp and sluggish. Went to ER 01/18/20 and they thought was overload of immune system. They suggested her to report. Symptoms did not subside until 01/22/21, gradually the feeling came back, with rest. She was off work the last week to rest up.
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| 35 | 2021-01-21 | weakness, nerve pain, fever, fatigue |
Second vaccine 1/8/21: 10 hours post vaccine there was a 103 degree fever for 30 hours with sharp 9/...
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Second vaccine 1/8/21: 10 hours post vaccine there was a 103 degree fever for 30 hours with sharp 9/10 muscle pain and partial awareness to time place and location. Fatigue and pain and nauseas and weakness continued up until day 5. At day 5 8pm: loss of sensation in feet and legs, unable to ambulate, day 6: hospitalized for 7 days. Currently in inpatient acute rehab to re learn how to walk. Sharp painful neuropathy ongoing.
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| 35 | 2021-01-21 | somnolence, nasal congestion, throat pain, fever |
Within an hour was feeling jumpy, easily startled, foggy thinking, fever (highest 101.6 normal temp ...
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Within an hour was feeling jumpy, easily startled, foggy thinking, fever (highest 101.6 normal temp is 97.5), unable to sleep for over 2 days (still haven?t slept partly due to extreme pain), extreme pain all over body especially on left side, racing heart (103 while laying down normal resting is 78), fever would not go down with any amount of fever reducer for 2 days (starting to slowly go down), sore throat, swelling in ankles and feet for two days (is going down now), congested nose, severe ear pain, joint stiffness and extreme ache. Itchy all over body and rash on back. I received the vaccine on 1/20 it is now 1/22 and most are still present though some are getting better very slowly. I did not seek medical care as no one would see me so I just have isolated myself and checked in with a good friend regularly. I just felt it important to report this as no one warns how bad the reaction may be and unlike with the first dose, absolutely no check ins from hospital. I find that to be completely unacceptable.
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| 35 | 2021-01-21 | chills, fever | fever, chills, body aches, injection site soreness |
| 35 | 2021-01-23 | dizziness, malaise, thirst |
patient walked into the post vaccination site. was sitting in chair states, "I am hot and thirsty" ....
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patient walked into the post vaccination site. was sitting in chair states, "I am hot and thirsty" . Patient then went limp in chair. when called by name she woke up then lost consciousness. Patient was placed in a W/C brought into med room to lay down. pt awake and breathing VS taken. drinking water. Vs continued to be monitored . Patient states, " I am really lightheaded and do not feel well'. Rapid response called, patient taken to ER. on a gurney with 2 nurses. Husband was notified, and updated.
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| 35 | 2021-01-24 | head discomfort, dizziness |
1/14/21 Developed aching to my left underarm/armpit area while at rest. Aching has been ongoing and...
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1/14/21 Developed aching to my left underarm/armpit area while at rest. Aching has been ongoing and intermittent. 1/17/21 Developed left ear "fullness". On 1/20/21 went to GYN for exam, explained left underarm pain, told that my breast exam appeared normal, but she questioned if my left ear fullness and left under arm pain were related. 1/21/21 Left Ear "fullness" began to radiated causing left temporal pressure, spreading across forehead. Pressure developed behind both eyes. Sudden onset of dizziness occurred. Went to urgent care where they said I had swollen lymph nodes and believed I was having a auto immune response to something. Told I received the vaccine on 1/7/21, they said the symptoms could be related to the vaccine. 1/22/21 Notice I would occasionally feel like I had a "lump or pressure" to the side of my throat. As of present I am continuing to have Left Ear "fullness", left underarm aching, and bilateral eye pressure has bee intermittent yet ongoing.
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| 35 | 2021-01-24 | fever, headache |
Body aches, headache and fever up to 104.1 degrees taken orally.; Body aches, headache and fever up ...
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Body aches, headache and fever up to 104.1 degrees taken orally.; Body aches, headache and fever up to 104.1 degrees taken orally.; Body aches, headache and fever up to 104.1 degrees taken orally.; This is a spontaneous report from a non contactable nurse. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK5730), intramuscular on 11Jan2021 07:00 at single dose for covid-19 immunisation. Medical history included Allergies, anxiety, depression. Concomitant medication included sertraline, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took minocycline and experienced drug hypersensitivity. The patient received 1st dose of bnt162b2 on 21Dec2020 10:00 AM Intramuscular at Left arm. The patient experienced Body aches, headache and fever up to 104.1 degrees taken orally. The outcome of the events was resolving. No follow-up attempts are possible. No further information is expected.
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| 35 | 2021-01-24 | chills, dizziness | Dizziness, chills and tremors. |
| 35 | 2021-01-24 | fatigue | Fatigue, irregular menstrual cycle, early perimenopause symptoms |
| 35 | 2021-01-24 | headache, fatigue |
Headache, bone pain, fatigue, body aches were present when I woke Sunday morning I slept 28 hours an...
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Headache, bone pain, fatigue, body aches were present when I woke Sunday morning I slept 28 hours and awoke Monday morning still having a severe headache. Headache responds minimally to ibuprofen.
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| 35 | 2021-01-24 | sweating, headache, fever |
Heart Palpitations; Sinus tachycardia; high blood pressure; fever; woke up in a pool of sweat; heada...
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Heart Palpitations; Sinus tachycardia; high blood pressure; fever; woke up in a pool of sweat; headache; ringing in her ears; Potassium was a little low, it was 3; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EK9231, expiration date Apr2021) intramuscularly on 12Jan2021 (between 8:30 to 9 am) at left deltoid for Covid-19 prevention. The first dose was received on Wednesday (unspecified date). Patient had no medical history and had no concomitant medications. At night of 12Jan2021, the patient had a fever of 102, but she went to bed with it and she woke up in the morning around 4:30 or 5 am (13Jan2021) in a pool of sweat, so she took her temperature and she was fever with 103.6. Patient took Motrin (Store Brand, lot number as either: 0GE2417A or OGE2417A, expiry: Apr2022) three 200 mg tablets, for a totally of 600 mg for the fever and had a cold shower, and the temperature came down to 103. Then after like 10-15 minutes of her laying on the couch with ice packs on her arms and stuff, it went down to 102.6. Patient was not going to go to the ER for just the fever, but then she started having heart palpitations, and she took her blood pressure and it was 170/113 and her heart rate was 176. Patient went to the hospital, and when they took her heart rate, it was 156. She had her blood taken at the hospital and everything was normal, except that her Potassium was a little low, it was 3. The ER did an EKG that showed Sinus Tachycardia and she was given IV Fluids (two boluses of 0.9% Normal Saline, 2000 mL total via IV, a bag of Potassium IV, two oral tablets of Potassium, unspecified total dose), and everything went back down. She had to call out from work that day and planed to follow up with her Primary Care Physician (PCP) in a couple of days. Patient was no longer had the fever, high blood pressure or high heart rate, as when she left the ER this morning, her temperature was 98, blood pressure was 111/82, and her heart rate was 96. She felt good now, but she did not know if it could happen again. Patient thought that it was maybe just her immune response to the vaccine, so she would say that she has recovered probably close to completely. Patient also had a headache and ringing in her ears, and those had resolved by now as well. The events Fever, Sinus tachycardia, Heart Palpitations, high blood pressure resolved on 13Jan2021 and other event resolved in Jan2021. The patient stated that the events (Fever, Sinus tachycardia, Heart Palpitations, high blood pressure) could have been serious with her blood pressure being so high, but it was not so serious because she did the right thing and went to the ER for treatment and got fluids. She believes the events (Fever, Sinus tachycardia, Heart Palpitations, high blood pressure) are medically significant. The patient believes that the events she experienced were directly caused by her receiving the vaccine, as she has never had these symptoms before other than she of course has had fevers in her life in the past.; Sender's Comments: A possible contribution role of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) to the onset of the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 35 | 2021-01-24 | headache, fatigue |
I have had ongoing fatigue, headaches, waves of nausea, dry mouth. It is still ongoing more than 2 w...
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I have had ongoing fatigue, headaches, waves of nausea, dry mouth. It is still ongoing more than 2 weeks out. I am unable to exercise. I sometimes have to get back in bed later in the day because of fatigue.
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| 35 | 2021-01-24 | throat swelling |
Numbness and swelling of the face, throat and hands. No difficulty breathing or swallowing, Denies p...
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Numbness and swelling of the face, throat and hands. No difficulty breathing or swallowing, Denies pain. Pt reports that symptoms are similar to covid illness in November.
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| 35 | 2021-01-24 | throat pain, cough |
On the 26th, I had a sore throat that persisted, cough and loss of voice. I was out of work for abo...
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On the 26th, I had a sore throat that persisted, cough and loss of voice. I was out of work for about 5 days.
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| 35 | 2021-01-24 | weakness |
Right facial numbness from cheek to jaw line. Weakness to jaw. Symptoms lasted 9 hrs and then reoc...
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Right facial numbness from cheek to jaw line. Weakness to jaw. Symptoms lasted 9 hrs and then reoccurred 9 days later.
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| 35 | 2021-01-24 | throat swelling, weakness, dizziness, fatigue, headache |
Swollen Tongue or Throat Nausea/Vomiting Headache Fatigue Dizziness Muscle aches Weakness Localized...
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Swollen Tongue or Throat Nausea/Vomiting Headache Fatigue Dizziness Muscle aches Weakness Localized pain and swelling at injection site
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| 35 | 2021-01-24 | headache |
Within 10 minutes I was numb with a hot, tingly sensation from my left knee up to my neck and my lef...
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Within 10 minutes I was numb with a hot, tingly sensation from my left knee up to my neck and my left wrist up my arm to my neck. Then I felt like I had been hit in the head with a bat, but the pain migrated from side to side in my head. It was a very strange feeling. The hot, tingly numbness lasted about 45 minutes to an hour, the headache began to subside after 2 hours. The next day I had a little raised redness and the injection site and a bad headache, but was otherwise fine. At the vaccination site they strongly advised I go to the ER, which I did. I have no history of vaccine reaction.
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| 35 | 2021-01-24 | fever, chills, nasal congestion, headache |
headache; fever to 101F; chills; body aches; congestion; This is a spontaneous report from a contact...
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headache; fever to 101F; chills; body aches; congestion; This is a spontaneous report from a contactable physician. This physician reported for a 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Dec2020 at single dose for COVID-19 immunization. The patient's medical history included diagnosed with COVID on 10Jul2020 and 11 weeks of prolonged illness. The patient's concomitant medications were not reported. Patient with no significant risk factors except for a BMI of 34. On day 33 (13Aug2020) post diagnosis she was PCR and IgG positive. On 01Dec2020, patient had the first Pfizer Covid vaccine dose. The first 2-5 days (Dec2020) were described as very bad, fever to 101F, chills, headache, body aches, congestion. The week after she was somewhat better but didn't feel better until day 9 post vaccination. Outcome of the events was unknown. Information on the Lot/batch number has been requested.
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| 35 | 2021-01-25 | dizziness |
10 min after injection became dizzy. BP 130/102, HR 105/107 SPO2 99%, T 97.7 Started taking Zoloft...
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10 min after injection became dizzy. BP 130/102, HR 105/107 SPO2 99%, T 97.7 Started taking Zoloft 50 mg QD 1.5 weeks ago Had COVID in Nov 2020 BP recheck 146/88, HR 98, Dizziness resolved @10:50AM
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| 35 | 2021-01-25 | chills, headache, fatigue, fever | Fever, Chills, body aches, fatigue, and headache |
| 35 | 2021-01-25 | chills, sweating, fever, dizziness, headache, dehydration |
First dose no effect. Went into second dose mildly dehydrated, went for a hike and at +6 hrs, myalgi...
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First dose no effect. Went into second dose mildly dehydrated, went for a hike and at +6 hrs, myalgias. At +12 hours mild anorexia, nausea, periorbital headache, myalgias. At +14 hours, fevers, throbbing headache, sweats, chills, arthralgia and myalgias, lightheadedness, dizziness, nausea with dry heaves. All symptoms subsided by 25 hours post- injection without residual effects at all.
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| 35 | 2021-01-25 | headache, fatigue | PAIN AT INJECTION SITE- MODERATE PAIN FOR 24 HRS; HEADACHE-MODERATE 24 HRS; FATIGUE 24 HRS |
| 35 | 2021-01-25 | shortness of breath |
PRESENTING PROBLEM: Bilateral pulmonary embolism (HCC) HOSPITAL COURSE: 35-year-old female came in ...
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PRESENTING PROBLEM: Bilateral pulmonary embolism (HCC) HOSPITAL COURSE: 35-year-old female came in with shortness of breath and pleuritic chest pain who was found to have bilateral pulmonary embolism with moderately extensive clot burden. Her BNP and troponins were normal and no signs of right ventricular dysfunction on CT scan. Patient was placed on heparin drip and her symptoms improved. Ultrasound Doppler of bilateral lower extremities were negative. This was an unprovoked PE. Patient was switched to and discharged with Xarelto. She will benefit from a hypercoagulable workup once she is off of anticoagulation. After vaccine: patient reported difficulty breathing and fast heartrate
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| 35 | 2021-01-25 | fatigue, headache |
Swollen and tender left neck lymph node; Swollen and tender left neck lymph node; Headache; Tirednes...
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Swollen and tender left neck lymph node; Swollen and tender left neck lymph node; Headache; Tiredness; This is a spontaneous report from a contactable other health professional (HCP). A 35-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176), intramuscular on left arm, on 12Jan2021 at 09:15, at a single dose for COVID-19 immunization. Medical history included anxiety and migraine from an unknown date and unknown if ongoing. Concomitant medication included escitalopram. The patient received the first dose of BNT162B2 (lot number: EH9899), intramuscularly on left arm at 23Dec2020, 03:30 PM. The patient experienced swollen and tender left neck lymph node, headache and tiredness; all on 12Jan2021 at 17:30. There was no treatment given for the events. The outcome of the events was not recovered.
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| 35 | 2021-01-25 | shortness of breath |
Systemic: Rash (other than injection site)-Mild, Systemic: Other- Shortness of breath, itching, thro...
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Systemic: Rash (other than injection site)-Mild, Systemic: Other- Shortness of breath, itching, throat tightening; symptoms lasted 1 day
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| 35 | 2021-01-25 | headache |
day 5 of the second shot I woke up extremely hot, felt like my skin And everything around me was bu...
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day 5 of the second shot I woke up extremely hot, felt like my skin And everything around me was burning/overheating; I also had mild hot flashes after the second vaccine and headaches; I also had mild hot flashes after the second vaccine and headaches; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685) intramuscular at left arm on 06Jan2021 10:30 at single dose for COVID-19 immunization. Medical history included Asthma, hypothyroidism, ADD. Concomitant medications were not reported. Patient had known allergies to erythromycin and seasonal allergies. it was unknown if covid prior vaccination. There were other medications in two weeks. Patient used took first dose of BNT162B2 (lot number: Ej1685) on 17Dec2020 at left arm at single dose for COVID-19 immunization and experienced extreme episode of overheating (at night) the first time, got up and almost passed out. It was reported day 5 after both shots patient had an extreme episode of overheating (at night) the first time she got up and almost passed out. day 5 of the second shot she woke up extremely hot, felt like her skin and everything around her was burning, it was inescapable, she had to open a window and wait it out, lasted about 30 minutes. she also had mild hot flashes after the second vaccine and headaches. adverse event start date was 10Jan2021. No covid tested post vaccination. no treatment received for the events. Patient was recovering from the events.
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| 35 | 2021-01-25 | dizziness, throat irritation |
lightheadedness; throat became scratchy; tongue felt thick; hives; itching; This is a spontaneous re...
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lightheadedness; throat became scratchy; tongue felt thick; hives; itching; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: E-1284), intramuscular in the right arm on 12Jan2021 at 14:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and allergy to IV contrast. The patient was not pregnant at the time of vaccination, had no other vaccine within four weeks, and did not have COVID prior to vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID; reported as other medication within 2 weeks). On 12Jan2021, less than 5 minutes after administration (also reported as at 02:15PM), the patient experienced lightheadedness, throat became scratchy, tongue felt thick, hives, and itching. These were resolved with Benadryl, Pepcid, Zyrtec, and IM steroids (also reported as PO and IM medications). It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. The patient has not tested positive for COVID post vaccination. Outcome of the events was recovered/resolved (also reported as recovering). Information on the lot/batch number has been requested.
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| 35 | 2021-01-25 | cough, body temperature increased, runny nose, chills |
mild chills; Temp 99/Temp spiked to 101 at 1500; Body aches/body aches- especially back/ hips; Sligh...
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mild chills; Temp 99/Temp spiked to 101 at 1500; Body aches/body aches- especially back/ hips; Slight post nasal drip; cough; This is a spontaneous report from a contactable nurse. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:5730), intramuscular in left arm on12Jan2021 19:00 at single dose for covid-19 immunization. The patient's medical history included known allergies to Penicillin (PCN). Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously took Levaquin and versed and experienced allergies. The patient received the first dose of bnt162b2 (lot:5730) on 21Dec2020 at 18:30, intramuscularly in the right arm for covid-19 immunisation. On 12Jan2021 07:00, events started 12 hours of out with mild chills. Temp 99. Body aches. Took Tylenol 0900, symptoms improved to tolerable range. Temp spiked to 101 at 1500. Chills, body aches- especially back/ hips. Slight post nasal drip and cough. The outcome of the events was not recovered
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| 35 | 2021-01-26 | fatigue, fever, headache |
Beginning the morning after my second vaccine dose, I experienced body aches, joint pain, nausea, di...
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Beginning the morning after my second vaccine dose, I experienced body aches, joint pain, nausea, diarrhea and fatigue. By 24 hours post-vaccine, I developed a fever of 100.8, a headache, and swollen lymph nodes. By 36 hours, my fever broke, diarrhea discontinued, and the headache subsided. The body aches, nausea, fatigue, and swollen lymph nodes continue to inhibit my ability to perform ADLs and I was unable to work today.
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| 35 | 2021-01-26 | fever, headache |
Developed nausea and headache the day of the appt. The night of the vaccine developed a 101 degrees ...
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Developed nausea and headache the day of the appt. The night of the vaccine developed a 101 degrees temperature with worsening headache and nausea
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| 35 | 2021-01-26 | headache, chills |
Shortly after the Pfizer covid 19 vaccine was administered the patient complained of a severe headac...
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Shortly after the Pfizer covid 19 vaccine was administered the patient complained of a severe headache. Her BP was checked and was 206/110 using a wrist monitor... 142/96 using a manual BP apparatus and stethoscope after 30 mins... pt felt chills and was cold. Complained of nausea 5 mins before EMT arrived.
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| 35 | 2021-01-26 | chills, headache |
Was fine until about 8:00-8:30 at night was extremely nauseous, and a slight headache started to for...
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Was fine until about 8:00-8:30 at night was extremely nauseous, and a slight headache started to form. On 1/26/21 the nausea was worse with a headache that resemble a migraine and hot cold chills, never had a fever.
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| 35 | 2021-01-26 | fatigue, chills |
body aches, chills, fatigue, and generalized headache vaginal bleeding that started 01/27/2021 (have...
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body aches, chills, fatigue, and generalized headache vaginal bleeding that started 01/27/2021 (have a Mirena and have not had menstrual bleeding in 3 + years)
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| 35 | 2021-01-26 | fatigue, chills, fever | fatigue, muscle aches, joint pain, chills, fevers to 102 F, chest pain, nausea, stomach pain |
| 35 | 2021-01-26 | chills, fatigue, fever |
injection site soreness (1/26/21 to current), axillary swelling on side of injection (1/26/21 to cur...
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injection site soreness (1/26/21 to current), axillary swelling on side of injection (1/26/21 to current), fever (1/26/21 to 1/27/21), body aching (1/26/21 to current), chills (1/26/21 to 1/27/21), intense fatigue (1/26/21 to current), feeling cognitively fuzzy (1/26/21 to current) awaiting resolution of fatigue, cognitive fuzziness, and axillary swelling no treatment at this time unless these symptoms do not resolve
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| 35 | 2021-01-26 | headache |
some severe nausea to the point started on the 11Jan2021 that was very hard for her to talk to peopl...
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some severe nausea to the point started on the 11Jan2021 that was very hard for her to talk to people; Soreness in my arm; Headache; This is a spontaneous report from a contactable consumer reported for self. This 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. And right after the vaccine the patient was okay. Into the next day (07Jan2021) the patient had soreness in her arm, and headache which was known as a common side effect of the vaccination. But as of Monday, had been experiencing some severe nausea to the point started on the 11Jan2021 that was very hard for her to talk to people. Because she was almost gag in. Every time she talked she felt like she was going to throw up just if she was upright she felt like she had to throw up. So, she reached out to her employee health services and they asked her to reach out to you guys. She just wanted to add that she didn't experience this portion right away, it took some days for her to feel this. No treatments received for the event nausea. Outcome of the event nausea was not recovered. Outcome of other events was unknown. information on the lot/batch number has been requested.
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| 35 | 2021-01-27 | fatigue |
Breakthrough bleeding/spotting menses; soreness at injection site; fatigue; muscle aches; This is a ...
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Breakthrough bleeding/spotting menses; soreness at injection site; fatigue; muscle aches; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 35-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 10:00 at single dose in Left arm for COVID-19 immunization. Medical history included Alports, Alopecia Areata, eczema, all from an unknown date and unknown if ongoing. There were no known allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC), lisinopril. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient experienced Breakthrough bleeding/spotting menses, soreness at injection site, fatigue, muscle aches on 23Dec2020 20:30. No treatment received for all reported events Breakthrough bleeding/spotting menses, soreness at injection site, fatigue, muscle aches. The patient underwent lab tests which included blood test for covid-19 which named SARS-COV-2 IGG on 09Jun2020 was with result Negative and covid-19 test which named SARS-COV-2 BY PCR (2019-NCOV) via Nasal Swab post vaccination on 30Dec2020 was with result Negative. The outcome of the events was recovered on an unspecified date.
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| 35 | 2021-01-27 | fever, headache, chills |
Fever; chills; muscle aches; pain at injection site; headache; chest pain; This is a spontaneous rep...
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Fever; chills; muscle aches; pain at injection site; headache; chest pain; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration in right arm on 12Jan2021 at single dose for covid-19 immunisation. Medical history included sulfa allergy, canteloupe allergy. The patient's concomitant medications were not reported. No any other medications the patient received within 2 weeks of vaccination. The patient previously received 1st dose of BNT162B2 (lot# EJ1685) via intramuscular in right arm on 22Dec2020 13:00 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, muscle aches, pain at injection site, headache, chest pain on 12Jan2021 17:00. The patient was not pregnant. No treatment received for the events. The outcome of events was recovered on an unspecified date of Jan2021. This case was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 35 | 2021-01-28 | throat irritation |
? Day 10 after vaccine #1 upper lip swelling AKA angioedema ? Day 6 post vaccine #2 lower right lip ...
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? Day 10 after vaccine #1 upper lip swelling AKA angioedema ? Day 6 post vaccine #2 lower right lip and upper right lip swelling. Scratchy throat ? Day 10 post vaccine #2 wheezing like an asthma attack ? Day 12 post vaccine #2 Left, lower lip swelling, tingling in my tongue ? itchy for 2 weeks, 14 days post vaccine #2. Developed a sporadic, ever changing rash ? Day 16 post vaccine #2 a different, new rash
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| 35 | 2021-01-28 | fever, fatigue, malaise, throat pain |
Nausea; Slight temperature 99.7; Fatigue; General feeling of aches and pains; Sore throat; Throat se...
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Nausea; Slight temperature 99.7; Fatigue; General feeling of aches and pains; Sore throat; Throat seemed red; Sick; Feeling heavy with her chest. She went to the ER; This is a spontaneous report from a contactable nurse. This nurse reported for a 35-year-old female patient (Daughter) received 2nd dose of BNT162B2 (COVID-19 Vaccine lot number: EK9231, Expiry date: Apr2021) on 16Jan2021 at single dose for covid-19 immunization. Medical history reported was She was positive, our whole family had COVID and we all came down which was about the same time which was 29Dec. Concomitant drug were not reported. Retired Nurse stated, "I am calling for my daughter. She received her 2nd vaccination yesterday morning and she had some side effects. Like about 6 o'clock this morning she came in, she came in 6:35, she came and woke me up and said that she felt some of the reaction she is having. She has nausea, she has slight temperature 99.7, fatigue. Just a general feeling of aches and pains. It does not seem like it's an emergency. She was treated in the ER with steroids and since that point we have all recovered until she went for the 2nd. She works in a hospital, she got her 2nd dose of vaccine like I said yesterday morning. "Retired Nurse stated, "I am not sure causality. I mean it is not an emergency. She was feeling fine yesterday. We all are feeling better now. She had the vaccine and last night she said she had a sore throat when I looked at her throat. Her throat seemed red but there was no angioedema or anything like that, she went to sleep and she came in 'feeling really' (voice distortion) sick. So, I do not know. Did they have relapses from the COVID? I do not know." Treatment was "Tylenol." Like I had said that she was feeling heavy with her chest. She went to the ER. She was at her work. She went to the ER." "Probably close to 10 days ago, they did lab work I think they might have been looking for a clot. They did do some lab work at the hospital with unknown results." Outcome of the event was unknown. No follow-up attempts possible. No further information expected.
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| 35 | 2021-01-28 | nerve pain |
The post-injection inflammation made my spinal arthritis go nuts, causing muscle spasms, severe nerv...
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The post-injection inflammation made my spinal arthritis go nuts, causing muscle spasms, severe nerve pain, and numbness in my hands. Prescription anti-inflammatory helped.
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| 35 | 2021-01-28 | fever |
Troponin, which is a cardiac enzyme or a heart test to be high; test continued to stay high for the ...
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Troponin, which is a cardiac enzyme or a heart test to be high; test continued to stay high for the 24 hours when they have done three different test at 8 hours apart; I might have myocarditis which is inflammation of the heart muscle as a result of the vaccine; I am having side effects affecting the heart because my cardiac enzymes are high; Rash that can happen from low platelet on both of my arm, for which I came to the emergency room; Rash that can happen from low platelet on both of my arm, for which I came to the emergency room; I am having side effects affecting skin because I am having rash; I am side effects affecting the immune system because my lymph nodes are enlarged; I have swelling at the site of injection; My lungs because I was wheezing; I was having lung symptoms; I have any irregular rhythm; I started having low grade fever and myalgia; I had similar low grade fever and myalgia with my first dose; I started having low grade fever and myalgia; I had similar low grade fever and myalgia with my first dose; I started having high grade fever, maximum temperature of 101.5 degree Fahrenheit; Wheezing; Dyspnea on excursion which is basically shortness of breath when I go up and down on the stairs; Chest tightness; This is a spontaneous report from a contactable Physician (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunisation. Medical history included asthma exercise induced from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received the first dose of BNT162B2 on unknown date and experienced low grade fever and myalgia. On 15Jan2021 the patient experienced Dyspnea on excursion which is basically shortness of breath when I go up and down on the stairs; Chest tightness; I started having high grade fever, maximum temperature of 101.5 degree Fahrenheit; Wheezing. On 16Jan2021 the patient experienced rash that can happen from low platelet on both of my arm, for which I came to the emergency room (hospitalization). On unknown date the patient experienced Troponin, which is a cardiac enzyme or a heart test to be high; test continued to stay high for the 24 hours when they have done three different test at 8 hours apart (hospitalization); I might have myocarditis which is inflammation of the heart muscle as a result of the vaccine (hospitalization); having side effects affecting the heart because my cardiac enzymes are high (hospitalization); I have any irregular rhythm; I started having low grade fever and myalgia; I had similar low grade fever and myalgia with my first dose; I am having side effects affecting skin because I am having rash; I am side effects affecting the immune system because my lymph nodes are enlarged; I have swelling at the site of injection; My lungs because I was wheezing; I was having lung symptoms. The patient underwent lab tests and procedures which included blood test: unknown results on unknown date; body temperature: 101.5 fahrenheit on 15Jan2021, chest x-ray: unknown results on unknown date; echocardiogram: unknown results on unknown date; EKG: unknown results on unknown date, cardiac enzyme: high on 16Jan2021, platelet count: low on unknown date . The outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 35 | 2021-01-31 | dizziness, fatigue |
At 11:30am the next day after receiving the second dose, I became extremely fatigued and felt dizzy ...
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At 11:30am the next day after receiving the second dose, I became extremely fatigued and felt dizzy and very nauseous. On the morning of 1/31/21, I felt the exact same symptoms but this time the nausea led to vomiting.
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| 35 | 2021-01-31 | fatigue, malaise, chills, headache |
Chills (no fever), myalgia, arthralgia, fatigue, malaise, headache, right arm soreness. No treatment...
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Chills (no fever), myalgia, arthralgia, fatigue, malaise, headache, right arm soreness. No treatment given except rest. Lasted ~24 hours.
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| 35 | 2021-02-01 | fatigue, chills, fever |
1/30/21 0800 chills, muscle pain, swollen axillary lymph nodes with pain radiating to neck and down ...
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1/30/21 0800 chills, muscle pain, swollen axillary lymph nodes with pain radiating to neck and down arm 0830 nausea, vomiting 0900 fever, tylenol and ibuprofen 1300 afebrile 1/30/21 - current (2/1/21) increased fatigue, muscle aches, loss of appetite, swollen axillary lymph nodes have persisted
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| 35 | 2021-02-04 | dizziness, shortness of breath |
Began shaking and face tingling 6 minutes after shot, started to feel slightly better. 10 minutes ...
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Began shaking and face tingling 6 minutes after shot, started to feel slightly better. 10 minutes after shot, neck became red, red welts appeared on bilateral upper arms. took 25mg of po benadryl at my desk. 25 minutes after shot felt hot, dizzy, arms and legs tingling, breathless, limbs went numb, rushed to ER via wheelchair. Treated in er for anaphylaxis. Arms and legs felt covered in "icy hot," tachycardia for several hours, numerous times felt impending doom. hospitalized overnight on cardiac monitor. ER gave steroids, benadryl, pepcid, 2L ivf. ativan given later in evening for nervousness.
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| 35 | 2021-02-07 | headache, fatigue |
About 4am after the vaccination I woke up with a terrible headache took tylenol and was in bed the r...
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About 4am after the vaccination I woke up with a terrible headache took tylenol and was in bed the remainder of the day d/t extreme fatigue. About 6pm I was able to get up and move around and felt a little better and all symptoms begin to subside within about 24 hrs. 7/29/2021-Expected delivery date
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| 35 | 2021-02-16 | dizziness |
4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; 4 days after second dos...
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4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; 4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; 4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; This is a spontaneous report from a contactable nurse (reporting for herself). A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3302), at age 35 years, via an unspecified route of administration on the left arm, second dose on 29Jan2021, at single dose, for COVID-19 immunization. Medical history included breast feeding from an unknown date and unknown if ongoing, and COVID-19 on unspecified dates diagnosed prior to vaccination. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient previously took BNT162B2 on 08Jan2021 at age 35 years for COVID-19 immunization. On 02Feb2021, 4 days after the second dose, the patient experienced dizziness, nausea and was diagnosed with vertigo when seen in ER. The adverse event resulted in emergency room/department or urgent care visit. Treatment received for the adverse event includes IV fluids and meclizine. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a hospital. The outcome of the event was recovering/resolving. Case was reported as non-serious.
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| 35 | 2021-02-17 | sweating, nasal congestion |
it feels like when she has an allergic reaction; nasal congestion; chest tightness; diaphoresis; Thi...
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it feels like when she has an allergic reaction; nasal congestion; chest tightness; diaphoresis; This is a spontaneous report from a contactable pharmacist. A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), intramuscular on the left arm on 26Jan2021 10:15 at a single dose for COVID-19 immunization. Medical history included allergy to seafood. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular on the left arm on 04Jan2021 08:00 for COVID-19 immunization. The most recent COVID-19 vaccine was administered at the hospital. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient complained of nasal congestion, chest tightness, and diaphoresis approximately 20 mins after the second COVID vaccine on 26Jan2021 10:30. She had an allergy to seafood and stated this was what it felt like when she had an allergic reaction. The patient received one dose of Benadryl 50 mg IV, famotidine 20 mg IV, Solumedrol 125 mg IV, Zofran 4 mg IV and normal saline 500ml bolus. Patient became nauseated after receiving Benadryl and improved after receiving medications. The events were reported non-serious and required emergency room/department or urgent care. Outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported allergic reaction with symptoms of nasal congestion, chest tightness, and diaphoresis occurred approximately 20 mins after the second COVID vaccine is considered related to the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and the known safety profile of the suspect. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 35 | 2021-02-21 | chills, fatigue | Chills, body aches, joint pain and fatigue. |
| 35 | 2021-02-21 | fatigue, fever, throat pain, headache |
Fever, aches, headaches, fatigue, sore throat, arm pain at injection site, diarrhea, nausea Started...
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Fever, aches, headaches, fatigue, sore throat, arm pain at injection site, diarrhea, nausea Started same day and have lasted a week
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| 35 | 2021-02-21 | fever, headache |
Reported body aches, fever 100.6F, and headache. 1st dose administered on 1/28/21 Pfizer EL9262 / ...
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Reported body aches, fever 100.6F, and headache. 1st dose administered on 1/28/21 Pfizer EL9262 / 2nd dose administered on 2/18/21 Pfizer EN5318
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| 35 | 2021-02-22 | fever, fatigue, headache, throat pain, cough |
30th, I woke up with tired, sore throat, headache - continued to January 2 and I had gotten worse w...
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30th, I woke up with tired, sore throat, headache - continued to January 2 and I had gotten worse with a severe cough; fever; body aches and I called employee health line and they had me get a test for COVID and it was positive result on January 3. I did not have any treatment. I had most of the symptoms for two weeks and cough lasted for a month. I was recovered from the symptoms before getting second dose of vaccine which was January 19th.
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| 35 | 2021-02-22 | fatigue |
Beginning around 4pm on 2/22/21 I began feeling hot, but did not have a fever (98.8). I was also mor...
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Beginning around 4pm on 2/22/21 I began feeling hot, but did not have a fever (98.8). I was also more tired than usual. Later that evening my injection site was sore, itchy, and raised, like a hive. On 2/23/21 I woke up at about 7:30AM and the injection site was the same as before, but I also had a sore/stiff neck and headache at the base of my skull. The reactions have not warranted a trip to the doctor, but I remember hearing somewhere that the CDC was interested to know about any side effects that may be related to the vaccine.
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| 35 | 2021-02-22 | dizziness | Dizziness, vestibular neuritis, continuous since 1/20. |
| 35 | 2021-02-22 | cough | Hives, Angioedema, slight cough and wheezing |
| 35 | 2021-02-22 | headache, fatigue, night sweats |
Muscle and severe joint pain, lumbar, thoracic, and cervical spine pain (every vertebrae in my spine...
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Muscle and severe joint pain, lumbar, thoracic, and cervical spine pain (every vertebrae in my spine hurt like my car accident was yesterday), severe headache with horrible eye pain, nausea, injection site pain and arm weakness, sweating at night, diarrhea, sharp chest pains (like when I had covid), soft tissue between ribs hurt, gerd (reflux, over full feeling, gas, heartburn, sour stomach, pain when eating), extreme exhaustion, inability to do daily activities or go to work for one week
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| 35 | 2021-02-22 | dizziness |
pt w hx of vagal events with vaccinations and blood draws. shortly after vaccine administration, be...
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pt w hx of vagal events with vaccinations and blood draws. shortly after vaccine administration, became nauseated, pale, and dizzy. improved after 30 minutes.
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| 35 | 2021-02-23 | malaise, headache, fatigue |
maybe a little low iron but not too remarkable; swelling in middle finger of right hand/puffiness in...
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maybe a little low iron but not too remarkable; swelling in middle finger of right hand/puffiness in all of fingers and toes and around eyes; puffiness in all of fingers and toes and around eyes; she was not feeling great; fatigue; headache; soreness in her arm at the injection site; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) on her right arm, via an unspecified route of administration on 20Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on 23Dec2020, she was not feeling great, had fatigue and headache. On 25Dec2020, she had swelling in her right middle finger, states that has now progressed to swelling in all her fingers, toes and around her eyes. Also reported that on 21Dec2020, she had soreness in her arm at the injection site that went away the same day. The patient also mentioned that she tested negative for Covid. The patient is also a little low iron but not too remarkable. The outcome of the event vaccination site pain was recovered in 21Dec2020, not recovered for peripheral swelling and puffy eyes while unknown for the other events. Information on Lot/Batch has been requested.
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| 35 | 2021-02-23 | headache |
sore arm and headache overnight; sore arm and headache overnight; This is a spontaneous report from ...
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sore arm and headache overnight; sore arm and headache overnight; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration (right arm), on 11Feb2021 10:00, at single dose, for covid-19 immunization. Medical history included celiac disease. Concomitant medication included bupropion. The patient experienced sore arm and headache overnight on 11Feb2021 18:00. The patient recovered from the events on 12Feb2021. The patient took ibuprofen (ADVIL) as treatment for the events (self-prescribed). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
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| 35 | 2021-02-24 | throat pain, malaise, chills |
Chills; Arm Soreness; Malaise; sore throat; warm body feeling; This is a spontaneous report from a n...
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Chills; Arm Soreness; Malaise; sore throat; warm body feeling; This is a spontaneous report from a non-contactable consumer. A 35-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) on her right arm, via an unspecified route of administration on 04Feb2021 13:30 at a single dose for covid-19 immunization. Medical history included thyroid condition and environmental allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC) and levothyroxine. The patient experienced Chills, Arm Soreness, Malaise, slight sore throat, warm body feeling; all for 05Feb2021 10:00AM. No treatment was received for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 35 | 2021-02-25 | headache |
Headache; This is a spontaneous report from a contactable consumer reported for herself. This 35-yea...
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Headache; This is a spontaneous report from a contactable consumer reported for herself. This 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 09:15 AM Left arm at single dose (Lot # EL4237) for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history was none. No Allergies to medications, food, or other products. Prior to vaccination, the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. None other medications the patient received within 2 weeks of vaccination. Headache occurred about 1 hr after receive vaccine 26Jan2021 10:15 which was non serious, went away within 2 hours. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the event was recovered on 26Jan2021.
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| 35 | 2021-02-25 | fever, chills |
I had horrible body aches, chills, fever (100.8).It felt impossible for me to move around. I was in ...
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I had horrible body aches, chills, fever (100.8).It felt impossible for me to move around. I was in early stage of my pregnancy took a test on 1/7. My first doctor appt was 2/1 was told 8 weeks pregnant had a ultrasound didn't show any yoke or fetus. I had multiple ultrasounds done that week to enI had to have a DNC on 2/10 done and I'm still waiting on my DNA chromosomes to come back (plasenta show abnormality).(estimated date of delivery Pt stated around Sept 2021)
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| 35 | 2021-03-02 | shortness of breath |
Couldn't take a full breath. Most intense standing or laying down, lesser when seated/when exercisin...
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Couldn't take a full breath. Most intense standing or laying down, lesser when seated/when exercising like I can't take a big enough breathe; Centralized chest pain on sternum.; Felt extremely heavy, not like a regular flu. More like as asthma attack that was waiting to peak; Felt extremely heavy, not like a regular flu. More like as asthma attack that was waiting to peak; Arm soreness; Nauseous all week; loss of appetite; Sore to touch; heavy chested; medical history included Hashimoto's; medical history included Hashimoto's; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318; expiration date not provided), via an unspecified route of administration on 25Jan2021 19:00 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history included Hashimoto's, asthma, and food allergy all from unknown dates and unknown if ongoing. The patient has no COVID prior vaccination. The patient was not COVID tested post vaccination. Patient is not pregnant. Concomitant medications included levothyroxine sodium, liothyronine sodium, progesteron, and sertraline. Adverse events on 26Jan2021 at 07:00 were reported as follows: Centralized chest pain on sternum. Felt extremely heavy, not like a regular flu. More like as asthma attack that was waiting to peak (patient reported that she has asthma). Sore to touch. Couldn't take a full breath, most intense standing or laying down, lesser when seated. Lasted just over 48 hours. Patient also stated, 'Still feel heavy chested when exercising like I can't take a big enough breathe'. Patient also reported arm soreness, nauseous all week, loss of appetite. Also on period. The patient has not received treatment for the events. Outcome of the events was reported as 'Recovered with lasting effects'.
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| 35 | 2021-03-02 | fatigue |
I've had too much stomach upset; Severe heartburn; Persistent mouth dryness; The taste in my mouth c...
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I've had too much stomach upset; Severe heartburn; Persistent mouth dryness; The taste in my mouth changed; Extreme fatigue; This is a spontaneous report from contactable healthcare professional. A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 27Jan2021 09:15 at single dose (left arm) for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. The patient was not pregnant. There were no concomitant medications. The patient had no other vaccine in other 4 weeks. On 28Jan2021, at 12:00, the patient experienced too much stomach upset, severe heartburn, persistent mouth dryness, the taste in mouth changed and extreme fatigue. The patient received therapy for the events included household medication and natural treatment. The patient did not have covid prior vaccination and was not covid tested post vaccination. Outcome of events was not recovered. Information on the batch/lot number has been requested.
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| 35 | 2021-03-02 | headache, fever, fatigue, chills |
had tunnel vision ups on walking to bathroom and almost blacked out; had tunnel vision ups on walkin...
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had tunnel vision ups on walking to bathroom and almost blacked out; had tunnel vision ups on walking to bathroom and almost blacked out; Achy and restless legs; Achy and restless legs; nauseous however did not allow self to vomit; headache; fatigue; rapid heart beat; low grade fever; chills; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EM9809) via an unspecified route of administration on 16Feb2021 12:45 at single dose (left arm) for COVID-19 immunization. Medical history included hypothyroidism, and allergies: Sulfa. The patient was not pregnant. Concomitant medication included topiramate (TOPIMAX), metformin, levothyroxine, and phentermine. The patient received 1st dose of bnt162b2 for COVID-19 immunization on 26Jan2021, 12:45pm (lot EL9263). On 17Feb2021 03:30, the patient experienced achy and restless legs, nauseous however did not allow self to vomit, had tunnel vision ups on walking to bathroom and almost blacked out, headache, fatigue, rapid heart beat, low grade fever, and chills. The patient had no treatment for the events. The patient had no other vaccine in four weeks and had no covid prior vaccination. Patient was not covid tested post vaccination. Outcome of events was recovering.; Sender's Comments: A possible contribution role of the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of Tunnel vision cannot be completely excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 35 | 2021-03-02 | chills, headache |
nausea - 6hrs post shot; headache -10hrs; body aches-14hrs; chills - 14hrs; This is a spontaneous re...
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nausea - 6hrs post shot; headache -10hrs; body aches-14hrs; chills - 14hrs; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on left arm on 16Feb2021 11:30 AM at single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included hypothyroid, Allergies to amoxicillin and sulfa drugs. Concomitant medication (received within 2 weeks of vaccination) included levothyroxine sodium (SYNTHROID), buspirone hydrochloride (BUSPAR) and vitamin D. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation on 26Jan2021 at age of 35 years old. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Feb2021, the patient experienced nausea - 6hrs post shot, headache - 10hrs, body aches and chills - 14hrs. The outcome of events was not recovered. No treatment received for the adverse events. All events reported as non-serious. No follow-up attempts are possible. No further information is expected.
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| 35 | 2021-03-04 | sweating, cold sweat, shortness of breath |
Pale; Sweaty; her left arm was extremely sore; elevated heart rate/heart rate was in the 120s, and s...
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Pale; Sweaty; her left arm was extremely sore; elevated heart rate/heart rate was in the 120s, and she usually has a heart rate in the 80s; shortness of breath; approximately 22 hours after receiving her first COVID-19 Vaccine, her left arm started swelling slightly down from the COVID-19 Vaccine injection site; the COVID-19 Vaccine injection site became red, warm, and itchy; the COVID-19 Vaccine injection site became red, warm, and itchy; the COVID-19 Vaccine injection site became red, warm, and itchy; Blood pressure increased; Clammy/cold sweat; muscle tenderness/all the muscles in her left arm were tender/aching; bruising near the injection site; she had bruising (more than usual) throughout the rest of her body; she noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) the lymph nodes in her left axillary (or armpit area) were swollen, and super tender; she noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) the lymph nodes in her left axillary (or armpit area) were swollen, and super tender; anxiety; This is a spontaneous report from a contactable consumer (patient/Registered Medical Assistant). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL0142), via an unspecified route of administration on 12Jan2021 14:30 (2:30 PM) at single dose on left deltoid for COVID-19 immunization. Vaccination facility type is hospital. No history of previous immunization and no additional vaccines administered on same date of Pfizer suspect, also reported as "Prior Vaccinations (within 4 weeks): None". Medical history included ongoing Vitamin D deficiency for quite a few years. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) from Oct2020 and ongoing at 50000 IU gel cap, once weekly for Vitamin D deficiency. Patient is scheduled to receive the second dose of Pfizer vaccine on 02Feb2021 but reported side effects from her first shot including bruising near the injection site, shortness of breath, muscle tenderness and elevated heart rate (main concern). Upon contacting her HCP, she mentioned that this may be a side effect of her anxiety medications and asked "Should she take the second dose?". Approximately 22hours (13Jan2021) after receiving her first COVID-19 Vaccine, her left arm started swelling slightly down from the COVID-19 Vaccine injection site. COVID-19 vaccine injection site became red, warm, and itchy, also experienced blood pressure increased, shortness of breath and Clammy, all on 13Jan2021. The patient was pale on 13Dec2020. Patient noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) that the lymph nodes in her left axillary (or armpit area) were swollen, and super tender (onset reported as "Jan2021"). Patient became sweaty on 14Jan2021. It was further reported that patient received her first COVID-19 Vaccine dose on 12Jan2021 2:30PM . She said after receiving the first COVID-19 Vaccine, she has had multiple symptoms. Patient is now due for her second COVID-19 Vaccine dose today 02Feb2021. Patient did not know if she should get the second COVID-19 Vaccine dose, and if her side effects were from the first COVID-19 Vaccine. Patient works in a doctor's office where there is a medical doctor, nurse practitioner, and several other registered medical assistants. Approximately 12 hours later after vaccine, at 2:30AM (13Jan2021), her left arm was extremely sore. She said she went to work on Wednesday, 13Jan2021, and her left arm was still really sore, but she was fine, otherwise. She said approximately 22 hours after receiving her first COVID-19 Vaccine, her left arm started swelling slightly down from the COVID- 19 Vaccine injection site. She said her COVID-19 Vaccine was given a lot higher than she thinks the vaccine should have been given. She said the COVID-19 Vaccine injection site became red, warm, and itchy. Her heart rate and blood pressure shot up, and she had pretty bad shortness of breath. Patient said that the medical doctor and nurse practitioner (where she works) told her she gave herself a panic attack. She said that the medical doctor, who she works for, told her to go home, and to contact her primary care doctor if she doesn't feel better. Patient left work and went home. Patient clarified her heart rate was in the 120s, and she usually has a heart rate in the 80s. She said she was pale and clammy, too. Patient stated that she went to bed when she got home from work on 13Jan2021, and woke up the next morning (Thursday, 14Jan2021), and got ready for work. She said as she was getting dressed for work, she felt her pulse rate go up, and she became sweaty, and clammy. She said she called her work, and her boss (medical doctor) told her to take some Tylenol and rest, and to call her primary care doctor if she was not feeling better. Patient said that her primary care doctor said she was having anxiety, and started her on medicine. She said the medicine helped, but her heart rate was still 112-115. She said she noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) the lymph nodes in her left axillary (or armpit area) were swollen, and super tender. She said all the muscles in her left arm were tender, as well. She said her left arm muscles were still aching. She said she had bruising on her left arm, and noticed she had bruising (more than usual) throughout the rest of her body. She said she has no idea if the bruising is a coincidence, or if the bruising is related to receiving the COVID-19 Vaccine. Patient mentioned that her left axillary lymph nodes were swollen for a good week and a half, but the swelling improved and was gone now. She said her heart rate was still elevated at 106-110 when she last checked her heart rate an hour and half ago. She said her heart rate was elevated, even though she was sitting down doing tele-work, and she has been taking anxiety medicine. She said she was still having breathing discomfort, clarifying she could not take a big enough breath. Patient will take a big breath, and will be good for a while, but then she needs to take another big breath. She said her doctor has checked her lungs, and her lungs were clear. She said she has to take multiple, deep breaths throughout the day. Patient's last blood work was in Oct2020. She said everything was good with her blood work. She said her hormones were good, but she had a Vitamin D deficiency. For treatment, patient stated that her primary care doctor prescribed Buspar 7.5mg, twice a day. She said the Buspar 7.5mg was dispensed in a pharmacy bottle and did not have the NCD, Lot, and Expiration Date. She said it will be 3 weeks from tomorrow (03Feb2021) she has been taking the Buspar 7.5mg and reported everyone seems to think she has anxiety, or she was crazy. Events did not require emergency room visit but patient visited physician office. There were no relevant tests. Outcome of muscles in her left arm were tender/aching, was not recovered, for axillary lymph nodes swelling and tender was recovered in 2021, for heart rate was elevated, Shortness of breath/breathing discomfort was recovering while for other events was unknown.
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| 35 | 2021-03-04 | weakness, dizziness |
Patient c/o weakness and feeling dizzy, EMT notified at 12:20, EMT assessed patient, VSS 157/93 HR 9...
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Patient c/o weakness and feeling dizzy, EMT notified at 12:20, EMT assessed patient, VSS 157/93 HR 97 RR 26 O2 98% BGM 129 at 1430. At 1440 146/95 HR 93 RR 18 O2 95%. EMT did not administer any medications, EKG Normal sinus. Fire department recommended patient to hospital as she was alone and driving herself. Fire department escorted patient to hospital via ambulance as a precaution at 1456.
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| 35 | 2021-03-04 | headache, fever, chills, fatigue, head discomfort |
severe swollen lymph nodes in left clavicle and left underarm; headache; burning/heat in eyes; fatig...
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severe swollen lymph nodes in left clavicle and left underarm; headache; burning/heat in eyes; fatigue / Third day had generalized fatigue; chills; fever; full body joint pain; nausea; muscle aches; heavy headed feeling; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 11:30 at a single dose for COVID-19 immunization. The first dose was received on 29Dec2020 (lot number: EL1284) on the left arm. Medical history included sulfa allergy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccine and did not had any other medications within 2 weeks of vaccination. On 19Jan2021 13:30, 2 hours after vaccine, patient developed headache and burning/heat in eyes and fatigue. On the first night (19Jan2021), she had chills, fever, full body joint pain, nausea, muscle aches and heavy headed feeling. Next morning on 20Jan2021, she had severe swollen lymph nodes in left clavicle and left underarm. Second night on 20Jan2021, patient had fever, chills, muscle aches. Third day on 21Jan2021, she had generalized fatigue and ongoing severe lymph node swelling. No treatment was received. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination. The reporter considered the events non-serious.
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| 35 | 2021-03-10 | dizziness |
lightheadedness/dizziness; Vaccine-Related Anxiety; This is a spontaneous report from a non-contacta...
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lightheadedness/dizziness; Vaccine-Related Anxiety; This is a spontaneous report from a non-contactable healthcare professional. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. During her 30-minute waiting period after the injection, the patient began to experience lightheadedness and dizziness. Treatment included water and snacks. Follow-up response to treatment was excellent. Patient discharged (pending clarification), she was stable to go home and follow-up with PCP. Differential diagnosis reported as vaccine-related anxiety (include misc mental health) and systemic reaction (hypoglycemia, hypotension, generalized rash). Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
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| 35 | 2021-03-10 | chills, weakness |
was going to pass out/Loss of consciousness; was going to pass out/Loss of consciousness/hx of passi...
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was going to pass out/Loss of consciousness; was going to pass out/Loss of consciousness/hx of passing out remote in distant past; started to feel very strange/No hearing or vision loss, just a general strange and uncomfortable feeling.; deep dreaming, then awoke feeling poorly; deep dreaming, then awoke feeling poorly; shaking; chills; BNT162B2 used in a Breastfeeding Mother; BNT162B2 used in a Breastfeeding Mother; This is a spontaneous report from a contactable physician (patient), this physician reported information for both mother and fetus/baby. This is the maternal report. Only this case is serious. A 35-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular into left arm on 05Feb2021 09:00 at single dose for COVID-19 immunization in workplace clinic. Medical history included hx of passing out remote in distant past. No allergies to medications, food, or other products. concomitant medications were none (no other medications the patient received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient previously took the first dose of BNT162B2 on unspecified date at single dose for covid-19 immunization. About 17 hours after vaccine, at 3am (06Feb2021 03:00), while up feeding her infant and sitting in a chair in the dark, she started to feel very strange, kind of like she was going to pass out (hx of passing out remote in distant past). No hearing or vision loss, just a general strange and uncomfortable feeling. Tried to call for help. Lost consciousness for a few seconds and had deep dreaming, then awoke feeling poorly. Set child back to bed, went to bed myself, had shaking chills for maybe 30 minutes following. No sweats, no normal symptoms related to vasovagal syncope. Just a general uncomfortable strange sensation as the prodrome. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the events. Patient was recovered from the events on unspecified date. It was reported as non-serious report. Seriousness criteria results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect were all no. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, the Company considers the reported event loss of consciousness recurrence is unrelated to BNT162B2 vaccine but more likely an inter-current medical condition in this subject with medical history of passing out remote in distant past. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021240721 mother/baby case
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| 35 | 2021-03-14 | fatigue, headache |
Sever pain and swelling in arm pit (size of an orange); Sever pain and swelling in arm pit (size of ...
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Sever pain and swelling in arm pit (size of an orange); Sever pain and swelling in arm pit (size of an orange); severe headache; neck and elbow pain; neck and elbow pain; tired; This is a spontaneous report from a contactable health professional reporting for herself. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EL9269, second dose (at the age of 35 years), via an unspecified route of administration in right arm on 08Feb2021 10:15 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2, Lot number EL9262, in right arm on 21Jan2021 (at the age of 35 years). COVID-19 vaccine was administered at hospital. Medical history included allergies to sulfa drugs. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC), diclofenac, venlafaxine hydrochloride (EFFEXOR), fluticasone propionate (FLONASE). On 09Feb2021 the patient experienced severe pain and swelling in arm pit, severe headache, neck and elbow pain, tired. The patient was not treated for the events. The events were non-serious with outcome of recovering.
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| 35 | 2021-03-15 | headache |
She received the 2nd Dose on 3/9/2021. On 3/10/2021 She complained of a headache. On the morning o...
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She received the 2nd Dose on 3/9/2021. On 3/10/2021 She complained of a headache. On the morning of 3/11/2021 she complained of abdominal pain and had no appetite. We then found her unresponsive, called 911 and the medics pronounced her at around 1300.
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| 36 | 2020-12-31 | headache |
patient had headache about 20 minutes after vaccination. No further interventions, patient does have...
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patient had headache about 20 minutes after vaccination. No further interventions, patient does have a history of migraines.
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| 36 | 2021-01-01 | fatigue | Fatigue that night and the following 36hrs |
| 36 | 2021-01-01 | dizziness |
Patient felt nauseated and dizzy; HR went from 48 (Normal for patient) up to 58 and remained at 58 u...
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Patient felt nauseated and dizzy; HR went from 48 (Normal for patient) up to 58 and remained at 58 until discharge; BP=80/42 and went up to 92/58 (normal for patient); patient given juice, water and crackers and stated she felt better; discharged with co-worker; alerted to contact ED with any excerbation of symptoms
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| 36 | 2021-01-01 | dizziness |
Received the COVID19 vaccine 2 weeks ago, and the next day started to have dizziness/lightheadedness...
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Received the COVID19 vaccine 2 weeks ago, and the next day started to have dizziness/lightheadedness and palpitations. It was the worst the first 2-3 days after the vaccine. It has improved somewhat, but is still not fully resolved and my improvement seems to have pleatued in the past few days. It is not debilitating nor a deterrent for me getting my 2nd dose, but I felt compelled to report my symptoms as I don't see dizziness and palpitations listed as a possible side effect.
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| 36 | 2021-01-01 | skin warm |
Tennis ball size hive that was itching and warm to the touch. This hive came and went 2-3 times over...
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Tennis ball size hive that was itching and warm to the touch. This hive came and went 2-3 times over the course of 1 week, each time it got bigger and hotter and more itchy.
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| 36 | 2021-01-02 | headache, fever | Fever. For 2 days Severe Body aches Headache |
| 36 | 2021-01-03 | fever, chills |
01/03/2020: Last night staff having chill and fever 101. Feeling better now. Covid test for her depa...
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01/03/2020: Last night staff having chill and fever 101. Feeling better now. Covid test for her department will be on 01/06/2021. No exposure. Already schedule 2nd dose appointment on 01/15/2021.
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| 36 | 2021-01-03 | nerve pain |
12/24/2020 swollen right side lymph nodes under arm; felt "on fire" reduced burning sensation over t...
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12/24/2020 swollen right side lymph nodes under arm; felt "on fire" reduced burning sensation over time. Then 1/1/2021 patient got weakness in bilateral arms, felt "rubbery" ; left arm and neck lymph nodes swollen 1/3/2021 was seen in ER for full body numbness, prickly heat, like waves of it. Bilateral arm weakness; nerves feel "on fire". vomiting x 1 50 mg of Benadryl taken approximately 9 pm on 1/3/2021.
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| 36 | 2021-01-03 | fatigue, weakness, chills, fever |
Delayed Moderate. temp 100.6-100.1, , nausea,chills, elevated Heart rate 110 muscle ache, fatigue, ...
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Delayed Moderate. temp 100.6-100.1, , nausea,chills, elevated Heart rate 110 muscle ache, fatigue, weakness
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| 36 | 2021-01-03 | skin warm |
Gold ball sized lump to left armpit near breast that was tender and warm to the touch. No prior issu...
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Gold ball sized lump to left armpit near breast that was tender and warm to the touch. No prior issues with armpit or breast tissue. Needed to take Motrin/Tylenol for pain and swelling for two days after vaccination.
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| 36 | 2021-01-03 | cold sweat, fever, sweating, malaise |
Injection received at 0815. At 0900 I started getting diaphoretic, clammy, nauseas and my face was f...
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Injection received at 0815. At 0900 I started getting diaphoretic, clammy, nauseas and my face was flushed. At 0930, I developed hives on my neck, chest and arms. I immediately went back to the vaccination site (I was still in the hospital at work) and was administered 25mg oral Benadryl and monitored for 30 minutes. The hives resolved, but I still felt unwell. At 1600 I noticed a swelling in my right upper thigh about the size of my hand. It was about 2 inches inferior to my inguinal crease and was the width of my thigh. It was mildly painful to the touch. My injection site was red, inflamed and itchy. I continued taking 25-50mg Benadryl Q4 and took 100 mg at night due to itchiness on my eyes, face, neck, chest and arms. This is still present, although less each day, as of Monday 1/4/21 morning. I have felt feverish but have not had a recorded fever. I took some Ibuprofen for the pain in my arm at the injection site. The redness, swelling and itchiness has decreased each day at the injection site, but is also still present as of Monday 1/4/21 morning. I still feel unwell and have continued diarrhea throughout the weekend.
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| 36 | 2021-01-03 | fatigue, headache |
Sunday started with severe headache and continued with mild body aches and feeling of just being tir...
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Sunday started with severe headache and continued with mild body aches and feeling of just being tired but didn't change my day much. Woke Monday morning at 4am to get ready for the work and the room was spinning. Off and on for the next 4 or so hours my blood pressure dropped and I had to lay back down. Even laying down had the room spinning. It has not been consistent and has improved as the day has gone but has yet to go away.
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| 36 | 2021-01-03 | body temperature increased, headache, cough, fatigue, runny nose |
Temp 100.4,dry cough, headache, body aches, fatigue, runny nose started 1-2-20 started dexamethasone...
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Temp 100.4,dry cough, headache, body aches, fatigue, runny nose started 1-2-20 started dexamethasone, zpack Pepcid vit c vit d zinc aspirin
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| 36 | 2021-01-04 | fever, nasopharyngitis, fatigue, shortness of breath, chills, runny nose |
12/23/2021 VACCINATION. ACHEY JOINTS, SORE AT INJECTION SITE, FEVER AND CHILLS AT 7PM. CONTACTED PC...
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12/23/2021 VACCINATION. ACHEY JOINTS, SORE AT INJECTION SITE, FEVER AND CHILLS AT 7PM. CONTACTED PCP TO SEE IF CAN TAKE IBUPROFREN. CALLED COVID HOTLINE AND THEY REFERRED ME TO CALL MY PCP. 12/24/20210INJECTION SITE SEVERE PAIN, COULDN'T MOVE ARM. 'FELT LIKE STABBING WITH A KNIFE', SOB, AND FEVER AND CHILLS 12/25/2020 COLD SYMPTOMS AND FEVER 12/26/ COLD SYMPTOMS, RUNNY NOSE, FEVER, FATIGUE 12/27/2020 FEVER, SOB, ACHY JOINTS; MILDER SYMPTOMS 12/28/2020 STARTED TO FEEL BETTER
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| 36 | 2021-01-04 | dizziness, fatigue |
Angioedema of lips, throat, eyes, hands. Flushing of hands; Angioedema of lips, throat, eyes, hands...
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Angioedema of lips, throat, eyes, hands. Flushing of hands; Angioedema of lips, throat, eyes, hands. Flushing of hands; Dizziness; Fatigue; Legs became heavy; Joint stiffness of hands; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ 1685), intramuscular on the left arm on 23Dec2020 at 06:30 AM in a hospital at a single dose for COVID-19 immunization. Medical history included known allergies of seasonal allergies, cats, and metals; migraines, chronic idiopathic urticaria, and angioedema. The patient was not pregnant and did not have any other vaccine in four weeks. The patient did not have COVID prior to the vaccination and did not test positive to COVID post vaccination (also reported as not been tested for COVID-19 after the vaccination). Concomitant medication included propranolol, cetirizine hydrochloride (ZYRTEC), and sertraline (reported as other medications in two weeks). On 23Dec2020 at 06:45 AM, the patient experienced immediate symptoms of angioedema of lips, throat, eyes, hands; flushing of hands, dizziness, fatigue, legs became heavy, and joint stiffness of hands. She was monitored by colleagues for an hour, prescription for Epi pen refilled, and available angioedema and fatigue persisted for three days. It was reported that the patient was not treated for the adverse events but it was also reported that the AE treatment also included X-ray and antibiotic. Outcome of the events was recovered in Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of immediate symptoms of angioedema of lips, throat, eyes, hands, flushing of hands, dizziness, fatigue, legs became heavy, and joint stiffness of hands cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 36 | 2021-01-04 | weakness |
Begin with localized tenderness and pain at injection site. Progressed to joint pain in the arm, los...
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Begin with localized tenderness and pain at injection site. Progressed to joint pain in the arm, loss of strength, tenderness and inability to move arm.
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| 36 | 2021-01-04 | dizziness | Complained of feeling lightheaded and dizzy |
| 36 | 2021-01-04 | fever | Fever = 101.6F |
| 36 | 2021-01-04 | fever | Fever Body aches |
| 36 | 2021-01-04 | throat pain |
I just developed a very sore throat; This is a spontaneous report from a contactable nurse (patient ...
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I just developed a very sore throat; This is a spontaneous report from a contactable nurse (patient herself). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 28Dec2020 at a single dose for COVID-19 immunisation. Medical history was none. Concomitant medications included multivitamins (unspecified). The patient just developed a very sore throat on 29Dec2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was unknown. Information about lot/batch number has been requested.
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| 36 | 2021-01-04 | malaise, dizziness, head discomfort, headache |
I worked the night of 18th and 19th (night shift nurse) - night of 18th - arm very sore (dominant ...
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I worked the night of 18th and 19th (night shift nurse) - night of 18th - arm very sore (dominant arm where shot was taken) by end of night arm was sore; continued for several days. (Got my period either the night of 18th or morning of 19th). About 36 hours after vaccine; stood up to attend an alarm and felt very ill at patient's bedside and had to sit down: nauseous (felt similar to co-vid) - took Motrin an hour later; the day of 20th - slept all day; 21st - no appetite; mild headache - nauseous - period at same time of vaccine; 22nd - felt bleh; didn't eat much food - period going away but I was feeling worse; feel like I have the return of internal vibrations (can sit in my hands when I'm trying to do something for a patient that needs done quickly) back in July when I had Co-Vid (when I was out of work out of month - and had to see a cardiologist - two months until normal (neural and cardiac symptoms that went away with time) - so was returning of buzzing/etc. 23rd: could feel like I had internal vibrations sensations; nauseous - increased - got a refill from an old dental prescription - started Zofran; headache pressure (head pressure); a vertigo-ish feeling - felt like I just walked off a boat; at that point - called out of work - COVID hotline hospital call - did a rapid test that was negative (on 24th) and on 24th: had still all the same symptoms - nausea was worse and felt a bit more dizzy occasionally and called out of work again but could take care of myself (laid around) - " it felt like baby covid" 25th - work wanted me to get tested again; 26th - Panther Co-vid test - which was also negative. 27th and 28th - dizziness better; still taking Zofran one time /day (for nausea); was able to go to work on 29th - still had some nausea but didn't have to lie down all day anymore - still had internal vibrations - feels like I should be having a tremor but can't see it externally; 30th finally able to see primary care Dr and she ordered lab work: Dr wasn't certain it was an adverse effect vs. me feeling my own immune response to spike protein; Initial covid symptoms in July were similar to this; and she will see how things go; SED Rate was 1 so not concerning; CBC was fine and B12 was fine. Not much as changed since then: returned to work; can go about things in every day; stopped taking Zofran on 31st; I still had nausea but it was mild enough that I didn't need to take it and Dr said it would be best to stop due to it's on effects. Yesterday, was first day with no nausea (1/4/2021); still have internal vibrations sensation but it has gone down quite a bit - now more of a mild buzzing electric current sensation - like insides are buzzing super fast ; when I noticed when not occupied with other things which is how it faded out with original illness.
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| 36 | 2021-01-04 | sweating, headache |
Pt reports tingling and sweating to R side of the body (face, arm, and leg). Reports HA R side of b...
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Pt reports tingling and sweating to R side of the body (face, arm, and leg). Reports HA R side of body. As evening progressed, patient reports worsening HA and vomiting. Pt reports pain in R arm and swelling in armpit area. Reports s/s resolved the next day. Recommended f/u with PCP.
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| 36 | 2021-01-04 | shortness of breath |
Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swel...
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Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; This is a spontaneous report from a contactable other HCP. This 36-year-old female other HCP reported for herself that that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular at right arm at single dose for COVID-19 immunisation on 22Dec202008:00 AM. Relevant history included Endometriosis and allergies with Keflex, Levsin. Concomitant drug included bupropion SR which received within 2 weeks of vaccination. The patient experienced shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of neck 4 days after vaccine. Tightness on chest was gradually improving but comes and goes daily for the past week. The events was considered as non-serious. No treatment was received. The outcome of events was reported as recovered with lasting effects. The patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient been tested for COVID-19 with negative result per Nasal Swab on 23Dec2020. Information on the lot/batch number has been requested.
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| 36 | 2021-01-04 | fever |
Vommiting, Body aches, Fever of 102; Vommiting, Body aches, Fever of 102; Vommiting, Body aches, Fev...
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Vommiting, Body aches, Fever of 102; Vommiting, Body aches, Fever of 102; Vommiting, Body aches, Fever of 102; This is a spontaneous report from a contactable other healthcare professional, the patient. A 36 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown), via intramuscular route of administration in the left arm on 28Dec2020 at 08:00 AM (at the age of 36-years-old) as a single dose for COVID-19 vaccination. The patient had no relevant medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 28Dec2020, the patient experienced vomiting, body aches and fever of 102. The report was reported as non-serious. The patient was not treated for vomiting, body aches and fever of 102. The clinical outcome of vomiting, body aches and fever of 102 was recovered on an unknown date. It was also reported that since the vaccination, the patient had been tested for COVID-19 (rapid test nasal swab) on 31Dec2020 and was negative. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
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| 36 | 2021-01-04 | headache, runny nose | rhinorrhea, headache, tested for COVID-19 on 1/04/2021 and was Positive |
| 36 | 2021-01-04 | runny nose |
runny nose that had bloody discharge; runny nose that had bloody discharge; The mother was 23 weeks ...
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runny nose that had bloody discharge; runny nose that had bloody discharge; The mother was 23 weeks pregnant at the onset of the event; pregnancy; pregnancy; This is a spontaneous report from a non-contactable physician (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Not available/provided to reporter at the time of report completion) via an unspecified route of administration on 26Dec2020 13:30 on right arm at a single dose for COVID-19 immunization. The patient was allergies for adhesives. The patient is pregnant at the time of vaccination. The mother was 23 weeks pregnant at the onset of the event. The mother was due to deliver on 23Apr2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included acetylsalicylic acid (ASPIRIN 81) at 81mg. The patient experienced runny nose that had bloody discharge on 27Dec2020. No treatment received for the event. The outcome of the event was recovered in Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 36 | 2021-01-04 | weakness, lethargy |
starting to feel lethargic and weak. Had menses with increased blessed. Called physician to have b...
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starting to feel lethargic and weak. Had menses with increased blessed. Called physician to have blood work done to see if I was experiencing anemia. Blood work complete on 12/31/2020. On 1/3/2021, I woke up with blood blisters all over the inside of my mouth and petechia on my trunk and bilateral upper and lower extremities. I called my primary physician to report the symptoms. He suggested to go to the ER if my symptoms worsened. Later that evening I started with a nose bleed and did go to the ER. Upon arrival to the ER, my platelet count was 9. I was admitted to the hospital and diagnosed with ITP.
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| 36 | 2021-01-04 | headache |
woke up with a slight headache; she felt her whole arm was sore; slight soreness at the injection si...
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woke up with a slight headache; she felt her whole arm was sore; slight soreness at the injection site; felt some warmness right after the vaccine, like she felt kind of high; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular at deltoid left on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history included ongoing high blood pressure. Concomitant medication included hydrochlorothiazide/losartan (strength: 25mg/320mg, formulation: tablet), oral one dose form from an unknown date and ongoing, once a day for blood pressure high. The patient previously took flu vaccine for immunization and experienced soreness in her arm and generally felt tired throughout that week. The patient reported that on 23Dec2020 she felt some warmness right after the vaccine, like she felt kind of high (she doesn't know if it was just nerves with this being a new vaccine) and slight soreness at the injection site, on 23Dec2020 at 19:00 she felt her whole arm was sore and on 24Dec2020 she woke up with headache. The patient outcome of the events was unknown.
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| 36 | 2021-01-05 | fatigue |
"About 2 hours after vaccine administration experienced severe fatigue. Went home and took 2 hour na...
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"About 2 hours after vaccine administration experienced severe fatigue. Went home and took 2 hour nap. Was still somewhat fatigued through the evening. Felt fine when waking up the next day."
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| 36 | 2021-01-05 | shortness of breath |
12/26/2020: Nausea, vomiting, diarrhea for 24 hours 12/29/2020: shortness of breath, chest tightness...
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12/26/2020: Nausea, vomiting, diarrhea for 24 hours 12/29/2020: shortness of breath, chest tightness for 36 hours. Went to ER. COVID and flu tests done. Both negative.
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| 36 | 2021-01-05 | lethargy, dizziness |
40 seconds after shot: tingling in left arm and left hand with then wooziness. Tingling itching s...
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40 seconds after shot: tingling in left arm and left hand with then wooziness. Tingling itching sensation and mind pain in left arm and hand continued for a few hours then spread into left leg which continued into the next day. Moderate left shoulder tenderness 6 hours after shot lasting 2 days. 6 days after shot severe lethargy, body aches and brain fog which is current on 01/06/21.
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| 36 | 2021-01-05 | dizziness | Chest pain, dizziness, lightheadedness |
| 36 | 2021-01-05 | dizziness | Dizziness Narrative: Dizzy approximately 2-3 minutes after vaccine injection |
| 36 | 2021-01-05 | fatigue |
Employee received Pfizer COVID-19 vaccine on 12/23/2020. Waited 15 minutes after immunization and f...
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Employee received Pfizer COVID-19 vaccine on 12/23/2020. Waited 15 minutes after immunization and felt fine. Started to have a hot flash on the way home. Then her tongue felt sluggish but not swollen. She had a few minutes having difficulty swallowing but denies a sensation of throat swelling. Arm became sore and heavy but no redness. Drove back to the hospital with the onset of these symptoms and waited in the parking lot for 15 minutes to see if the symptoms were going to progress but they didn't. Stated she became very fatigues for a few hours but felt fine the next day except for a sore arm.
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| 36 | 2021-01-05 | malaise, headache, fatigue, fever |
Fever 100.0; severe headache; malaise; fatigue; This is a spontaneous report from a contactable phar...
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Fever 100.0; severe headache; malaise; fatigue; This is a spontaneous report from a contactable pharmacist (the patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730), intramuscularly in the left arm on 22Dec2020 at 09:30 (at the age of 36-years-old) as a single dose for COVID-19 immunization. Medical history included multiple sclerosis. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: ergocalciferol (VITAMIN D), natalizumab, and topiramate, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Dec2020 at 09:00, the patient experienced fever 100.0, severe headache, malaise, and fatigue post injection. No treatment was given for these events. The clinical outcome of fever 100.0, severe headache, malaise, and fatigue post injection was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 36 | 2021-01-05 | headache, fever, chills | Fever started around noon with body aches , chills, and a headache |
| 36 | 2021-01-05 | headache, fatigue, fever, chills |
Fever; Injection site pain; Heart rate up; Body aches; Headache/Head face pounding; Chills; Tired; T...
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Fever; Injection site pain; Heart rate up; Body aches; Headache/Head face pounding; Chills; Tired; This is a spontaneous report from a contactable other HCP (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EK5730) intramuscularly at left arm on 30Dec2020 at 12:15 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history included environmental allergies only. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced fever, head face pounding, heart rate up, body aches, headache, chills, tired, injection site pain; on 30Dec2020 at 06:00 PM. The events were non-serious. No treatment received for events. The outcome of events was not recovered. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 36 | 2021-01-05 | throat pain, headache, nasal congestion, productive cough |
I have body ache; clear nasal drainage; Nasal congestion; headache; moist cough; sneezing; watery ey...
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I have body ache; clear nasal drainage; Nasal congestion; headache; moist cough; sneezing; watery eyes; sore throat; This is a spontaneous report from a contactable nurse (patient herself). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (left arm), on 29Dec2020 at 15:15, at a single dose, for COVID-19 immunization. Relevant medical history included fibromyalgia. The patient has no known allergies. Concomitant medications included an unspecified multivitamin, cyclobenzaprine, methylphenidate, sertraline and ibuprofen. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with COVID prior vaccination. The vaccine was administered in a nursing home/senior living facility. On 01Jan2021, at 8:00 a.m., the patient experienced body ache, clear nasal drainage, nasal congestion, headache, moist cough, sneezing, watery eyes, and sore throat. The patient did not receive treatment for the events. The patient has not yet recovered from the events. The patient had a negative post vaccination polymerase chain reaction (PCR)/ nasal swab on 02Jan2021. Information on the lot/batch number has been requested.
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| 36 | 2021-01-05 | fatigue |
I recieved my injection at 1:00pm. My arm became sore around 3:30pm as expected. I became very ti...
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I recieved my injection at 1:00pm. My arm became sore around 3:30pm as expected. I became very tired around 5pm. Around 6:30 I experience heat on the left side of my neck up to the back of my left ear. Also tingling, mild swelling, and drooping on left side of face that lasted a couple of hours. The next day I still experienced the heat feeling in left side of neck up to the back of left ear, fatigue, and soreness in arm. But by 3pm I felt fine and haven't had any problems since.
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| 36 | 2021-01-05 | migraine |
I suffered an ocular migraine 5 days post vaccine. Never had one before. Very scary. Zigzag spot in ...
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I suffered an ocular migraine 5 days post vaccine. Never had one before. Very scary. Zigzag spot in both fields of visions for 10 minutes followed by kaleidoscope vision in the left field for 5 mins. No headache after.
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| 36 | 2021-01-05 | headache, throat pain, night sweats |
Nausea, headache, diarrhea, nightsweats, sore throat and swollen lymph notes causing difficulty swal...
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Nausea, headache, diarrhea, nightsweats, sore throat and swollen lymph notes causing difficulty swallowing x 2 days (took ibuprofen) Multiple fever blister outbreaks since receiving vaccine
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| 36 | 2021-01-05 | chills, fatigue, headache, throat pain, fever |
On 1/6 at approximately 9am hour, I noticed joint pain in my fingers while typing, muscle soreness i...
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On 1/6 at approximately 9am hour, I noticed joint pain in my fingers while typing, muscle soreness in my upper back, a headache, and a slightly sore throat. It quickly went down hill with a fever, chills, worsening joint and muscle pain everywhere, nausea, severe fatigue, worsening sore throat, tingling and numbness in all extremities at random locations. It is now 3pm, about 21 hours since vaccination-fever has broken once (I took ibuprofen at 2pm) but returned but not as high, and severe headache with light sensitivity. The joint pain and numbness has faded but I am left with severe muscle soreness, like I was in a car accident. Oh and I lost taste sometime today. Also I had injection site pain for both doses, starting the morning after.
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| 36 | 2021-01-05 | fatigue, weakness |
Per patient: "I recieved the covid vaccine on 12/29/2020. Ten minutes later I broke out in a rash fr...
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Per patient: "I recieved the covid vaccine on 12/29/2020. Ten minutes later I broke out in a rash from chest down it was a burning and itching and red spots. They took me to ER and gave me medicine. Within 40 mins I felt better so I left to go home. I have been feeling really tired and weak. I went home on the 4th with weakness and I did vomit 1 time. I felt sick to my stomach all day. I came back to work today still feeling nausiated."
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| 36 | 2021-01-05 | throat irritation, throat swelling |
Received the Pfizer vaccine at 3:18pm, 20 minutes later reported itchy throat and nose. Reported 3/1...
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Received the Pfizer vaccine at 3:18pm, 20 minutes later reported itchy throat and nose. Reported 3/10 severity of symptoms. Patient reported mild swelling of throat 5 minutes later. When reassessed her symptoms were the same, no signs of angioedema, no coughing. Patient able to talk with no difficulty, denies shortness of breath and chest tightness, patient was able to drink and swallow without much difficulty. Patient continued to complain of symptoms and requested IM Benadryl. Reported her partner would be picking her up and take her home. Vital signs were taken prior to Benadryl administration and were: BP 108/71, HR 69, O2 99% RA at 4:15pm. Benadryl 25mg IM administered to right deltoid at 4:21pm. Vital signs taken after administration were: BP 105/69, HR 72, O2 99% RA at 4:31pm. Declined ED, states she is feeling better. Patient was escorted by RN to partner's car; she was ambulating and declined the wheelchair.
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| 36 | 2021-01-05 | fatigue |
Severe insomnia. Started the night of 1/1/2021. Was unable to fall asleep despite being tired. Th...
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Severe insomnia. Started the night of 1/1/2021. Was unable to fall asleep despite being tired. This is not normal for me. This has continued every night. I am unable to fall asleep despite being exhausted. Once asleep I am waking up within an hour and a half to two hours and not able to go back to sleep. Over the past 5 nights I have averaged 2 hours a sleep night and no day time naps.
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| 36 | 2021-01-05 | sweating, pneumonia, productive cough, fever, fatigue, chills, dizziness, headache |
The day after the vaccine I had fatigue and body aches. Then on 12-23 fevers of 101.4, chills, body ...
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The day after the vaccine I had fatigue and body aches. Then on 12-23 fevers of 101.4, chills, body aches, diarrhea, vomiting, productive cough, and profuse sweating. Jan 1st I was in the shower and was dizzy with a headache. Loss of consciousness almost happened and that is when i got out of the shower and laid down. Went to the ED and was diagnosed with bilateral pneumonia
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| 36 | 2021-01-05 | chills, throat pain, fever, headache |
Usual sore arm and headache right after the vaccine, followed by body aches, fevers, chills, joint p...
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Usual sore arm and headache right after the vaccine, followed by body aches, fevers, chills, joint pains, sore throat, cough, swollen lymph nodes, and now a facial rash.
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| 36 | 2021-01-05 | chills, fever |
intermittent fever; diarrhea; chills; nausea; This is spontaneous report from a non-contactable othe...
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intermittent fever; diarrhea; chills; nausea; This is spontaneous report from a non-contactable other health professional. An adult female patient (occupation: Nurse, not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), intramuscularly at the age of 36-year-old (age at the time of vaccination) on 28Dec2020 at single dose at left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 2 days later (30Dec2020): diarrhea, chills, nausea, intermittent fever. The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was unknown. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
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| 36 | 2021-01-06 | dizziness, headache |
36F w/ Hx of HTN w/ HA and dizziness following COVID vaccine dose today. Symptoms began about 7 min...
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36F w/ Hx of HTN w/ HA and dizziness following COVID vaccine dose today. Symptoms began about 7 minutes post vaccination, no airway complaints, vomiting/nausea/abdominal pain, no chest pain, wheezing or SOB, no rash. VS wnl throughout course of observation in vaccine POD. Airway intact, no stridor, no signs of respiratory distress. Given PO fluids. Symptoms persisted resulting in transfer to Emergency Department for further evaluation and monitoring. Did not require additional interventions or any medications while in vaccine POD.
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| 36 | 2021-01-06 | fever, chills |
About 24 hours after receiving the vaccine, I had a fever of 100.4 and chills. This lasted for about...
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About 24 hours after receiving the vaccine, I had a fever of 100.4 and chills. This lasted for about 6 hours before bed. I woke up in the morning and the fever and chills were gone. I feel like this was a normal immune response but my employer asked me to fill this out.
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| 36 | 2021-01-06 | fever, headache, chills |
C/o aches, chills, headache and fever that began the next morning at 6:00 am after receiving the va...
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C/o aches, chills, headache and fever that began the next morning at 6:00 am after receiving the vaccine. Treatment include Advil.
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| 36 | 2021-01-06 | headache, fever |
Fever 101.3 with severe body aches and terrible headache since last night until now. It has been mo...
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Fever 101.3 with severe body aches and terrible headache since last night until now. It has been more than 24hrs since I received a vaccine.
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| 36 | 2021-01-06 | chills, fever | Fever, chills, arthralgias |
| 36 | 2021-01-06 | chills, headache |
Got vaccine at 1100am Starting at about 1100pm, I developed shaking chills, myalgia, Frontal Headac...
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Got vaccine at 1100am Starting at about 1100pm, I developed shaking chills, myalgia, Frontal Headache, nausea. I had redness and soreness at site of injection. Symptoms resolved within 24hrs with help from Tylenol.
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| 36 | 2021-01-06 | shortness of breath | Hives, itching, wheezing, tachycardia, high b/p, difficulty breathing |
| 36 | 2021-01-06 | fatigue, dizziness, headache |
Immediately after injection, I felt a warm feeling flow from the injection site and across my chest....
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Immediately after injection, I felt a warm feeling flow from the injection site and across my chest. No shortness of breath or chest pain. Felt slightly light-headed. Drank water and ate some food to closely monitor. Very sore Left deltoid starting about 8 PM on 12/31/20 (same day as the vaccine administration). It was so sore that it woke me up a few times at night and 1/1/21 I had to take Ibuprofen 400 mg to alleviate the pain. Had a dull headache all day 1/1/21 and very tired. Slept that night from 9 pm - 8 am next day. No symptoms since 1/3/21.
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| 36 | 2021-01-06 | dizziness |
Lightheadedness, chest pain/pressure, flushed skin of chest, tingling BLE > BUE. Taken to ED from v...
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Lightheadedness, chest pain/pressure, flushed skin of chest, tingling BLE > BUE. Taken to ED from vax site. Improved but still with lightheadedness and rash of upper chest. Given IVF and benadryl injx. Observation x 3 hours.
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| 36 | 2021-01-06 | headache, fatigue |
Pfizer-BioNTech COVID-19 Vaccine EUA After receiving the vaccine developed symptoms later that eveni...
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Pfizer-BioNTech COVID-19 Vaccine EUA After receiving the vaccine developed symptoms later that evening, fatigue, muscle aches (nighttime only) and headache that was relieved with Tylenol .
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| 36 | 2021-01-06 | shortness of breath |
Shortly after the patient was administered a first dose of Covid-19 vaccine at around 3:05 pm on 1/0...
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Shortly after the patient was administered a first dose of Covid-19 vaccine at around 3:05 pm on 1/07/21, the patient experienced troubled breathing, chest tightness and wheezing for several minutes. The patient described her condition as, "my throat feels like it is closing up." An epipen was given at 3:12 pm and the patient reported improvements at 3:16 pm (four minutes after the epipen was given). Emergency services was called and reported to the scene at 3:12 pm where they noted the patients improved condition, after the epipen was administered.
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| 36 | 2021-01-06 | fatigue, sweating, headache |
Tachycardia, diaphoresis, headache, neck pain, muscle aches, fatigue. Everything but fatigue lasted ...
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Tachycardia, diaphoresis, headache, neck pain, muscle aches, fatigue. Everything but fatigue lasted approx 12 hours, fatigue about 4 days.
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| 36 | 2021-01-06 | headache, fever, chills | fever 99.7F, chills headache |
| 36 | 2021-01-07 | headache, throat pain, malaise |
- Almost immediate onset of nausea, sore throat, headache, and sensation of fast heart rate; along w...
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- Almost immediate onset of nausea, sore throat, headache, and sensation of fast heart rate; along with feelings of mild illness (like a cold) and arm pain which is consistent with other vaccination response. - Waited at clinic for 30 minutes as directed due to previous history of anaphylaxis to injected meds (among others). Reported feeling poorly to nurse monitoring people waiting at 30 minute mark, who encouraged waiting longer but did no further assessment. Waited another 15 minutes with no resolution or improvement. Decided to leave and monitoring staff said they could not keep patients if they wanted to leave. - Approximately 15 minutes later (1hr after injection), took one 25mg Benadryl liquid gel as nausea/headache/fast heart rate were consistent with prior allergic reaction and not with prior vaccine response. Those symptoms resolved after 1-2 hours; the feeling of mild illness lingered for approx. 3 days more.
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| 36 | 2021-01-07 | headache |
1/4/21: Severe headache, not relieved with OTC meds or prescription migraine meds. 1/7/21: itchy ras...
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1/4/21: Severe headache, not relieved with OTC meds or prescription migraine meds. 1/7/21: itchy rash/hives on arm, legs, back and under chin. One dose of Benadryl at that time with no relief.
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| 36 | 2021-01-07 | respiratory tract congestion, shortness of breath |
12/23/2020 I started expecting the congestion on 12/25/2020 I lost taste and smell & I felt out of ...
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12/23/2020 I started expecting the congestion on 12/25/2020 I lost taste and smell & I felt out of breath and also had diarrhea. 12/26/2020 a doctor called me I express my symptoms he ordered a test for covid & I tested positive. On Saturday 01/02/2020 visited the ER to get help to breath
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| 36 | 2021-01-07 | shortness of breath |
Approx 10-15 min post-vaccine, pt began to c/o flushing and bilat feet numbness/tingling. NIBP 172/9...
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Approx 10-15 min post-vaccine, pt began to c/o flushing and bilat feet numbness/tingling. NIBP 172/90, HR 90s. No SOB, hypoxia. Benadryl 50 IM given @ 1756. Pt discharged from vaccine clinic to ED. NIBP 157/111, HR 102 @ time of discharge.
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| 36 | 2021-01-07 | cough, shortness of breath, migraine |
Around 10:30pm I felt like my throat was closing and I was choking; Around 10:30pm I felt like my th...
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Around 10:30pm I felt like my throat was closing and I was choking; Around 10:30pm I felt like my throat was closing and I was choking; I had chest pain, chest tightness; I had chest pain, chest tightness; Very SOB at rest; Throughout the day I was cough and my face started flushing so I tool Benadryl/severe facial flushing; On 23Dec I got nerve blocks for my migraines.; Throughout the day I was cough and my face started flushing so I tool Benadryl.; This is a spontaneous report from a contactable nurse who reported for herself. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730) dose number 1, via an unspecified route of administration on 19Dec2020 11:30 at single dose for COVID-19 immunization. Medical history included von willebrand's disease, narcolepsy with cataplexy, IIH (Idiopathic intracranial hypertension), HTN (hypertension), GERD (gastrooesophageal reflux disease), migraines. Patient also had known allergies: PCN (penicillin), shellfish, IV contrast, cefdinir and bees. On 23Dec2020, patient got nerve blocks for her migraines. Throughout the day patient was cough and her face started flushing so she tooled diphenhydramine hydrochloride (BENADRYL). Around 22:30, patient felt like her throat was closing and she was choking. She had chest pain, chest tightness. EMS (emergency medical services) was called and patient was brought to the hospital. On 25Dec2020, patient felt like her throat was closing, like someone was sitting on her chest and chest tightness still with chest pain. Very SOB (shortness of breath) at rest. Patient went to the ER (emergency room) and received IV dexamethasone (DECADRON) and diphenhydramine hydrochloride. On 26Dec2020, patient had the same symptoms but with severe facial flushing and patient went back to the ER and was given IV dexamethasone. Patient was sent home on a maximum amount of medications. I had seen her primary care, ENT (ear nose throat centre), Allergy, ID (infectious disease), and pulmonology. Her CT (computerised tomogram) of chest on 25Dec2020 was negative along with her COVID test. Patient SOB on rest and exertion still. Onset date of the adverse events was reported as 23Dec2020, 22:30. Patient received treatment for the events included multiple medications and high dose prednisone. Lab data on 25Dec2020 included CT of chest: negative, influenza type A/B combo: negative, Covid 19: negative and nasal swab: negative. Action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. The clinical presentation of the events is suggestive of possible allergic reactions. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 36 | 2021-01-07 | chills, fever |
Chills, rigors, fever to 102F, headache, myalgias. All began around 7pm, persisted throughout night,...
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Chills, rigors, fever to 102F, headache, myalgias. All began around 7pm, persisted throughout night, fever broke at ~5am.
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| 36 | 2021-01-07 | shortness of breath, fatigue | Fatigue, tired, muscle weakness, trouble breathing, pain in site of injection, clouded mind |
| 36 | 2021-01-07 | fever, headache, dizziness, chills |
Fever of 102.6 F for 6 hours, fever of 100.4 or greater for at least 24 hours; light headed; numbnes...
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Fever of 102.6 F for 6 hours, fever of 100.4 or greater for at least 24 hours; light headed; numbness in left hand and fingers from arm swelling; numbness in left hand and fingers from arm swelling; nausea; chills; headache; body aches; joint pain; first dose on 16Dec2020 10:15, second dose on 04Jan2021 11:45; This is a spontaneous report from a contactable other health professional (patient). A 36-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, first dose on 16Dec2020 10:15, second dose on 04Jan2021 11:45 (lot number EJ1685), both on left arm at single dose for COVID-19 immunization. Medical history included known allergies Sulfa. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient experienced Fever of 102.6 F for 6 hours, fever of 100.4 or greater for at least 24 hours, light headed, numbness in left hand and fingers from arm swelling, nausea, chills, headache, body aches and joint pain on 04Jan2021 14:30. Patient received Acetaminophen and ibuprofen for treatment. The outcome of the events was not recovered.
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| 36 | 2021-01-07 | chills, fever |
Fever, chills, body aches and pain at the injection. Treatment is Tylenol. Patient will continue to...
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Fever, chills, body aches and pain at the injection. Treatment is Tylenol. Patient will continue to monitor
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| 36 | 2021-01-07 | headache | Heart palpitations, headache, body aches for 48 hours after receiving shot |
| 36 | 2021-01-07 | fever | Initial fever of 101.6F, now resolved |
| 36 | 2021-01-07 | shortness of breath, dizziness, malaise |
Patient had her first dose of the COVID vaccine and was waiting in the lobby when she asked another ...
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Patient had her first dose of the COVID vaccine and was waiting in the lobby when she asked another patient to get help. When staff arrived she was grey, dizzy, having difficulty breathing with rapid respirations and overall not feeling well. Pulse Ox was 88 on room air so she was placed on oxygen and the EpiPen was used. EMS was called. She began improving with the oxygen and after the 0.3mg of Epi. EMS transported her to the ER and at her request her boyfriend was notified.
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| 36 | 2021-01-07 | dizziness, runny nose, headache |
Patient started having severe dizziness, with a racing pulse. Pt stated she felt very warm. Given ...
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Patient started having severe dizziness, with a racing pulse. Pt stated she felt very warm. Given ice pack and cold cloths. BP was slightly elevated. Pulse initially was about 112. Had patient lay down and she felt better. Thought to be vasovagal response. Starting at 01:30 on 1/7/21 she had a severe headaches, eyes watering, runny nose, dry throat. Injection site reaction
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| 36 | 2021-01-07 | dizziness, fatigue |
Pfizer-BioNTech COVID-19Vaccine EUA I received my shot on 01/06/2021 at 0830 a few minutes after rec...
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Pfizer-BioNTech COVID-19Vaccine EUA I received my shot on 01/06/2021 at 0830 a few minutes after receiving the vaccine I became dizzy and lightheaded. I let the nurse in the observation area know and honestly didn't think much of it. It lasted about a minute or two. I was fine for several hours after just experienced the normal soreness and kind of achy tired feeling. Around 1700 I began to itch, my whole right arm and upper torso area was itchy. I did not take any medications for this and it subsided around 2000.
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| 36 | 2021-01-07 | chills, fever | Running a fever of 100.7 Chills |
| 36 | 2021-01-07 | throat irritation |
Tingling/Hot burning throat/tachycardia and chest tightness. Presented to ED. Given diphenhydramine...
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Tingling/Hot burning throat/tachycardia and chest tightness. Presented to ED. Given diphenhydramine. Observed and discharged.
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| 36 | 2021-01-07 | fever, headache |
headache; arm soreness for 3 days; fever and back pain that began Thursday; fever and back pain that...
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headache; arm soreness for 3 days; fever and back pain that began Thursday; fever and back pain that began Thursday; nausea; body aches for 2 weeks; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 (at the age of 36-years-old) as a single dose for COVID-19 vaccination. Medical history was not reported. The patient's concomitant medications were not reported. On an unknown date the patient experienced headache, arm soreness, body aches for 2 weeks, fever, back pain and nausea. The patient reported feeling absolutely horrible, which felt like it is escalating sometimes per patient. The patient stated that it was initially just arm soreness for 3 days then all other symptoms including fever and back pain that began Thursday (date unknown), and now a headache, per the patient "before it was just soreness, body aches for 2 weeks, nausea". The patient is completing daily check-ins on the website name. She has a copy of the Fact Sheet for Recipients and Caregivers. The clinical outcome of the headache, arm soreness for 3 days, fever, back pain, nausea and body aches for 2 weeks was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 36 | 2021-01-07 | headache, chills, fever, cough |
sore arm immediately. then 10 hours after the shot, chills, headache, and back pain followed by feve...
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sore arm immediately. then 10 hours after the shot, chills, headache, and back pain followed by fever up to 104.7, abdominal pain, nausea and vomiting, myalgia, and cough.
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| 36 | 2021-01-07 | fatigue, chills | soreness at injection site, fatigue, chills, body aches, joint pain |
| 36 | 2021-01-07 | nerve pain, headache |
vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; ...
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vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; It appears I have eye shadow; peeling/dryness of skin around lips; peeling/dryness of skin around lips/It appears I have eye shadow but peeling is not visible; burning and itch of lip region; burning and itch of lip region; muscle spasm; Neuralgia; medium-severe headache; nausea; sensitive to light; mild confusion; lack of concentration; This is a spontaneous report from a contactable nurse (patient herself). A 36-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), intramuscular in 28Dec2020 08:30 at a single dose in the left arm as COVID vaccine. Medical history included history of Grave's disease at age 19 which has resolved without medication for many years. The patient had no known allergies: no allergies to medications, food, or other products. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient had no other vaccine in four weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not taking any daily medications. On 28Dec2020 (day 1), patient had no significant symptoms. On 29Dec2020 (day 2), patient had medium-severe headache, nausea, sensitive to light, mild confusion and lack of concentration. On 30Dec2020 (day 3), patient had muscle spasm that wake from a sound sleep in biceps tendon region, and neuralgia in left upper and lower extremities. On 31Dec2020 (day 4), patient had peeling/dryness of skin around lips, burning and itch of lip region. On 01Jan2021 (day 5), patient had post vaccination burning, itching redness to eye lids. Patient realized patient should photo her journey. It appeared patient have eye shadow but peeling was not visible due to moisturizer and bacitracin "ito" try and sooth the pain. Patient can send at additional request since patient can't upload. The patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of the event "peeling/dryness of skin around lips/it appeared patient have eye shadow but peeling was not visible". No treatment received in response to the other events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The outcome of the events medium-severe headache, nausea, sensitive to light, mild confusion, lack of concentration, muscle spasm, neuralgia in left upper and lower extremities, dryness of skin around lips, "peeling/dryness of skin around lips/it appeared patient have eye shadow but peeling was not visible", burning and itch of lip region, post vaccination burning, itching redness to eye lids, and "it appeared patient have eye shadow" was not recovered. Information on the lot/ batch number has been requested.
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| 36 | 2021-01-08 | cold sweat, fever, sweating, headache |
!2 hours after 2nd dose of vaccine experienced sudden onset of Headaches, chills, muscle aches, swea...
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!2 hours after 2nd dose of vaccine experienced sudden onset of Headaches, chills, muscle aches, sweats, diaphoretic / pale clammy skin, fever, and joint pain. all the fore mentioned symptoms were not all at once, every half hour and not all once. some symptoms lingered longer than others.
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| 36 | 2021-01-08 | body temperature increased, chills, headache |
1/7/21 at 0850: received vaccine 1200 - left arm soreness 2200 - headache began 1/8/21 at 0000: seve...
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1/7/21 at 0850: received vaccine 1200 - left arm soreness 2200 - headache began 1/8/21 at 0000: severe chills, worsening headache and neck pain, temperature started to rise, muscle and joint aches began 0500 - chills and aches continued, temperature max of 102.2 0800 - severe muscle aches, fever remained around 102, pulse 130's, SO2 99% 0900-2100 - rested the entire day, unable to move much because my body aches were so severe, when I did get up to go to the bathroom, I could barely walk because my hips and knees hurt so much, headache so severe that I began getting nauseous and dry heaving, I took 650mg acetaminophen and 25mg Benadryl around noon and used ice packs on my neck and the back of my head, ate very little, no appetite, drank water and ginger ale, temperature fluctuated between 101 and 102 all day, came down to 99.6 after acetaminophen, but came right back up to 101 as it wore off 2200 - took 975mg Tylenol and 25mg Benadryl and went to sleep, temperature 100.9 1/9/21 - 0900 - woke up after sleeping all night, temperature 98.2, body aches and headache gone, feel normal
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| 36 | 2021-01-08 | headache |
25 minutes after receiving vaccination ascending numbness of left half of tongue (ipsilateral to loc...
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25 minutes after receiving vaccination ascending numbness of left half of tongue (ipsilateral to location of vaccination site) with associated moderate headache. No tongue swelling or weakness. No breathing difficulty. This was followed by left arm numbness and mild left leg numbness. Left-sided paresthesias /numbness resolved within 3 hours of vaccination. The severity was mild-moderate without there ever being complete loss of sensation. No vision problems or weakness.
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| 36 | 2021-01-08 | shortness of breath |
Developed acute onset eyelid swelling, lip swelling, dyspnea with wheezing and hive like swelling at...
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Developed acute onset eyelid swelling, lip swelling, dyspnea with wheezing and hive like swelling at vaccine site. I self administered 8 puffs of albuterol (my prescription) and took 50 mg of oral Benadryl with improvement in wheezing and swelling at injection site. I continue with some mild unilateral right upper eyelid swelling but much improved.
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| 36 | 2021-01-08 | dizziness | Dizziness Narrative: Dizzy approximately 2-3 minutes after vaccine injection |
| 36 | 2021-01-08 | chills, fever |
Episodic uriticaria started 6 hours after 2nd dose and continue through the 36th hour post vaccinati...
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Episodic uriticaria started 6 hours after 2nd dose and continue through the 36th hour post vaccination. Hives occur with very little palpation of skin. Benadryl has been used for symptomatic relief. Chills, low grade fever, and myalgias occurred at 20 hours post 2nd dose and resolved within 8 hours.
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| 36 | 2021-01-08 | headache, dizziness, fever, chills |
Fever and chills starting 5 hours after dose, joint pain, myalgia, anxiety, palpitations, loss of ap...
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Fever and chills starting 5 hours after dose, joint pain, myalgia, anxiety, palpitations, loss of appetite, fatigue, abdominal pain, dizziness, near syncope, headache, insomnia, arm soreness, tingling and numbness in my face and mouth about 10 hours after dose and lasting about 30 min, taking ibuprofen one tablet q6 hours for fever and pain. 26 hours dose symptoms are improving
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| 36 | 2021-01-08 | headache | Headache & Myalgia Narrative: |
| 36 | 2021-01-08 | fatigue, headache |
Headache, NauseaVomiting nausea, fatigue, brain fog, headache Narrative: Advised symptomatic managem...
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Headache, NauseaVomiting nausea, fatigue, brain fog, headache Narrative: Advised symptomatic management and follow-up with PCP as needed.
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| 36 | 2021-01-08 | fever, fatigue |
Mild fatigue and body aches x 1 day, fever started up to 103 and then full body rash. More severe s...
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Mild fatigue and body aches x 1 day, fever started up to 103 and then full body rash. More severe symptoms started 1/7-1/8, worsened 1/9. Had close contact with two children and husband, but none have any symptoms.
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| 36 | 2021-01-08 | dizziness, malaise, headache |
Probably with in 30 sec of the vaccine being administered I started to not feel well. Felt like it s...
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Probably with in 30 sec of the vaccine being administered I started to not feel well. Felt like it spread through my body, I felt a weird feeling in my chest, throat, my legs felt weak, I was light headed and my heart started to beat hard and fast. It then started to subside over several minutes. The nurse kept me for 30 minutes and then I felt ok to walk out. I had a bit of a headache and didn?t feel right the rest of the night.
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| 36 | 2021-01-09 | headache, fever, fatigue, chills |
Fever of 102 degrees, chills, headache, muscle aches, fatigue, sore arm. Sore arm mild night of inje...
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Fever of 102 degrees, chills, headache, muscle aches, fatigue, sore arm. Sore arm mild night of injection, severe and with back pain upon waking on 1/5. By noon of 1/5, had all symptoms listed above. Continued worsening until I took Motrin 400 mg at 6:00pm. Symptoms improved significantly within 30 minutes, fever resolved. Body aches and sore arm persisted at mild levels for a few days but resolved by 1/8.
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| 36 | 2021-01-09 | fatigue, fever, headache |
Fever, body aches, joint land bone pain, headache. Improved with antipyretics and sleep. This occurr...
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Fever, body aches, joint land bone pain, headache. Improved with antipyretics and sleep. This occurred in the evening, so I?m not sure how long symptoms would have lasted as I went to sleep. I woke up feeling just slight tired and sore.
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| 36 | 2021-01-09 | headache |
Headache, Vertigo, and nausea for one day 7am-3pm, sore arm all day for one day, I used Ibuprofen fo...
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Headache, Vertigo, and nausea for one day 7am-3pm, sore arm all day for one day, I used Ibuprofen for the headache and slept off all the symptoms
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| 36 | 2021-01-09 | malaise, headache, chills | Headache, chills, malaise, nausea, projectile vomiting |
| 36 | 2021-01-09 | lethargy, headache | Lethargy, Headache, Sore arm, Body aches for 36 hours |
| 36 | 2021-01-09 | headache | Pain at site of injection, extreme headache, extreme body pain |
| 36 | 2021-01-09 | throat pain | Sore throat |
| 36 | 2021-01-09 | dizziness |
Syncope at approximately 5:20am this morning. I had been awake and active for about 30 minutes getti...
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Syncope at approximately 5:20am this morning. I had been awake and active for about 30 minutes getting ready for work. As I was walking to my kitchen, I suddenly became very dizzy with blurred vision, tingling hands, nausea, ringing in my ears, and I felt like I was going to lose control of my bowels. I became very weak in the legs and I made it to the couch before I fell. Episode lasted approximately 2 minutes. As I laid down, my symptoms recovered. My husband gave me some juice and toast. After about 20 minutes, I got up and was able to walk without symptoms. I felt perfectly normal prior to this event. Last night, I ate a full dinner and drank about a liter of water. This event did not seem to be precipitated by hypoglycemia or dehydration. For the rest of this day, I have felt normal.
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| 36 | 2021-01-09 | cough | Throat fullness with frequent coughing |
| 36 | 2021-01-09 | dizziness, sweating |
Two minutes after: facial and hand tingling, dizziness. Progressed to intense nausea, diaphoresis, t...
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Two minutes after: facial and hand tingling, dizziness. Progressed to intense nausea, diaphoresis, tachycardia, hypertension.
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| 36 | 2021-01-09 | headache, chills, fatigue, fever | low grade fever, chills, body aches (neck and back), fatigue, headache. |
| 36 | 2021-01-10 | chills, fever |
12 hours after receiving the shot I came down with chills, fever, and body aches. I had three bouts ...
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12 hours after receiving the shot I came down with chills, fever, and body aches. I had three bouts of this over the next 24 hours. The second one had a spike in fever just over 101. I monitored my symptoms closely and used Tylenol as recommended.
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| 36 | 2021-01-10 | headache, fatigue, fever, chills |
Around 1am Saturday morning, I began with a 101.7 fever, muscle aches, joint pain, headache, and chi...
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Around 1am Saturday morning, I began with a 101.7 fever, muscle aches, joint pain, headache, and chills that lasted 36 hours. For the next 12 hours after fever subsided, I was fatigued.
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| 36 | 2021-01-10 | sweating, chills |
Chills and sweats, aches beginning during sleep Nausea and Vomiting and diarrhea persisted until abo...
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Chills and sweats, aches beginning during sleep Nausea and Vomiting and diarrhea persisted until about 8am next day Next day fatigue and lack of appetite, resolved within 24 hours with slight residual Epigastric pain
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| 36 | 2021-01-10 | chills, fatigue |
Chills, body aches, fatigue, lower back pain, and eye pain. No treatment. minor improvement will c...
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Chills, body aches, fatigue, lower back pain, and eye pain. No treatment. minor improvement will continue to monitor
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| 36 | 2021-01-10 | chills | Chills, body aches, fatigue, lower back pain, eye pain. No treatment with minor improvement |
| 36 | 2021-01-10 | dizziness | DIZZY LIGHTHEADED , FEELING LIKE PASSING OUT, HEART RACING. |
| 36 | 2021-01-10 | dizziness |
Had palpitations while I was sleeping that woke me up. Had numbness to right and left arms. Later th...
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Had palpitations while I was sleeping that woke me up. Had numbness to right and left arms. Later that morning around 1130 had palpitations, dizziness, lightheaded ness that would not go away even when sitting down. I felt numbness around my mouth took blood pressure and it was elevated 200 systolic and 100 systolic called EMS they assessed my blood pressure but it was normal systolic 130?s which is hi for me Norma blood pressure for me 90-100 systolic
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| 36 | 2021-01-10 | dizziness, chills, headache, fatigue |
Headache, body aches, chills, fatigue, dizziness, confusion, extremity tingling in first 24 hours. A...
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Headache, body aches, chills, fatigue, dizziness, confusion, extremity tingling in first 24 hours. At 26 hours post injection, severe left axillary lymphadenopathy noted with axillary pain.
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| 36 | 2021-01-10 | fatigue, migraine |
I would say the day after mild injection site pain, then at 10 days after mild fatigue and at 14 day...
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I would say the day after mild injection site pain, then at 10 days after mild fatigue and at 14 days after a migraine.
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| 36 | 2021-01-10 | fever, headache | Patient began to experience neck pain, myalgias, headache on 12/30. Fever on 1/1. |
| 36 | 2021-01-10 | dizziness |
Patient reported prior to vaccination hx of anaphylaxis to shellfish and macrobid. She was a 30 min...
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Patient reported prior to vaccination hx of anaphylaxis to shellfish and macrobid. She was a 30 minute post-vaccine nurse monitoring. ~15 minutes after receiving vaccination, patient reported to the nurse dizziness, nausea. Nurse placed patient on stretching and called for provider assistance. SBP in 160s, DBP >100, HR 130s or higher, oxygen saturation on room air ~98%. Epinephrine 0.3mg IM administered. Nurse placed Nasal cannula oxygen with oxygen saturation 100%. Patient BP improved, HR improved to low 100s occasionally in 110s if patient talking to someone new such as Fire response. Patient reported continued dizziness. BP prior to EMS arrival 146/91 left arm automatic cuff, Temp 98.3F, P 106, oxygen on nasal cannula 100%. Upon EMS arrival, patient transferred to ER.
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| 36 | 2021-01-10 | dizziness, headache |
Patient reported, "I received my Covid 19 vaccination on Monday evening. I experienced a reaction im...
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Patient reported, "I received my Covid 19 vaccination on Monday evening. I experienced a reaction immediately following. Within 10 minutes I had tachycardia (130s), high BP (160s), lightheadedness, nausea, headache, and feeling like I was going to faint. I was attended to by Ambulance paramedics. At the time of her report to her primary care provider on 1/7/2021, she was still having pretty significant side effects (headache, dizziness, and light sensitivity), enough so that I was staying home from work. These symptoms have now resolved.
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| 36 | 2021-01-10 | body temperature increased | Post vaccine Day 5 post temp at 101.5 and Day 6 T 100 |
| 36 | 2021-01-10 | cough, fatigue, headache |
Starting 3 days after the vaccine (1/3/21) she had a severe headache. The next day she also had naus...
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Starting 3 days after the vaccine (1/3/21) she had a severe headache. The next day she also had nausea and a mild cough. She was tested for COVID which was negative. She felt better by 1/5/21, but had muscle aches and fatigue on 1/7/21 and 1/9/21.
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| 36 | 2021-01-10 | body temperature increased, sweating, headache, chills |
Starting Thursday late afternoon I had a severe headache, temperature 100.7, chills, sweats, nausea,...
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Starting Thursday late afternoon I had a severe headache, temperature 100.7, chills, sweats, nausea, but then Friday early morning my blood sugar was super high 400?s and then Saturday dropped super low 30?s, Sunday super low and Monday super low also.
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| 36 | 2021-01-10 | weakness |
eventually inability to move arm; pain; joint pain; tenderness at injection site; loss of strength; ...
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eventually inability to move arm; pain; joint pain; tenderness at injection site; loss of strength; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EJ1685) intramuscular at arm left, on 19Dec2020 06:45 at single dose for covid-19 immunisation. Medical history included ongoing acne. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included isotretinoin (ACCUTANE). On 19Dec2020 11:30, approximate 5 hours after vaccine, the patient experienced pain, joint pain and tenderness at injection site, progressively loss of strength and eventually inability to move arm. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was recovered.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 36 | 2021-01-10 | malaise, fatigue, headache | headache, nausea, acid reflux, joint and muscle aches, nausea, malaise, fatigue, restlessness |
| 36 | 2021-01-10 | headache, chills, fever |
nausea and vomiting for 1 hour, approx. 15 hours after vaccine receipt. Accompanied by low grade fev...
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nausea and vomiting for 1 hour, approx. 15 hours after vaccine receipt. Accompanied by low grade fever (99.3F), chills, rigors, headache
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| 36 | 2021-01-10 | fatigue, fever |
started with soreness to the right armpit after few hours. had some fever that night. woke up feelin...
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started with soreness to the right armpit after few hours. had some fever that night. woke up feeling very tired and rested most morning. pain had moved to right upper chest that morning and then to the right neck. she also felt a tender lymph node in the right supraclavicular area. took tylenol to help on saturday. symptoms are getting better now
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| 36 | 2021-01-10 | somnolence |
tongue not swollen but felt sluggish/tongue felt strange, it was sluggish to swallow; tongue felt st...
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tongue not swollen but felt sluggish/tongue felt strange, it was sluggish to swallow; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/Her tongue felt strange; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/felt hard to swallow; hot flash; flush feeling all over her face/flush all over her face/she felt flush; arm was sore; arm was sore and heavy; drowsiness; pain and redness at injection site; pain and redness at injection site; This is a spontaneous report from a contactable nurse reporting for herself. A 36-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiry date not provided) on 23Dec2020 09:15 intramuscularly in the left arm for COVID-19 immunisation (reported as preventive). There was no relevant medical history and no concomitant medications. The nurse (patient) received her first dose of the vaccine on 23Dec2020 at the hospital that she worked at. She was kept there for 15 min for monitoring and she felt fine. About 30 minutes post vaccination she got a hot flash, a flush over her face, she does not know if she was red but she felt flush. Her tongue felt strange, nothing swelled that she could tell, it felt hard to swallow, to make the motion to swallow it felt kind of sluggish. She felt weird swallowing which lasted for only a few minutes. She never struggled to breathe. She went back to park in the hospital parking lot since she was not sure if she was experiencing a anaphylactic reaction and then after a few minutes it went away. Her arm was sore and heavy feeling for that day. She had drowsiness for a couple of hours and pain and redness at the injection site for a couple of days that was not bothersome, it was mild. No relevant test. She wanted to know if she should get the second dose of the vaccine due to the symptoms she had after the first dose. The pain and redness at injection site was resolved on an unspecified date in Dec2020, while the other events were resolved on 23Dec2020. The reporting nurse considered the events hot flash, flush all over her face, arm was sore and heavy, drowsiness, pain and redness at injection site were non-serious, while the events "tongue felt strange, it was sluggish to swallow" were serious that she drove back to the hospital (no emergency room/phycian office visit). She considered the events were related to the vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162Bw on the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 36 | 2021-01-11 | body temperature increased |
A COUPLE OF HOURS AFTER VACCINE, PALPITATIONS AND TACHYCARDIA. THIS LASTED FOR 5 DAYS, SO SHE WENT T...
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A COUPLE OF HOURS AFTER VACCINE, PALPITATIONS AND TACHYCARDIA. THIS LASTED FOR 5 DAYS, SO SHE WENT TO SEE A HEART DR. LATER THAT EVENING, TEMP OF 101.
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| 36 | 2021-01-11 | dizziness |
Began having numbess to face, tingling to hands and legs and dizziness that started roughly 6 hours...
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Began having numbess to face, tingling to hands and legs and dizziness that started roughly 6 hours after injection; felt dizzy with movement and that her legs were going to give out.
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| 36 | 2021-01-11 | fatigue, weakness |
Day 0: Patient developed fatigue, headache, weakness, muscle aches. Describes muscle weakness as m...
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Day 0: Patient developed fatigue, headache, weakness, muscle aches. Describes muscle weakness as mostly in her legs, feeling like they are going to give out. Grip strength normal. No difficulty breathing. Pain in neck and back similar to pain she experiences with ankylosing spondalitis. No numbness or tingling in hands and feet. Day 8: COVID test done - negative. No other tests run. Day 10: COVID PCR test done - also negative. No other tests run. Spoke with rheumatologist who believes it could be related to AS. Day 15: Still experiencing side effects - very fatigued. This is the first day she has been out of bed for more than a few hours at a time. Planned visit with PCP tomorrow.
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| 36 | 2021-01-11 | fever, fatigue |
Day of shot: she reported "tingling fingers" and "mild fogginess - like I took Benadryl" - declined ...
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Day of shot: she reported "tingling fingers" and "mild fogginess - like I took Benadryl" - declined MD assessment (and states this resolved within hours. Day after shot (1/9), she states she noted redness/tenderness at site, fatigue, body aches, fever to 103 (responsive to tylenol; reduced to 99.4 after 8hrs). She presents to AOH 01/12/21 for assessment of L deltoid: 8x8.5cm injection site erythema/tenderness/very mild induration. States fever has resolved; neck/back aches continue; tenderness at site continues. Possible cellulitis? Advised to seek PCP counsel as soon as possible.
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| 36 | 2021-01-11 | dizziness, headache | Dizziness, vomiting, headache, and nausea |
| 36 | 2021-01-11 | fatigue, chills | Fatigue, chills, nausea, diarrhea, muscle and joint pain |
| 36 | 2021-01-11 | fatigue, fever | Fever (101), intense body aches, fatigue, joint pain |
| 36 | 2021-01-11 | headache |
Headache, strong arm pain and redness at injection site, apart from these usual side-effects of the ...
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Headache, strong arm pain and redness at injection site, apart from these usual side-effects of the vaccine, she sees gray cloud-like vision, intermittently, usually gets worse during the afternoon.
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| 36 | 2021-01-11 | malaise, fatigue, weakness |
Inital onset of arm tenderness then heaviness in left arm. This was followed by increased weakness a...
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Inital onset of arm tenderness then heaviness in left arm. This was followed by increased weakness and tingling in entire left side. I found it difficult to ambulate and lift my arm at all. This was followed by malaise, weakness, and fatigue. The decreased strength and sensation on the left side of my body lasted for several hours, gradually fading around 4am. The weakness of the left side of the body improved over time and I was just left with fatigue and malaise.
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| 36 | 2021-01-11 | fatigue, fever, headache, chills |
Injection site soreness, axillary lymphadenopathy proximal to injection site, fever (max 102 - tympa...
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Injection site soreness, axillary lymphadenopathy proximal to injection site, fever (max 102 - tympanic) lasting for > 4 days poorly responsive to antipyretics, headache, arthralgias, myalgias, neck stiffness/pain, hip pain, low back pain, nausea, anorexia, extreme fatigue, severe chills.
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| 36 | 2021-01-11 | chills, sweating, fever |
Low grade fever, body aches, chills, nausea/motion sickness on Saturday. Sunday to Tuesday: nausea a...
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Low grade fever, body aches, chills, nausea/motion sickness on Saturday. Sunday to Tuesday: nausea and difficulty cooling down/sweating present
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| 36 | 2021-01-11 | malaise, fatigue, headache | Malaise, aches, headache, nausea, fatigue |
| 36 | 2021-01-11 | throat irritation |
Patient endorsed an 'odd' and 'scratchy-like' feeling in her throat @ 1520. Famotodine 40mg , Diphe...
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Patient endorsed an 'odd' and 'scratchy-like' feeling in her throat @ 1520. Famotodine 40mg , Diphenhydramine HCl 50mg, and Cetirizine HCl 10mg given PO after No contraindications determined @ 1530. VSS : SpO2 99-100% on RA, HR 64, NIBP 90s/50s (62-67) - 'baseline' per Patient w no c/o orthostasis. Feeling better by 1550. Was released to home w f/u phone call @ 1726 to find her at home and feeling 'much better'. She will report this to her PCP.
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| 36 | 2021-01-11 | dizziness |
Patient received vaccine at 606 pm, began having reaction symptoms at 612 pm, reports symptoms as fe...
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Patient received vaccine at 606 pm, began having reaction symptoms at 612 pm, reports symptoms as feeling dizzy/lightheaded, also reports tingly lips. Patient stayed for observation for 30 minutes, once complete, reported still feeling slightly dizzy/lightheaded, but this is a normal reaction for her to vaccines per patient. Offered patient juice, and patient felt OK to leave, no medications given.
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| 36 | 2021-01-11 | influenza like illness |
Patient states that she received her second vaccination and in the hours after she had flu-like symp...
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Patient states that she received her second vaccination and in the hours after she had flu-like symptoms. Then over the next few days, she started to notice tingling and a "prickly" sensation in various areas. This progressed to symmetric BLE weakness which started in her feet and had reached to just above her knees bilaterally time and she arrived. The weakness had progressed to her hips. She also noticed weakness in her arms and they are easily fatigued. She is able to walk but it takes much effort.
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| 36 | 2021-01-11 | chills, sweating, fatigue |
Pfizer-biotentech covid 19 vaccine EUA Body aches fatigued started at 3pm1/11. By 12am 1/12 unable ...
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Pfizer-biotentech covid 19 vaccine EUA Body aches fatigued started at 3pm1/11. By 12am 1/12 unable to sleep due to Such severe pain all over head to toe, chills/shaking , vomiting and sweats. As of now today 1/12 1pm still very achey and fatigued with waves of nausea.
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| 36 | 2021-01-11 | chills, migraine, throat irritation, headache, fatigue |
Received the second dose on 1/8- Felt tired with muscle aches and minor headache. Felt pain and sore...
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Received the second dose on 1/8- Felt tired with muscle aches and minor headache. Felt pain and soreness around injection site. On 1/9- had a severe migraine was unable to get out of bed due to migraine and extreme light sensitivity. Experienced severe muscle aches and chills. 1/10- started experiencing facial swelling especially of the left side. Extreme left eye swelling. With headache. Went to ER. Was given Benadryl to reduce swelling fluids and Prilosec for throat irritation. 1/11-started experiencing left arm numbness and tingling radiating down to fingertips. Experience left side facial numbness and tingling. 1/12- symptoms have begun to improve.
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| 36 | 2021-01-11 | chills | Right arm pain (injection site), nausea, chills |
| 36 | 2021-01-11 | weakness, dizziness, headache, throat pain, fatigue, chills, malaise |
Sore throat; Headache; Felt out of sorts/ feeling unwell; Bizarre feeling/felt really bad; wondering...
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Sore throat; Headache; Felt out of sorts/ feeling unwell; Bizarre feeling/felt really bad; wondering if being on Stelera made the symptoms from the COVID Vaccine worse; extreme/ severe fatigue; lightheaded; soreness around injection/Sore arm; felt run down; chills; This is a spontaneous report from a contactable nurse (patient). This 36-years-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, Expiry Date: 31Mar2021), via unspecified route at left arm on 21Dec2020 14:00 at single dose for COVID-19 immunization; she also started to receive ustekinumab (STELERA injection), via subcutaneous from 2017 (last injection on 04Nov2020) at unspecified dose every 12 weeks for psoriasis. Medical history was none. Concomitant medications were not reported. No additional vaccines administered on same date of Pfizer vaccine. Historical vaccine included influenza vaccine on Nov2020 for immunization, which was 5 weeks prior to COVID vaccine. Vaccination facility type was hospital. At night of vaccination on 21Dec2020, patient felt run down, thought she had chills. She did not have fever. She woke up next day 22Dec2020 with sore arm/ soreness around injection, was otherwise fine. Day 2, 3, and 4 post vaccine was sick (23Dec2020). She had a sore throat, headache, and extreme/ severe fatigue on 23Dec2020. She was not feeling well/ felt out of sorts on 23Dec2020. She expected to wake up feeling unwell. On 23Dec2020 and 24Dec2020 she felt really bad. Could have been in bed all day. She still did not have fever. She was lightheaded and had a bizarre feeling on 23Dec2020. She woke up 26Dec2020 and felt completely fine. Patient was wondering if being on ustekinumab made the symptoms from the COVID Vaccine worse. Action taken for ustekinumab was unknown. Outcome of events was recovered on 26Dec2020.
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| 36 | 2021-01-11 | headache, fever |
Soreness at injection site started at 1600 Body aches, headache, and low grade fever woke me up arou...
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Soreness at injection site started at 1600 Body aches, headache, and low grade fever woke me up around 0100
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| 36 | 2021-01-11 | fatigue, shortness of breath, dizziness |
Vaccine administered at approx. 9 am. At 1000am , began feeling very tired, dizzy. S/sx increased ov...
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Vaccine administered at approx. 9 am. At 1000am , began feeling very tired, dizzy. S/sx increased over the next 2 hours. - began vomiting, felt very "slow motion". At approx. 1 pm, went back to vaccine area; felt like there was more effort to breath (heaviness); given epi-pen in ED, S/sx improved, Hydration started.
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| 36 | 2021-01-11 | weakness, fever, nasopharyngitis, headache, fatigue, chills |
around 14 hours past vaccine woke up with chills, low grade fever (100.8), severe calf pain and body...
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around 14 hours past vaccine woke up with chills, low grade fever (100.8), severe calf pain and body aches all over, and severe headache, around 3am had nausea to the point of needing zofran, chills continued until around 5am, body aches continued and was yelling, crying and tossing and turning, woke up at around 8am with 9/10 headache, light and sound sensitivity, alleviated some with coffee, extremely fatigued and weak (had trouble walking half a block), headache mostly gone by. 10am, fatigue continued throughout the day, NO appetite, intermittent chills. At bedtime ~9pm day 2 temperature 99.8. Slept through night. Sunday fatigue and excercise intolerance (typically exercise daily and am in good physical shape), had to sit down during walks with dog, Monday fatigue continued as did difficulty exercising long periods of time until afternoon, continued difficulty monitoring body temperature, getting cold really easily. Tuesday (today) continued weakness and exhausted but can't nap, no appetite. Never took anything except zofran 2x for nausea
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| 36 | 2021-01-11 | dizziness |
began having numbness to face, tingling to hands and legs and dizziness with movement and that her l...
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began having numbness to face, tingling to hands and legs and dizziness with movement and that her legs were going to give out
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| 36 | 2021-01-11 | chills, fever |
had vaccine on Saturday12/19/20, felt ok and then Sunday night / Monday am she developed a fever and...
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had vaccine on Saturday12/19/20, felt ok and then Sunday night / Monday am she developed a fever and chills. Associate called manager, manager advised associate to call Occ Health. Occ Health sent associate for COVID testing. Associate is home resting.
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| 36 | 2021-01-11 | headache |
is pregnant: yes; Extremely sore arm; body aches; headache; This is a spontaneous report from a cont...
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is pregnant: yes; Extremely sore arm; body aches; headache; This is a spontaneous report from a contactable other health professional (patient). This reporter reported information for both mother and fetus/baby. This is a maternal report. A 36-year-old female patient (pregnant) receive first dose of BNT162B2, via an unspecified route of administration on 04Jan2021 16:45 in right arm at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient experienced extremely sore arm, body aches, headache on 04Jan2021. The adverse event was not resulted in emergency room visit and physician office visit. The events were reported as non-serious. No treatment received for the adverse event. The mother reported she became pregnant while taking bnt162b2. Last menstrual date was 12Jun2020. The mother was 29 weeks pregnant at the onset of the event. The mother was due to deliver on 19Mar2021. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient wasn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks: Prenatal vitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Allergies to medications, food, or other products was no. The outcome of events was resolving. Information on the Lot/batch number has been requested.
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| 36 | 2021-01-11 | body temperature increased, head discomfort, weakness |
it was like having Covid again; it was like having Covid again; body aches; dry mouth; generalized w...
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it was like having Covid again; it was like having Covid again; body aches; dry mouth; generalized weakness; temp was 38.1 Celsius; head feels weird; can't sleep; decreased appetite; pain at the injection site; This is a spontaneous report from a contactable Nurse (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19 from Mar2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced body aches, dry mouth, can't sleep, generalized weakness, decreased appetite, and pain at the injection site, temp was 38.1 Celsius, head feels weird in Jan2021. The patient got her first dose and was looking online to see the symptoms. She said that she saw that during the trials, people were experiencing the symptoms she was experiencing after the second dose and she was concerned. She said that she wanted to make sure her symptoms are ok and to make sure that the symptoms are not just caused from the booster, but also from the first dose. The caller said that her mom told her that someone died from the Pfizer vaccine. No further details provided. The patient was having body aches, could not sleep, her mouth is really dry, her temp was 38.1 Celsius, her head feels weird, she has generalized weakness, pain at the injection site, and decreased appetite. She said that it was like having Covid again. She said that she had Covid back in Mar2020. The patient underwent lab tests and procedures which included body temperature: 38.1 centigrade. The outcome of all the events was unknown. The events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the suspected COVID likely represents a pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 Nucleic acid/ PCR test is needed for full medical assessment.
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| 36 | 2021-01-12 | chills, fever, fatigue | Body aches, chills, fever, fatigue. Treatment include Tylenol and Motrin. Fever resolved |
| 36 | 2021-01-12 | shortness of breath, dizziness, migraine |
Had Vaccine on 12/24. Since then she has had daily episodic full-body itchiness and rash or redness...
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Had Vaccine on 12/24. Since then she has had daily episodic full-body itchiness and rash or redness; light-headedness, migraines, irregular heartbeat. She has also noted episodic throat tightness and SOB in the 10 days since the vaccine. She has a history of anaphylaxis w/ morphine. She has an autoimmune condition currently being evaluated by rheumatology. Has Von Willibrands and Hx stroke due to BCP. Will need Allergy Consultation with MD prior to 2nd dose.
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| 36 | 2021-01-12 | chills, fever |
I have had a sore arm; I also have been having a low-grade fever the highest it has been 99.5; Body ...
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I have had a sore arm; I also have been having a low-grade fever the highest it has been 99.5; Body aches; Chills; This is a spontaneous report from a contactable nurse reporting for self. A 36-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EK923, via an unspecified route of administration on 05Jan2021 08:45 as a single dose (dose 1), left arm (age at vaccination: 36 years old), for COVID-19 immunization. The patient was not pregnant at the time of vaccination. There was no other vaccine administered in the 4 weeks prior to the COVID vaccine. Medical history included multiple sclerosis and hypothyroidism . The patient was receiving unspecified concomitant medications ("10 meds").The patient previously took copaxone and experienced drug allergy. The patient reported having a sore arm, but also had been having a low-grade fever. The highest it had been was 99.5. The patient also had body aches and chills. These symptoms started couple hours after the injection (on 05Jan2021) and have been with the patient since then. The events were reported as non-serious. There was no hospitalization or treatment received for the events. The outcome of the events sore arm, low grade fever, body aches, and chills was not recovered. The patient had not been COVID-19 tested post vaccination.
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| 36 | 2021-01-12 | shortness of breath, chills, cough, headache, fever |
Note: I am currently breastfeeding. Had body aches; chills; fever of 102.6; headache; nausea; cough;...
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Note: I am currently breastfeeding. Had body aches; chills; fever of 102.6; headache; nausea; cough; shortness of breath - I went to ER and that is where I received COVID positive test and positive tests for COVID Pneumonia and Microplasm Pneumonia as well. Stayed overnight in ER observation - 2 am to 8 am . Went home next morning and was quarantined approximately 8 days. Body aches and a cough had started two days prior to injection. IV antibiotics at the hospital and oral antibiotics at home. Received nebulizer breathing treatments. Pain meds and anti-inflammatory medication.
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| 36 | 2021-01-12 | discomfort |
Numbness,tingling in both upper and lower extremity, especially left foot and hand which began sever...
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Numbness,tingling in both upper and lower extremity, especially left foot and hand which began several hours after vaccination. Day 6 post vaccine, numbness and tingling began in right hand. Associated symptoms include heaviness, mild weakness of extremities described above.
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| 36 | 2021-01-12 | headache |
Patient reports severe headache, vomiting and eye sensitivity to light and eye pain that lasted app...
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Patient reports severe headache, vomiting and eye sensitivity to light and eye pain that lasted approx 24 hours. 48 hours post injection Patient is complaining of significant muscle pain around her neck area.
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| 36 | 2021-01-12 | lethargy |
Received the 2nd Covid-19 vaccine approx 10am, approx 7 hours later she became red, lethargic, felt ...
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Received the 2nd Covid-19 vaccine approx 10am, approx 7 hours later she became red, lethargic, felt like she had resistance against her movements, and was "going through jello". She went home, took Benadryl 25 mg, now with rash/hives along various areas, behind her ears. Has an epipen at home but has never had to use. Denies any throat swelling or scratching, no shortness of breath.
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| 36 | 2021-01-12 | fatigue |
SOB: 25 min post injection, lasted 1 min then resolved. Nausea 1 hr post dose, intermittent, sever ...
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SOB: 25 min post injection, lasted 1 min then resolved. Nausea 1 hr post dose, intermittent, sever x12 hours, then intermittent and mild x1 additional day. Fatigue & pain at injection site.
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| 36 | 2021-01-12 | shortness of breath, fatigue |
SOB: ~25 min post injection, lasted ~1 min then resolved. Nausea 1 hour post dose, intermittent, sev...
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SOB: ~25 min post injection, lasted ~1 min then resolved. Nausea 1 hour post dose, intermittent, sever x12 hours, then intermittent and mild x1 additional day. Fatigue & pain at injection site
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| 36 | 2021-01-12 | headache, chills, chills, headache |
Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Headache-Mild, Systemic: Eleva...
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Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Headache-Mild, Systemic: Elevated blood pressure. Rose to 140/110. No history of HTN. Returned to patient's normal blood pressure measure of 130/90 30-45 minutes after receiving the vaccine.
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| 36 | 2021-01-12 | lethargy, headache |
Swollen lymph nodes at various times over 2 weeks. Consistent, intermittent headaches. Lethargy.; Co...
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Swollen lymph nodes at various times over 2 weeks. Consistent, intermittent headaches. Lethargy.; Consistent, intermittent headaches; Swollen lymph nodes at various times over 2 weeks. Consistent, intermittent headaches. Lethargy.; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 Lot number=EL1284, via an unspecified route of administration on 22Dec2020 11:15 at single dose in the left arm for COVID-19 immunization. Medical history included Allergies to Penicillin. Concomitant medication included melatonin, diphenhydramine hydrochloride (BENADRYL) and celecoxib (CELEXA). On 21Dec2020 19:00 (pending clarification), the patient experienced swollen lymph nodes at various times over 2 weeks, consistent, intermittent headaches and lethargy. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 04Jan2021. The outcome of the events was unknown.
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| 36 | 2021-01-12 | cold sweat, weakness, dizziness |
Within minutes of receiving the vaccine, started c/c dizziness, tingling all over, feeling "splotchy...
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Within minutes of receiving the vaccine, started c/c dizziness, tingling all over, feeling "splotchy", weakness, seeing stars. Appeared pale and clammy. Eased to floor to lie flat. B/P=92/62. B?P after 5 min of being supine 102/64. Able to sit up after 10 minutes. Continued to rest for 30 minutes with slow consistent improvement in weakness and dizziness. Left clinic within one hour with improvement.
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| 36 | 2021-01-12 | fatigue, shortness of breath |
broke out into hives in my face and neck; short of breath; Exhaustion; This is a spontaneous report ...
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broke out into hives in my face and neck; short of breath; Exhaustion; This is a spontaneous report from a contactable Other Health Professional (patient). A 36-year-old female patient received first dose of BNT162B2 (Pfizer BioNTech COVID-19 EUA30, lot# EL1284), via an unspecified route of administration in left arm on 28Dec2020 08:45 at single dose for covid-19 immunization. Medical history included Allergies: Penicillin, Bactrim (sulfamethoxazole, trimethoprim), tomatoes. The patient's concomitant medications were not reported. After 25 minutes of getting the first dose of the vaccine, the patient broke out into hives in face and neck. Hives continued for days. By day 3, the patient was checked into the hospital for short of breath, hives and exhaustion. A week after dose 1, the patient still had hives and slight shortness of breath. Pregnant at the time of vaccination: No. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. AE treatment: COVID test and steroids. If COVID prior vaccination: No. If COVID tested post vaccination: Yes. Covid test post vaccination: Nasal Swab on 01Jan2021, Negative result. Facility where the most recent COVID-19 vaccine was administered: Hospital. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: NO. The outcome of all the events was not recovered. Serious: no. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: no. Seriousness criteria-Caused/prolonged hospitalization: no. Seriousness criteria-Disabling/Incapacitating: no. Seriousness criteria-Congenital anomaly/birth defect: no.
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| 36 | 2021-01-12 | fever | fever. called in sick to work. |
| 36 | 2021-01-12 | chills, headache |
hearing loss; ringing and pulsating in her ears; Chills; Headache; This is a spontaneous report from...
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hearing loss; ringing and pulsating in her ears; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration in in the left arm on 04Jan2021 at single dose for covid-19 immunization. Medical history included ongoing acid reflux. The patient had no concomitant medications. The patient previous received the flu shot. The patient experienced hearing loss, ringing and pulsating in her ears on 05Jan2021, headache on 04Jan2021, chills on 05Jan2021. Treatment was none. She had the vaccine on Monday at work and some of the symptoms that she has had have not resolved. She was having ringing in her ears and hearing loss. Went to see them and had her ears looked at. Everything was normal. Got the vaccine on 04Jan2021. Ringing in ears and hearing loss: Had been very consistent with no improvement. If anything, it had worsened. She was going to re-contact her doctor. She was also going to ask, should she go on Prednisone or something. She was worried she was going to lose her hearing. Her doctor said that a hearing test may need to be done. History: Takes one medication that she has been taking for years. She has never had an adverse event to any vaccine before. She got the flu shot every year. She was expecting the chills and headache, but they resolved fast. The next vaccine was 25Jan2021, the patient was asked whether she should get the second dose. The outcome of events for hearing loss, ringing and pulsating in her ears was not resolved, for headache and chills was resolved on 06Jan2021.
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| 36 | 2021-01-12 | fever, fatigue, throat pain, chills, headache |
light sensitivity; joint pain in my fingers while typing/worsening joint; muscle soreness in my uppe...
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light sensitivity; joint pain in my fingers while typing/worsening joint; muscle soreness in my upper back/worsening muscle pain everywhere; a headache; a slightly sore throat/worsening sore throat; a fever; chills; nausea; severe fatigue; tingling; numbness in all extremities at random locations; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), intramuscularly on 05Jan2021 at 18:30 on Left arm at single dose for COVID-19 immunization in hospital. None other vaccine received on same date. The patient medical history included Hypothyroid Generally healthy; Hx of depression and ADHD (Attention deficit hyperactivity disorder); and prior to vaccination, patient was diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE); ibuprofen; cetirizine hydrochloride (ZYRTEC). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly on 15Dec2020 at 18:30 on Left arm at single dose for COVID-19 immunization; and had known allergies with Sulfa and ciprofloxacin hydrochloride monohydrate (CIPRO) drugs, tramadol and oxycodone hydrochloride;oxycodone terephthalate;paracetamol (PERCOCET). The patient experienced on 06Jan2021 at approximately 9am hour, she noticed joint pain in her fingers while typing, muscle soreness in her upper back, a headache, and a slightly sore throat. It quickly went down hill with a fever, chills, worsening joint and muscle pain everywhere, nausea, severe fatigue, worsening sore throat, tingling and numbness in all extremities at random locations. Then at 3pm, about 21 hours since vaccination-fever had broken once but returned quickly, and severe headache with light sensitivity. The joint pain and numbness had faded but she was left with severe muscle soreness, like she was in a car accident. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the event. The outcome of the event Muscle soreness was not recovered, outcome of the other events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
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| 36 | 2021-01-13 | chills, fatigue, headache, fever, shortness of breath, dizziness |
After first vaccine i experienced fatigue, body aches, headache and nausea for 2 days and injection ...
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After first vaccine i experienced fatigue, body aches, headache and nausea for 2 days and injection site pain for two weeks. After second Vaccine given at 9:55am. tingling of feet for about 20 mins, 30 mins after the vaccine. Two hours later fatigue, body aches, headache and nausea began. At 0030 1/12/2021 I woke up with severe chills and left chest pain, temp was 101.6 and heart rate was 160. I began to see black and chest pain was severe feeling like i was having a heart atack and was going to pass out so i called 911. I then began to get short of breath and got numbess on my legs, left arm and left side of neck. Chest pressure/pain radiated to left arm and neck. I was taken by the ambulance to hospital. Arrived around 0130. My heart rate sustained at 140s in the ER so I was admitted at 0530 am. My D Dimer was a bit elevated as well as my lactic so I was given a bolus of fluids plus maintenance. I had a CXR done, CTA chest(negative for PE), UA, Labs, entire cardiac workup including an ECHO during my admission. I also began to have loose stools and wrist joint pain. MY heart rate sustained at 125-147 for about 30 hours. Fevers on and off. After everthing was negative we determined this was secondary to the covid 19 vaccine. I was discharged 1/13/2021 at around 1:30 pm. My heart rate is still not at baseline which is 87-90. I'm 100-130 and still get very fatigued with a simple slow walking. Still having tachycardia, fevers, body aches, joint wrist pain, chest discomfort and headaches. My potassium was 3.0 at discharge so will be needing labs in a week. Also bruised a little different than I usually do with lab draws so keeping an eye on them and will be checking my platelets again in a week. Ive been taking tylenol for my fever and pain and ativan for any anxiety when my heart rate goes up. (treatment during hospital stay was normal saline bolus, nomal saline maintenance fluids at 150 cc/hr, tylenol, ativan, ice packs, rest)
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| 36 | 2021-01-13 | malaise |
Approximately 12 hours after receiving the booster dose, she awoke feeling extremely ill and nauseou...
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Approximately 12 hours after receiving the booster dose, she awoke feeling extremely ill and nauseous, roused me to say so, and then immediately became unresponsive and pulseless. She was admitted to hospital for cardiac work up, and all diagnostic tests have found her heart to be normal in structure and function. Cardiology believes she experienced a vasovagal syncope with asystole. She remains hospitalized at this time for initiation of sotalol therapy; she was diagnosed with frequent PVCs approximately 1 year ago.
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| 36 | 2021-01-13 | malaise |
Body aches, joint pain, malaise, viral rash extending from trunk up my neck and into my scalp, start...
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Body aches, joint pain, malaise, viral rash extending from trunk up my neck and into my scalp, started the night of the vaccine and continuing today, two days post.
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| 36 | 2021-01-13 | dizziness |
Employee had same reaction as Dose # 1 despite pre-medicating with Benadryl and having a consult wit...
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Employee had same reaction as Dose # 1 despite pre-medicating with Benadryl and having a consult with an Allergist. Dizziness, Lightheaded, Tongue and Facial Tingling
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| 36 | 2021-01-13 | shortness of breath, cough |
Employee received vaccine. Within minutes she had red blotches and a rash on neck and down trunk are...
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Employee received vaccine. Within minutes she had red blotches and a rash on neck and down trunk area and coughing/shortness of breath. Employee was administered liquid benedryl for the minor allergic reaction.
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| 36 | 2021-01-13 | headache, fatigue | Fatigue, GI upset, and Headache for 3-4 days post second vaccine |
| 36 | 2021-01-13 | headache, fever | Fever of 104.2 off and on, muscle aches, nausea, headache |
| 36 | 2021-01-13 | chills, body temperature increased, fatigue |
First 24-48 hours: Riggers, 102 temp, myalgias, fatigue, tachycardia 2-4 days: Diarrhea, low grade t...
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First 24-48 hours: Riggers, 102 temp, myalgias, fatigue, tachycardia 2-4 days: Diarrhea, low grade temps, myalgias, fatigue and tachycardia Day 6: new onset of hives all over body, in addition to fatigue and diarrhea
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| 36 | 2021-01-13 | fever, headache | Headache, arm pain, fever |
| 36 | 2021-01-13 | dizziness, fever, headache, shortness of breath | Headache,dizziness, sob, chest pain, nausea, vomiting, fever, muscle and joint pain. |
| 36 | 2021-01-13 | headache, fatigue |
Headache; body aches; didn't feel good; joint pain and muscle aches and fatigue; Lasted about 24 hou...
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Headache; body aches; didn't feel good; joint pain and muscle aches and fatigue; Lasted about 24 hours exactly. Then felt fine after that. Pregnant: June 21, 2021; noneventful
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| 36 | 2021-01-13 | fever, headache |
In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever...
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In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; This is a spontaneous report from a contactable other HCP (patient). A 36-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231), intramuscularly on 06Jan2021 14:45 at single dose in Left arm for COVID-19 immunisation. No Pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Irritable bowel syndrome. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included fluticasone propionate, ethinylestradiol, norethisterone (WERA). The patient experienced In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4 on 07Jan202105:30 AM. No treatment received for the adverse events. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome was unknown.
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| 36 | 2021-01-13 | dizziness |
Itchy on her right arm and upper right torso area; Dizzy and lightheaded; This is a spontaneous repo...
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Itchy on her right arm and upper right torso area; Dizzy and lightheaded; This is a spontaneous report from a contactable nurse (patient). A 36-year-old-female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO140), via an unspecified route of administration in right arm, on 06Jan2021 at 08:30, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to gluten and penicillin (PCN). There were no concomitant medications. The patient previously took cefaclor (CECLOR) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in the patient's workplace clinic. The first dose was given at 08:30 on 06Jan2021. A few minutes after, the patient became dizzy and lightheaded for what seemed like a minute or two and then she was fine for the remainder of her 15-minute observation. Around 17:00 that day, the patient became itchy on her right arm and upper right torso area, no rash or swelling was noted. Itching subsided around 20:00 - almost 12 hours post-vaccine. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 06Jan2021 ("Itchy on her right arm and upper right torso area" at 20:00).
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| 36 | 2021-01-13 | headache, chills, malaise |
My first dose of COVID vaccine I didn't have any symptoms (1st dose: 12/23/20). Received 2nd dose at...
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My first dose of COVID vaccine I didn't have any symptoms (1st dose: 12/23/20). Received 2nd dose at 0800 on 1/12/21. First symptom was on 1/12 at 2000 when I had a headache and malaise so I went to bed early. Woke up at 0200 on 1/13 with nausea, body aches and chills. My temp felt fever-ish (100.4 via temporal scan). So I took Tylenol and Pepto to go back to sleep. Same symptoms carried throughout the morning of 1/13. By noon 1/13 = my L arm where the injection had occurred was swollen, painful and hard to move. That evening I had a presyncopal event where I felt flushed and nearly passed out. My L arm continued to hurt but the swelling moved down into my lymph nodes where lymphadenopathy continues to be a problem until now.
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| 36 | 2021-01-13 | dizziness | Nausea and dizziness. Gave me meclizine for vertigo |
| 36 | 2021-01-13 | headache, fever |
Nose bleed x 2 on 1/13/21. Fever 100.5, HA, Body aches, stomach pain, tachycardia. Treatment Ibuprof...
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Nose bleed x 2 on 1/13/21. Fever 100.5, HA, Body aches, stomach pain, tachycardia. Treatment Ibuprofen and Tylenol outcome: Mild improvement.
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| 36 | 2021-01-13 | fatigue, cold sweat, throat pain, headache |
Patient reports mild body aches, cold sweats and fatigue. Also a mild sore throat and slight headach...
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Patient reports mild body aches, cold sweats and fatigue. Also a mild sore throat and slight headache
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| 36 | 2021-01-13 | fatigue |
Pfizer Vaccine First dose - 12/19/2020 Mild soreness to arm, fatigue Second dose - 1/8/2021 AM of 1...
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Pfizer Vaccine First dose - 12/19/2020 Mild soreness to arm, fatigue Second dose - 1/8/2021 AM of 1/10/2021 had small patch of hives on ankle, took zyrtec resolved 1/11/2021 felt ok no symptoms 1/11 to 1/12 night "woke up and had massive allergic reaction everywhere - patches of redness on leg, arms, belly, back, face-sparing" -- took zyrtec and the reaction improved somewhat. Was in clinic so went up stairs and spoke to our dermatologist who thought this was likely reaction to vaccine. Prednisone RX given but has not taken. Takes 1-2 zyrtec daily. Spoke to me on the phone 1/12 at night, increased zyrtec to 4 pills daily, added pepcid and decided to speak today. Did not take atarax or benadryl bc she was on call. Improves with triamcinolone Presents today with worsening rash, she will upload pics in Epic. Areas of urticarial patches from yesterday now have left non blanching purple rash/bruising. More urticarial plaques today. No angioedema. Feels hot has not take temperature. No joint pain or swelling. No oral or vaginal mucosal involvement. No issues with respiration generally but maybe a little tight. >75% BSA involved Allergy history - chronic rhinitis, no known triggers or patterns No history of asthma, eczema, food allergy or drug allergies
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| 36 | 2021-01-13 | chills |
Pfizer-BioNTech COVID-19 Vaccine Patient described immediate jaw clenching/tightness within first ...
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Pfizer-BioNTech COVID-19 Vaccine Patient described immediate jaw clenching/tightness within first 10 minutes after vaccine, that only now subsided about 72-80 hrs later. Along with this severe body aches, soreness, chills.
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| 36 | 2021-01-13 | weakness, fever, sweating, fatigue, chills | Rigors, fever , body pain, chills, diaphoresis, fatigue, weakness .lymphadenopathy left axilla |
| 36 | 2021-01-13 | headache | Severe frontal headache for 48 hours |
| 36 | 2021-01-13 | headache, chills, weakness, fever, fatigue |
Severe headache in back of lower head/neck and frontal head, fever up to 101 degrees F, chills and r...
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Severe headache in back of lower head/neck and frontal head, fever up to 101 degrees F, chills and rigors, muscle pain, extreme weakness and fatigue. Affected my ability to function. Took Tylenol. Took almost 48 hours to recover.
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| 36 | 2021-01-13 | body temperature increased |
Swollen injection site with higher temperature and swollen surrounding lymph nodes in arm and undera...
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Swollen injection site with higher temperature and swollen surrounding lymph nodes in arm and underarm
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| 36 | 2021-01-13 | body temperature increased, chills |
Symptoms - ? EE reports around 5:00 PM began with arm soreness near injection site, at 8:00 PM +lowe...
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Symptoms - ? EE reports around 5:00 PM began with arm soreness near injection site, at 8:00 PM +lower back pain, 10:00 PM + body aches and chills, midnight: temp 99.6. Last day of work and shift - ? unsure, EE reported did not work yesterday or today; next scheduled shift tmw Home remedies? - Tylenol 500 mg at midnight and 0600 on 1/14/21 Any improvement? ? mild improvement Recommendation? EE encouraged to continue to monitor her symptoms and to contact the vaccine support line for further questions or concerns. EE encouraged to rotate Tylenol 500 mg and motrin 400 mg q3h for body aches, EE verbalized back understanding. EE educated to continue to manage per TCH Illness in the Workplace Policy. EE verbalized back understanding and denied further questions at this time.
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| 36 | 2021-01-13 | sweating, skin warm, fatigue, headache |
Symptoms started approximately 16 hours after receiving the vaccine. Body aches all over including b...
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Symptoms started approximately 16 hours after receiving the vaccine. Body aches all over including breast, under arms, legs, feet stomach. Horrible headache that did improve with tylenol and ibuprofen taken at the same time. Body shakes and can't control body temperature. Felt freezing cold but skin was very hot to the touch (according to my husband). Then, I started sweating and felt really hot and couldn't cool down. Felt nauseous but no vomiting. Could not sleep but felt very tired. Today is now 48 hours after vaccine and body aches are gone but I am still extremely fatigued.
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| 36 | 2021-01-13 | headache, dizziness, fatigue |
The night after receiving the vaccine (approximately 17 hours post-dose), I got up to use the restro...
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The night after receiving the vaccine (approximately 17 hours post-dose), I got up to use the restroom. While washing my hands I became extremely dizzy, hot and nauseous. While bending over to open the toilet (so that I could vomit) I ended up passing out. I woke up on the floor of my bathroom (with my head against the wall), somewhat disoriented, shortly thereafter (exact timeframe that I was "down" is unknown). I tried to get up and get back to bed but became extremely dizzy and hot again - this time bringing myself back down to the floor. I laid there for an unknown amount of time before feeling like I could try to move again. Once I felt a little better I crawled back to bed and laid down. I believe I was out of bed for a total of 15-20 minutes. I had no further dizzy/hot/nauseous episodes after that, however for the remainder of that day I felt exhausted, had a mild headache and felt like I couldn't get warm. I did not take my temperature. At about the 48-hr mark post-vaccination I was feeling back to normal other than a slight headache.
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| 36 | 2021-01-13 | headache, fever |
Vaccinated Thursday morning, later in the evening felt achy and had a fever. Headache for 2 days. Sa...
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Vaccinated Thursday morning, later in the evening felt achy and had a fever. Headache for 2 days. Sat morning 1/9/21 woke up with left arm weakness and numbness which went up to her face. Had an MRI completed which showed a new small right paritial ischemic stroke.
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| 36 | 2021-01-13 | headache |
Vaccine received Monday 04Jan, severe headache afterwards. Tuesday 05Jan, full body itchy rash. Unch...
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Vaccine received Monday 04Jan, severe headache afterwards. Tuesday 05Jan, full body itchy rash. Unchanged with use of benadryl.; Vaccine received Monday 04Jan, severe headache afterwards. Tuesday 05Jan, full body itchy rash. Unchanged with use of benadryl.; This is a spontaneous report from a contactable healthcare professional. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date not reported), via an unspecified route of administration in the left arm on 04Jan2021 14:00 at a single dose for COVID-19 immunisation. Medical history included depression and celiac disease. Concomitant medications included sertraline hydrochloride (ZOLOFT), omeprazole, calcium, and lactobacillus acidophilus (ACIDOPHILUS). The patient previously took amoxicillin, gluten and experienced allergies. It was reported that the patient had a vaccine received on Monday 04Jan2021, and experienced severe headache afterwards. On Tuesday 05Jan2021, the patient experienced full body itchy rash. These were unchanged with the use of Benadryl. Clinical outcome of the events was not recovered.
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| 36 | 2021-01-13 | fever, chills | fever, chills, nausea. called in sick to work. |
| 36 | 2021-01-13 | fatigue, cough |
got the covid 19 vaccine on 21Dec2020 and tested positive for covid on 24Dec2020; got the covid 19 v...
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got the covid 19 vaccine on 21Dec2020 and tested positive for covid on 24Dec2020; got the covid 19 vaccine on 21Dec2020 and tested positive for covid on 24Dec2020; This is a spontaneous report from a contactable Nurse (patient) from a Pfizer-sponsored program Pfizer First Connect. A 36-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via intramuscular in left deltoid on 21Dec2020 10:00 at 0.3 ml, single for precaution as front line healthcare worker in hospital which is not a military facility. Medical history included nonsmoker. She did not provide causality but stated that she probably already had COVID when she got the vaccine. It was unknown if the patient had SARS-CoV2 antibodies at diagnosis as she had never been tested. Other history was none. The patient did not have a history of hypertension, diabetes, heart disease, lung disease, liver disease, kidney disease, cancer, immunosuppressive disorder, obesity. There was not any pre-existing diseases worsened during the SARS-CoV2 infection. The patient hadn't been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Concomitant medication included bupropion hydrochloride (WELLBUTRIN SR), sertraline hydrochloride (ZOLOFT), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Prior Vaccinations (within 4 weeks) were none. AE following prior vaccinations were none. There was no additional vaccines administered on Same Date (21Dec2020) of the Pfizer bnt162b2. The patient got the covid 19 vaccine on 21Dec2020 and tested positive for covid on 24Dec2020. The patient wanted guidance on receiving the 2nd dose of the vaccine. The reporter considered event was non-serious. The patient received the first dose of the vaccine on 21Dec2020, and after that on 24Dec2020, she tested positive for COVID . She was supposed to be revaccinated on 07Jan2021. She would like to know if she should she get this or does she need to be revaccinated. There is no prescriber. She received it through her work. She received the first dose on 21Dec2020, and assumed she was positive when she got it. She just had cough and muscle aches and a headache. Her dad was hospitalized. Hers was not that serious. She had not completely recovered yet. Her smell had not come back yet and she was just tired still. She said the headache was prior to getting vaccine. She did not provide causality but stated that she probably already had COVID when she got the vaccine. The cough occurred on 25Dec2020, muscle aches on 22Dec2020 at 08:00. There was no emergency room of or physician's office required for the events. The patient was not hospitalized or admitted to an ICU. Nasal swab test done. Imaging for COVID-Pneumonia, other radiological investigations, hematology, clinical chemistry, inflammatory markers, urinalysis, evidence of hypoxemia, other relevant test were none. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient did not receive any additional therapies for COVID-19. The event did not require the initiation of new medication or other treatment or procedure. She did start taking extra vitamins on her own. The patient was recovered with some lasting effects such as not being able to smell and is tired still.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID with symptoms and the administration of COVID 19 vaccine, bnt162b2. However, as the reporter claimed "she probably already had COVID when she got the vaccine", this may provide an alternative explanation.
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| 36 | 2021-01-14 | fever, chills |
13 hours after the injection developed chills, myalgia, fever, rigors. Also local muscle pain at in...
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13 hours after the injection developed chills, myalgia, fever, rigors. Also local muscle pain at injection site. Systemic symptoms of fever (up to 101.4F), and myalgia resolved within 24 hours (about 36 hours since the injection). Also developed left axillary lymphadenopathy within 24 hours, which is improving but still some lymph node ttp present after 7 days
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| 36 | 2021-01-14 | headache, fever, dizziness, fatigue |
After 12hrs of covid vaccine 2nd shot i feel dizzy and tired/fatigue then feeling cold,feverish and...
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After 12hrs of covid vaccine 2nd shot i feel dizzy and tired/fatigue then feeling cold,feverish and having body aches and headache.i just rest in bed and took advil that night and tylenol on the 2nd day.until now on and off feeling fatigue,body aches, headache and fever.
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| 36 | 2021-01-14 | fatigue |
Arm pain, extreme fatigue and body aches upon waking the morning after the 2nd vaccination 1/14/21. ...
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Arm pain, extreme fatigue and body aches upon waking the morning after the 2nd vaccination 1/14/21. Fatigue and body aches lasted the entire next day and resolved by the morning 1/15/21. No fever
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| 36 | 2021-01-14 | chills, headache |
Chills; headache; diarrhea; vomiting; body ache; received second dose BNT162B2(lot number EI1283) , ...
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Chills; headache; diarrhea; vomiting; body ache; received second dose BNT162B2(lot number EI1283) , intramuscular at Arm Left on 08Jan2021; received second dose BNT162B2(lot number EI1283) , intramuscular at Arm Left on 08Jan2021; This is a spontaneous report from a contactable Nurse(patient). A 36-Year-old female patient received second dose BNT162B2(lot number EI1283) , intramuscular at Arm Left on 08Jan2021 19:00 at the 36 years old at single dose for COVID-19 immunization. The medical history included Asthma and Dm(Diabetes mellitus). The patient was not Allergies to medications, food, or other products. There were concomitant medications but unspecified. The patient previously took first dose BNT162B2 (lot numberEJ1685) on 21Dec20200 6:30 PM at 36 years old Intramuscular at Left arm for COVID-19 immunization. The patient experienced Chills, headache, diarrhea, vomiting, body ache on 09Jan2021 02:30 AM. It was unknown if there was treatment received for the adverse events Chills, headache, diarrhea, vomiting, body ache. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. The information on the batch number has been requested.
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| 36 | 2021-01-14 | malaise, fatigue |
Fatigue, malaise, and mild body aches from about 12 hours to 36 hours post vaccine. Then, starting a...
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Fatigue, malaise, and mild body aches from about 12 hours to 36 hours post vaccine. Then, starting about 4 days post vaccination, noted 2 enlarged (1-2cm) right axillary lymph nodes and 1 tender 2-3cm enlarged supraclavixular lymph node. These lymph nodes are on the same side and area that the vaccine was received. It is 7 days post vaccine and the nodes persist but are less tender.
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| 36 | 2021-01-14 | fatigue, shortness of breath, headache, dizziness |
First approximately 5 hours after receiving vaccine, patient experienced headache and moderate to se...
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First approximately 5 hours after receiving vaccine, patient experienced headache and moderate to severe site pain. approximately 12 hours post vaccine, patient experienced nausea, dizziness, fatigue, headache. 3 hours following, patient continued to have the same symptoms along with mild shortness of breath and tachycardia with mild to moderate exertion, such as walking up a flight of stairs.
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| 36 | 2021-01-14 | fatigue, headache | Headache within 15 minutes; fatigue 2-3 hours later, soreness at injection site for 2-3 days |
| 36 | 2021-01-14 | fatigue, headache |
Headache; muscle pain; fatigue; pain at injection site; This is a spontaneous report from a contacta...
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Headache; muscle pain; fatigue; pain at injection site; This is a spontaneous report from a contactable nurse. A 36-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), intramuscular on 08Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19. Vaccine location was left arm. Concomitant medication included topiramate (TOPAMAX), bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE), escitalopram oxalate (LEXAPRO), clonazepam (KLONOPIN). The patient experienced headache, muscle pain, fatigue, pain at injection site all on 09Jan2021. The events outcome was recovering Information on the lot/batch number has been requested.
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| 36 | 2021-01-14 | fatigue, chills, weakness, night sweats, sweating |
My face went numb, that was the first symptom 10/15 min after immunization. I got tachycardia (I ten...
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My face went numb, that was the first symptom 10/15 min after immunization. I got tachycardia (I tend to have a rapid hart beat but this was pumping pretty good). I also had some GI distress (watery diarrhea) and that lasted for a while. Later I got really weak and shaky, fatigued, that night I woke up with night sweats, and chills, woke up completely drenched, I had to change the sheets and pajamas. 5 days after the vaccine I was really exhausted, the fatigue was awful. There was also an itching sensation but no hives.
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| 36 | 2021-01-14 | fatigue |
Nausea/vomiting and fatigue began at approx. 3pm the following day (about 30 hours following injecti...
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Nausea/vomiting and fatigue began at approx. 3pm the following day (about 30 hours following injection), treated with rest and Zofran, lasting about 24 hours. Also decreased appetite. Muscle aches and pains began morning of 14 Jan 2021, approx. 46 hours following injection, treated with extra strength Tylenol and rest, lasting about 24 hours. As of 15 Jan 2021, currently no more adverse reactions.
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| 36 | 2021-01-14 | dizziness |
Not dizzy, but disconnected. On a boat feeling. Could not walk straight, weaving. No treatment. Pass...
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Not dizzy, but disconnected. On a boat feeling. Could not walk straight, weaving. No treatment. Passed after a few minutes on its own.
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| 36 | 2021-01-14 | throat irritation, fatigue |
Patient reports that approximately one hour after receiving the second dose of the vaccine she began...
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Patient reports that approximately one hour after receiving the second dose of the vaccine she began to feel fatigued. The following morning, at 6:30 a.m., she awoke with orbital edema, chest tightness, and an itchy throat. The patient sought emergent care at Emergency Center and received Solumedrol IV, Benadryl IV, and 1 Liter of Normal Saline IV. The patient reports almost immediate relief after receiving medication.
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| 36 | 2021-01-14 | dizziness, weakness, shortness of breath |
Symptoms started around 2300 on 01/14/2021. I experienced SOB; sharp and shooting pain throughout m...
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Symptoms started around 2300 on 01/14/2021. I experienced SOB; sharp and shooting pain throughout my extremities; dull body aches; nausea induced vomiting; dizziness; weakness. I was unable to sleep throughout most of the night. I used tylenol and ibuprofen for my symptoms which didnt seem to alleviate any of the symptoms during the night. Woke up on 01/15/2021 with a rash on my face.
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| 36 | 2021-01-15 | chills, headache, fatigue | Chills, headache, sore arm, tired |
| 36 | 2021-01-15 | fatigue, fever, chills, headache | Severe chills Fever 102.8 Body aches Fatigue Headache Metallic taste for days |
| 36 | 2021-01-15 | fatigue |
Soreness at injection site, fatigue, body aches and tenderness/swelling at lymph node near collar bo...
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Soreness at injection site, fatigue, body aches and tenderness/swelling at lymph node near collar bone on same side as injection site.
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| 36 | 2021-01-16 | fever, fatigue, headache | Arm soreness, body aches, headache, fever of 99.6, fatigue |
| 36 | 2021-01-16 | fatigue, headache, chills, fever |
At about 12 hours after the second dose I had chills, headache, fever of 101, fatigue and nausea. It...
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At about 12 hours after the second dose I had chills, headache, fever of 101, fatigue and nausea. It lasted for about 24 hours. My arm was also sore for about 72 hours after the shot. I did not have any reaction from the first dose except for a sore arm.
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| 36 | 2021-01-16 | dizziness |
Patient developed feeling of "burning in mid-chest" and palpitations 15 minutes after COVID vaccine ...
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Patient developed feeling of "burning in mid-chest" and palpitations 15 minutes after COVID vaccine administered. She also experienced intermittent tingling in hands and feet. Patient was evaluated by EMS in the vaccine clinic. The chest symptoms were episodic, occurring every 5 minutes and lasting 1-2 minutes with each episode. Intermittent dizziness also occurred during the chest-discomfort symptoms. Vital signs were stable and oxygen saturation was 100% on room air. Patient denied SOB, stridor and no labored breathing. Patient was transported to the hospital emergency department for further evaluation/observation. After 2 hours of observation, patient's symptoms resolved spontaneously. She discharged from the emergency department to home with family.
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| 36 | 2021-01-17 | headache | Body pain, headache, difficulty swallowing |
| 36 | 2021-01-17 | dizziness | Tachycardia, lighthead, dizzy |
| 36 | 2021-01-17 | fatigue, head discomfort |
Tonsillar and occipital Lymph node moderate swelling. Difficulty Swallowing. Stiffness in head and n...
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Tonsillar and occipital Lymph node moderate swelling. Difficulty Swallowing. Stiffness in head and neck. Profound fatigue. methylprednisoLONE (Medrol, Pak,) 4 mg tablet and azithromycin (Zithromax Z-Pak) 250 MG tablet mono test negative After 5 days on medications nodes size reduced, tenderness, stiffness, fatigue remain, but overall improved.
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| 36 | 2021-01-19 | headache, chills, cold sweat, migraine, fever |
1/7/21: MODERATE BODY ACHES AND MILD JOINT PAIN. 1/8/21 MORNING: SEVERE BODY ACHE, CHILLS, JOINT PAI...
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1/7/21: MODERATE BODY ACHES AND MILD JOINT PAIN. 1/8/21 MORNING: SEVERE BODY ACHE, CHILLS, JOINT PAIN, LOW GRADE FEVER (99.8) AND SEVERE HEADACHE. SWOLLEN FACE AND ARM PAIN. 1/8 NIGHT: HIGH GRADE FEVER (101.4). 1/10: HIGH GRADE FEVER (101.3 REACHING HIGHEST OF 102.9). SEVERE BODY ACHES, CLUSTER HEADACHE/MIGRAINE, JOINT PAIN. CILLS, COLD SEATS, LOSS OF APPETITIE, NAUSEA. SWOLLEN FACE AND ARM PAIN. 1/11 MORNING: LOW GRADE FEVER, MODERATE BODY ACHES, CHILLS AND COLD SWEATS, NAUSEA (STRONGER), LOSS OF APPETITE AND STOMACH ACHE, DIARRHEA, AND ARM PAIN. 1/11 AFTERNOON AND NIGHT: MODERATE STOMACH ACHE, NAUSEA. 1/12: STILL MILD NAUSEA AND LOSS OF APPETITE, ARM PAIN. TOOK IBUPROFEN, TYLENOL.
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| 36 | 2021-01-19 | headache, chills, fatigue |
11 hours after the second Pfizer Covid dose I started experiencing fatigue, mental cloudiness, and n...
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11 hours after the second Pfizer Covid dose I started experiencing fatigue, mental cloudiness, and neck pain. Around 18 hours post vaccine I had sever body aches, headaches, and chills. I have had to take extra strength Tylenol and Motrin to combat the symptoms.
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| 36 | 2021-01-19 | fatigue, fever | Arm pain, body muscle aches, fever, fatigue. 48 hours |
| 36 | 2021-01-19 | weakness, headache |
Developed symptoms the evening after vaccine administered. Sx included: nausea, vomiting, diarrhea, ...
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Developed symptoms the evening after vaccine administered. Sx included: nausea, vomiting, diarrhea, weakness, body aches, headache, decreased appetite. Symptoms significantly improved after 3-4 days
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| 36 | 2021-01-19 | fatigue, headache |
Red, swollen, painful, injection site beginning the evening after the second dose. Fatigue a few hou...
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Red, swollen, painful, injection site beginning the evening after the second dose. Fatigue a few hours after the second dose. The fatigue continued through the second day after the dose. Headache the day after the second dose. All symptoms were treated with ibuprofen.
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| 36 | 2021-01-19 | chills, fever, migraine |
The following day @1:30pm on 1/18/21 I started feeling achy like I had a fever, chills, pains in my ...
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The following day @1:30pm on 1/18/21 I started feeling achy like I had a fever, chills, pains in my body all through the night. This morning on 1/20/21 I had a horrible migraine that lasted till 3:30pm. All the symptoms went away by 4:30pm
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| 36 | 2021-01-19 | weakness, fatigue, headache, fever | fever, headache, weakness/ fatigue |
| 36 | 2021-01-19 | night sweats |
sinus arrhythmia; Night sweats; Heart rate low; Dyskinesia; This is a spontaneous report from a cont...
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sinus arrhythmia; Night sweats; Heart rate low; Dyskinesia; This is a spontaneous report from a contactable nurse (patient). This 36-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at single dose in the left arm on 07Jan2021 10:00 for covid-19 immunisation. Medical history included hypotension, rheumatoid arthritis, asthma. Concomitant medication included clonazepam, methylprednisolone. On 07Jan2021 21:00, the patient experienced sinus arrhythmia, night sweats, heart rate low, dyskinesia, all with outcome of recovered with sequelae. Therapeutic measures were taken as a result of the events included Inderal 10mg. The events were assessed as congenital anomaly. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 36 | 2021-01-20 | fatigue, headache, chills, throat pain |
Fatigue; Chills; Headache; Nausea; Vertigo; Sore throat; This is a spontaneous report from a non-con...
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Fatigue; Chills; Headache; Nausea; Vertigo; Sore throat; This is a spontaneous report from a non-contactable other Health Care Professional (HCP). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date unknown), intramuscularly, on 04Jan2021 at 10:00 AM (at the age of 36 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. No allergy information was reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Jn2021, the patient experienced fatigue, chills, headache, nausea, vertigo and sore throat. The events resulted in a physician office visit. Treatment information was not provided. The patient underwent lab tests and procedures which included sars-cov-2 test on an unspecified date after the vaccination the result of which was negative. The clinical outcomes of fatigue, chills, headache, nausea vertigo and sore were reported as recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 36 | 2021-01-21 | fever, runny nose, chills |
After my second vaccine on 1/12 at approximately 0730am I developed fever and chills around 1100pm t...
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After my second vaccine on 1/12 at approximately 0730am I developed fever and chills around 1100pm that same day. I had these symptoms through 0800am on 1/13. I was recovered from these symptoms on 1/14. However, by the evening of 1/15 I developed some sinus-related symptoms like sneezing and runny nose. On 1/16 I could not taste or smell anything. I got a PCR COVID test on 1/17 and have not developed any additional symptoms. My sinus related symptoms resolved after 1/17. As of today, 1/22, my PCR results have come back positive.
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| 36 | 2021-01-21 | fatigue |
After the first dose 12/30/2020, I experienced significant fatigue and increased joint pain the foll...
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After the first dose 12/30/2020, I experienced significant fatigue and increased joint pain the following 2 days. Hours after receiving the second dose, I experienced vomiting, nausea, fatigue, severe joint pain. I was unable to stay at work or work at all the following day. I slept almost the whole time. At 2 days later, I still have significant joint pain and moderate fatigue.
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| 36 | 2021-01-21 | cough, shortness of breath |
Approximately 3 hours after the injection, a cough with wheezing began. This worsened over the cour...
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Approximately 3 hours after the injection, a cough with wheezing began. This worsened over the course of 15 minutes which began to increase the labor of breathing. Fortunately, I had a left over albuterol inhaler (pro air respiclick) from a respiratory illness a few years ago. Administered 2 metered doses with near immediate resolution. No further symptom recurrence.
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| 36 | 2021-01-21 | headache, fever, fatigue |
Feeling febrile, headache, severe body aches, fatigue, joint pain and weakness in arm shot was given...
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Feeling febrile, headache, severe body aches, fatigue, joint pain and weakness in arm shot was given (lasted the longest)
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| 36 | 2021-01-21 | fatigue |
Nausea Vomiting Fatigue Muscle aches Joint aches Swollen Lymph nodes in both armpits; more severe sw...
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Nausea Vomiting Fatigue Muscle aches Joint aches Swollen Lymph nodes in both armpits; more severe swelling on injection side.
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| 36 | 2021-01-21 | fatigue, headache, discomfort |
Pt received first Covid Pfizer vaccine this evening and during 15 minute wait time experienced left ...
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Pt received first Covid Pfizer vaccine this evening and during 15 minute wait time experienced left arm swelling, tingling and discomfort. Pt alert, oriented and denies any respiratory symptoms. Gave Benadryl 25 mg po at 1758 and pt states "50 mg makes me tired and I live out of town". Gave second dose of Benadryl 25 mg po at 1800 when pt began feeling "like my tongue is swelling". Contacted Med ER team to assist with monitoring. Removed pt rings and bracelets on left wrist/hand as pt states "feel like my whole arm is swelling". BP: 122/78 Rt. Arm with apical HR: 60/min and regular. Injection site Left deltoid is not red but swelling noted and spreading. Area is normal temp to touch. Tried ice bag to injection site left deltoid which made it feel worse per pt. The ice made the arm area red. 1818 BP: 136/90. Med team arrived and decision made to transport pt to ED for observation. Pt assisted to wheelchair for transport. Report given to RN from ED. Pt remained alert and oriented throughout. Pt contacted her family herself to notify. Pt received Solumedrol and Famotidine in the ED. Pt was observed and discharged within an hour. Pt follow up with Employee Health provider 1/22/21. Pt continues to experience intermittent rash/hives on chest/neck relieved by Benadryl, Headache, and entire left side feeling tingling and "weird".
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| 36 | 2021-01-21 | headache, fatigue | Severe headache and neck pain for two weeks. Tired and body ache Shingles on third week |
| 36 | 2021-01-24 | dizziness, runny nose |
Arm pain at injection site; Runny nose; Lightheaded; This is a spontaneous report from a non-contact...
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Arm pain at injection site; Runny nose; Lightheaded; This is a spontaneous report from a non-contactable physician, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 22Dec2020 (at the age of 36-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced arm pain at injection site, runny nose, and lightheaded. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of arm pain at injection site, runny nose, and lightheaded were unknown. No follow-up attempts are possible; information about lot number cannot be obtained.
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| 36 | 2021-01-24 | headache, fatigue, dizziness, migraine |
Day of vaccine: headache, sore arm. Day 2: migraine, eyes sore to touch, burning, extremely sensitiv...
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Day of vaccine: headache, sore arm. Day 2: migraine, eyes sore to touch, burning, extremely sensitive to light, dizzy, extremely tired. Day 3: headache, nausea, vomiting, diarrhea, dizzy, resting heat rate above 100, exhaustion. Day 4: shaky, dizzy, nauseous, resting heat rate not below 100 for several hours, heart palpitations, heart beating very hard at times, exhaustion.
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| 36 | 2021-01-24 | lethargy, cold sweat, fever | Fever, body aches, diarrhea, lethargic, cold sweats. |
| 36 | 2021-01-24 | chills, fatigue, headache, respiratory tract congestion | Rash at injection arm and trunk on that side of body, congestion and fatigue, chills and headaches |
| 36 | 2021-01-24 | fatigue, headache | headache, fatigue, muscle aches and nausea |
| 36 | 2021-01-25 | headache |
First dose only had a head ache; This is a spontaneous report from a non-contactable other HCP (pati...
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First dose only had a head ache; This is a spontaneous report from a non-contactable other HCP (patient). A 36-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number EK5730) , via an unspecified route of administration on 22Dec2020 09:15 at single dose on left arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported first dose only had a head ache on an unspecified date. She was fine the morning before receiving second dose. Patient was not pregnant. Patient did not have Covid prior vaccination and Covid was not tested post vaccination. Patient did not receive other vaccine in four weeks. No known allergies. The outcome of the event was resolved on an unspecified date. No follow up attempts are possible. No further information is expected.
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| 36 | 2021-01-25 | fatigue, chills, headache, fever |
Headache; fever; chills; joint pain; muscle pain; fatigues; This is spontaneous report from a contac...
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Headache; fever; chills; joint pain; muscle pain; fatigues; This is spontaneous report from a contactable other HCP. A 36-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 09:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient took the first dose on 23Dec2020 at arm left for covid-19 immunization. Medical history included asthma from an unknown date. Allergies to medications included Lamictal and Penicillin. There were no concomitant medications. The facility type vaccine was hospital. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache, fever, chills, joint pain, muscle pain, and fatigue on 11Jan2021 with outcome of not recovered. Patient didn't receive treatment for the adverse events. The events were reported as non-serious. Information on the batch number and lot number has been requested.
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| 36 | 2021-01-25 | chills | Joint pain all over my body and chills |
| 36 | 2021-01-25 | fever |
became tachycardic with heart rate of 105-130 bpm; slight fever; This is spontaneous report from a c...
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became tachycardic with heart rate of 105-130 bpm; slight fever; This is spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL3246, unknown expiration), intramuscular in right arm on 11Jan2021 at 09:15 at a single dose for COVID-19 immunization in a hospital. Medical history included migraine headaches. The patient has no known allergies. Concomitant medications included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN); zinc; colecalciferol (VITAMIN D); and vitamin c. About 12 hours after vaccine, the patient became tachycardic with heart rate of 105-130 bpm (Jan2021). This was accompanied by a slight fever (Jan2021). Heart rate is still slightly elevated at 90-100 bpm about 24 hours after vaccine. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient had not yet recovered from the event tachycardia, while unknown outcome for event slight fever.
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| 36 | 2021-01-25 | headache, fatigue |
fatigue; headache; injection site soreness; This is a spontaneous report from a contactable other he...
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fatigue; headache; injection site soreness; This is a spontaneous report from a contactable other health care professional. A 36-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0140), via an unspecified route of administration on 12Jan2021 16:00 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history included Idiopathic intracranial hypertension. On 12Jan2021 20:00, the patient experienced Fatigue, Headache, Injection site soreness. The patient did not receive treatment for the events. The outcome of the events was recovering.
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| 36 | 2021-01-25 | headache |
headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 36-year-old ...
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headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El 3248), via an unspecified route of administration in left arm on 09Jan2021 12:45 at single dose for COVID-19 immunization. Medical history included high blood pressure, asthma and shellfish, turmeric and antibiotics allergies; all from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (ADVIL), fexofenadine hydrochloride (ALLEGRA), hctz, montelukast sodium (SINGULAIR) and budesonide, formoterol fumarate (SYMBICORT). The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 11Jan2021 05:00 AM, 2 days later from the vaccination, the patient experienced nausea and headache. No treatment was given to the patient for the events. The outcome of the events was not recovered.
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| 36 | 2021-01-26 | chills |
1/18/2021- injection right arm 1/19/2021- mild pain at injection sight. Body aches. 1/20/2021- mild...
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1/18/2021- injection right arm 1/19/2021- mild pain at injection sight. Body aches. 1/20/2021- mild pain and muscle stiffness at injection sight. Chills and body aches. 1/21/2021woke up with itching on left side of face a scalp. 1/22/2021 itching subsided 1/23/2021- left side face drooping started.
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| 36 | 2021-01-26 | dizziness |
6 Days after the vaccine I experience dizziness with passing out feelings, vertigo which lasted over...
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6 Days after the vaccine I experience dizziness with passing out feelings, vertigo which lasted over seven days, chest pain?s, heart palpitations
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| 36 | 2021-01-26 | headache, fever, chills |
Chills on the evening of injection. The next day 1/26/21 - 100.2 fever, headache, body aches- 600mg...
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Chills on the evening of injection. The next day 1/26/21 - 100.2 fever, headache, body aches- 600mg of ibuprofen taken once around 8 AM. Fever and body aches improved post ibuprofen, headache persisted. Evening of 1/26/21 fever seemed to return at 99.1 but resolved the morning of 1/27/21. Injection site reaction of warm, red, slightly raised bump noted on the AM of 1/27/21- no action taken at this time
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| 36 | 2021-01-26 | chills, headache | HA, GI SYMPTOMS, CHILLS |
| 36 | 2021-01-26 | cough |
I have had severe lymph node swelling on the right side where I got the vaccine; 24hrs post 2nd vacc...
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I have had severe lymph node swelling on the right side where I got the vaccine; 24hrs post 2nd vaccination I have had a sudden onset of an extremely violent cough; My sputum is greenish/yellow brown with blood flecks; My sputum is greenish/yellow brown with blood flecks; chest tightness; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular in the right arm on 11Jan2021 15:45 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, asthma, polycystic ovarian syndrome (PCOS), endometriosis, chronic allergies, gastritis, and walnut allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), metformin, loratadine (CLARITINE), spironolactone, and calcium carbonate, colecalciferol (VITAMIN D 2000). The patient previously took first dose of bnt162b2 (lot number and expiry date not reported), intramuscular in the right arm on 21Dec2020 15:15 at single dose for COVID-19 immunisation. The patient verbalized, "I don't know if it's related but I figured I should report just in case. I have had severe lymph node swelling on the right side where I got the vaccine. 24hrs post 2nd vaccination I have had a sudden onset of an extremely violent cough. By sudden onset, I mean I had no desire to cough and over about 30 min I developed the severe need to cough. My sputum is greenish/yellow brown with blood flecks. I've never experienced such a violent cough with so much sudden sputum production. I am using an Albuterol inhalor to help chest tightness." Clinical outcome of chest discomfort was unknown while for the other events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on a close chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 36 | 2021-01-26 | dizziness | Itching of chest and arms, Redness at injection site, Lightheaded 15min after vaccine |
| 36 | 2021-01-26 | headache |
Pfizer-BioNTech COVID-19 Vaccine EUA Arm soreness the evening of injection and the following day. H...
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Pfizer-BioNTech COVID-19 Vaccine EUA Arm soreness the evening of injection and the following day. Headache the night of injection
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| 36 | 2021-01-26 | chills, throat pain, fever, headache | REPORTS FEVER, CHILLS, HEADACHE, SORE THROAT, AND VOMITING |
| 36 | 2021-01-26 | skin warm | Red hot half dollar size painful lump, went away came back as red itch half dollar size lump. |
| 36 | 2021-01-26 | chills, dizziness |
Second day after vaccine had joint pain and chills third and 4 day stomachache. 1 week after started...
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Second day after vaccine had joint pain and chills third and 4 day stomachache. 1 week after started having neck pain on my left side until now and irradiate toarse my shoulder and arm p to my hand on left side also random days present dizziness when I lie down blurry vision. on January 19 had neck pain shoulder pain and headaches on left side too went to Dr. and his medical diagnosis was muscle spasm might be induce due to stress pre-scribe Diazepam 5 mg . start taking it on Wednesday January 20-2021 but Saturday January 23 my upper lip started getting swollen , IL STOP THE MEDICATION ON MONDAY JANUARY 27 LIPS got better but still filling burning sensation inside mucosa on left side of the lip. still mild swollen started taking Zyrtec my concern is second doses of Pfizer vaccine is this Friday 29 should I get it or wait ?? what I Have could be effects from first Dose??.
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| 36 | 2021-01-26 | fatigue, dizziness, headache, fever |
right armpit and axilla swelling, pain in lymphnodes; right armpit and axilla swelling, pain in lymp...
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right armpit and axilla swelling, pain in lymphnodes; right armpit and axilla swelling, pain in lymphnodes; headache; fever; fatigue; Vomit; Dizzy; rash not sure first time but within first 12 hours over chest and trunk; This is a spontaneous report from a contactable other HCP. This other HCP reported for herself that a 36-year-old female patient received second dose (lot number: Ek9231) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 36-years, on 08Jan2021 19:00 (07:00 PM) at single dose in right arm; first dose (lot number: Eh9899) on 18Dec2020 07:00 PM at single dose; both via unspecified route of administration for COVID-19 immunisation in hospital. Medical history included thyroid issues; allergies to latex and adhesives. No COVID prior vaccination. No other vaccine in four weeks. Patient is not pregnant. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA). The patient previously took thimerosal and experienced allergy to it. On 08Jan2021, the patient experienced vomit and dizzy within 1 hour of vaccine. Rash not sure first time but within first 12 hours over chest and trunk. On 09Jan2021 (next day) headache, dizzy, fever, fatigue. On 11Jan2021 (after 2 days), right armpit and axilla swelling, pain in lymphnodes. It was unknown if treatment was received or not. The events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. No COVID-19 tested post vaccination.
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| 36 | 2021-01-27 | fever, chills, fatigue |
Pericarditis :severe, pleuritic chest pain, with subtle T-wave inversions, mildly elevated troponin,...
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Pericarditis :severe, pleuritic chest pain, with subtle T-wave inversions, mildly elevated troponin, elevated CRP and ESR-- developed symptoms approx 50-54 hours after immunization) Also had 36 total hours of severe arthralgias, myalgias, fatigue, fevers and chills.
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| 36 | 2021-01-28 | malaise, dizziness, shortness of breath, fatigue, thirst |
feels tired; heart rate became very fast, it went into like the 150's; feeling jittery; Lightheadedn...
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feels tired; heart rate became very fast, it went into like the 150's; feeling jittery; Lightheadedness; weakness of lower extremities; Nauseated; felt really cold; probably had a fever; really thirsty; very hot; she wasn't feeling well; This is spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular (deltoid left) on 14Jan2021 18:25 at 0.3 mL, single for Covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took Bactrim and experienced allergy. The patient reported she did develop some side effects, but the hospital she received the vaccine at didn't know if it was an allergic reaction or what. She reported that a minute or two minutes after receiving the COVID-19 vaccine (14Jan2021), her heart rate became very fast, it went into like the 150's. She started feeling jittery, lightheaded, and she had some weakness of her lower extremities. She also felt nauseated. She didn't have any shortness of breath; she thinks she was okay there. She clarified that she had her mask on and they told her to remove her mask and to breathe, breathe, breathe. She had a pulse oximeter on, and her levels were always at 98, 96. She was told to sit still, and she was given water. Her heart rate went down to 76. She was fine and then after 5 minutes, she had the same reaction again. Her heart rate this time was in the 120's. She was lightheaded, cold, jittery. She did the same thing again and waited another 5- 10 minute. She felt better but was still nauseated, lightheaded, and really, really cold. She was kept there for 45 minutes. After that, she still did not feel 100%. Currently, she still does not feel 100% well. She was okay, she thinks she was okay. She explains they wanted to send her to the ER (emergency room) but she declined. Her heart rate had improved, she wasn't feeling like she was going to pass out. She wasn't experiencing shortness of breath, she wasn't throwing up, she didn't have a rash, her throat wasn't closing up, so she went back to work. She further stated that she came back home. Her heart rate was a little faster, but it wasn't as high as it had been. She still felt a little bit of weakness. At night (14Jan2021), she probably had a fever, she doesn't know. She was really thirsty and very hot. Because she was not feeling well, she didn't get up and drink anything. This morning (15Jan2021), she feels a little better. If she is doing her normal activities, she does get tired. She feels like she is running and is like "okay I feel tired". She has a little bit of weakness in her lower extremities. She was given information for reporting side effects, but because she wasn't feeling well, she didn't do any of it. She checked her heart rate today (15Jan2021) and it's at 76. She added that when she moves a lot, she feels tired and she doesn't know why. She's normally a very active person. She is no longer jittery, but still feels lightheaded. She has a little bit of nausea. She felt hungry so she made a shake and it's not like she is going to throw up, but she is still feeling yucky. She still has a little weakness of her lower extremities. They feel light, she doesn't know how to explain it. She is just a little bit concerned because this is a new vaccine. The outcome of event heart rate increased was recovering; outcome of event feeling jittery was recovered on an unspecified date; while the outcome of other events was unknown. The patient confirmed he doesn't believe it to be life threatening. She doesn't know if this is a severe allergic reaction. She was reading on the side effects the COVID-19 vaccine can cause. Per reporter all events were related to suspect product.; Sender's Comments: Based on the compatible time association, the contribution of suspect BNT162b2 to the event heart rate increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 36 | 2021-01-28 | fatigue, fever, headache | headaches, myalgias, fatigue and fever |
| 36 | 2021-01-28 | fever, night sweats, fatigue, weakness |
night sweats; myalgia; weakness; fatigue; fever Hours; This is a spontaneous report from a contactab...
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night sweats; myalgia; weakness; fatigue; fever Hours; This is a spontaneous report from a contactable physician. This 36- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EK9231), via intramuscular route of administration, on 28Dec2020 at 01:00 pm (at the age of 36-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a workplace clinic and anatomically located on the left arm. The medical history was not reported. Concomitant medications included Levothyroxine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020 at 11:00PM, she experienced a "Fever hours", night sweats, myalgias, weakness and fatigue. The patient did not receive treatment for the events. The clinical outcome of the events "Fever hours", night sweats, myalgias, weakness and fatigue were recovered without treatment. On 31Dec2020, the patient was tested for COVID-19 via Nasal Swab since having the vaccine, with a negative result. No follow-up attempts are possible. No further information is expected.
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| 36 | 2021-01-28 | dizziness, fatigue, weakness |
tired; sore; thought that she would pass out; dizziness/felt dizzy; weakness/felt very weak; hard fo...
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tired; sore; thought that she would pass out; dizziness/felt dizzy; weakness/felt very weak; hard for her to talk/was having a hard time talking, like she had to put effort into talking; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Expiry Date: 31Mar2021, lot# EJ1685), intramuscularly in left arm on 31Dec2020 at 0.3 mL, single for COVID Prevention. Medical history included ongoing Hypertension/high blood pressure (Diagnosed about 2 years ago). Concomitant medication included ongoing ascorbic acid (VITAMIN C) and just some other vitamins but she does not think that is relevant. She had no other vaccines on the same day as the COVID vaccine. The patient experienced dizziness/felt dizzy, weakness/felt very weak, hard for her to talk/was having a hard time talking, like she had to put effort into talking, thought that she would pass out, all on 31Dec2020 with outcome of recovered on 31Dec2020, tired and sore on 02Jan2021 with outcome of recovered on 04Jan2021. The patient got the vaccine on 31Dec2020, and is scheduled to receive the 2nd dose next week and within a couple minutes after getting the vaccine, like less than 5 minutes later, she felt dizzy and very weak, and thought that she would pass out, and she was having a hard time talking, like she had to put effort into talking. After like an hour, she felt better. From then on, she had no side effects besides just being tired and sore, but she had no fever or anything like that. She does have hypertension in her history, but she hasn't been taking her pill because her BP has been stable. She felt like when she took the Pfizer Vaccine, some people can feel their BP shooting up, like it felt like a sensation in the back of head that her BP went up, but she did not think it was her BP because she has not needed to take her pill because her BP has been good. She did not take her BP, so she doesn't know what her BP was at the time. It was a pressure in the back of her like how she feels if her blood pressure is elevated. Investigation Assessment: No. Relatedness of drug to all the events was related per source of assessment: primary source reporter, method of assessment: global introspection.; Sender's Comments: Based on the compatible time association, the event depressed level of consciousness is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 36 | 2021-01-31 | chills, influenza like illness, fatigue |
Nausea Flu like symptoms- aches, chills, fatigue SEVERE RASH- all over body- red and inflamed ITCH...
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Nausea Flu like symptoms- aches, chills, fatigue SEVERE RASH- all over body- red and inflamed ITCHY- uncomfortable ER VISIT - Hospitalized Medicine- Prednisone, Zyrtec, Pepcid
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| 36 | 2021-02-01 | shortness of breath, throat swelling, cough |
After I have the Pfizer vaccine, with 15 minutes I started having a small cough. The cough increased...
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After I have the Pfizer vaccine, with 15 minutes I started having a small cough. The cough increased; my throat swollen; hard to breath; This is a spontaneous report from a contactable other hcp (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: El9261) at left arm via an unspecified route of administration on 22Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included known allergies: Apple, pear, peach, pineapple, mango, avocado and almonds. Concomitant medications included unspecified multivitamins. No other vaccine in four weeks. After patient had the bnt162b2, with 15 minutes she started having a small cough on 22Jan2021 15:15. The cough increased, her throat swollen and hard to breath on 22Jan2021 15:15. The nurse immediately gave her the epi pen and Benadryl. She had to rush to the ER. When she got there, she needed to have the second round of epi pen and more Benadryl. Events resulted in life threatening illness (immediate risk of death from the event). No covid prior vaccination. The patient was not pregnant at time of vaccination. The patient underwent lab tests and procedures, which included Nasal Swab on 25Jan2021 with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events cough, throat swelling and difficulty breathing. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 36 | 2021-02-01 | dizziness |
Facial flushing that was more prominent on the left side of my face and left ear flushing and burnin...
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Facial flushing that was more prominent on the left side of my face and left ear flushing and burning, dizziness, nausea., and rapid pounding heart beat. This started 45 minutes after receiving the vaccine. About 1 1/2 hours symptoms still persisted so took 50mg of Benadryl and slept for 2 hours. Upon waking up facial flushing, dizziness, and pounding heart rate still present but was better. Continued to have left sided cluster headache and face flushing for 48 hours. Also was sore in my left arm down my left side to the bottom of my rib cage all the way up my left neck and sore into my left chest.
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| 36 | 2021-02-01 | chills, headache, influenza like illness |
Flu like symptoms approximately 8 hours following. Chills, headache, body aches. Large, hard lump at...
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Flu like symptoms approximately 8 hours following. Chills, headache, body aches. Large, hard lump at injection site. 12 hours following vaccine, severe edema in Left Axilla. Multiple swollen lymph nodes and general edema. Unable to put arm down. Symptoms subsided after 48 hours, but are pain and mild swelling are still present.
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| 36 | 2021-02-01 | dizziness, shortness of breath, fatigue, malaise |
Started with some nausea around noon on 1/18 that resolved, then experienced nausea without emesis a...
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Started with some nausea around noon on 1/18 that resolved, then experienced nausea without emesis and palpitations while driving to work at 1800. She describes it as feeling like her heart was racing, but also feeling like she was having large pauses in her heart rate in between the palpitation sensations. She drank a bottle of water and the feeling went away temporarily but it returned. I am an employee, on arriving to work I noted increased shortness of breath which is unusual for me because I am an avid runner and very active. I noted the palpitations from around 1800-2000, including becoming dizzy and lightheaded during my shift which could endanger patient care, so I presented to the ED and was placed in the CCA. I had received both covid vaccines, second one on 1/11/21 and had about 20H malaise/fatigue and some expiratory wheezing which was abnormal for her but all has since resolved. I had intermittent heart palpitations and chest until 1/26
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| 36 | 2021-02-01 | headache |
Tested positive for COVID 1/23/21. Was asymptomatic at the time and was tested due to positive house...
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Tested positive for COVID 1/23/21. Was asymptomatic at the time and was tested due to positive household members. Developed symptoms (headache) 1/25/21. Developed sensation change (pins and needles) in left arm 1/31/21. Was seen in Emergency Room and kept overnight for observation. No obvious cause for symptoms was found.
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| 36 | 2021-02-02 | throat swelling, weakness, chills, dizziness, shortness of breath, malaise |
On Saturday had nausea, vomiting started, and progressively lead to dizziness, shortness of breath, ...
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On Saturday had nausea, vomiting started, and progressively lead to dizziness, shortness of breath, chest tightness, diarrhea, feeling of something stuck in her throat globus sensation, weakness. She went to the ER on 1/18/21 they felt she had gastritis and gave her fluids, Zofran and COVID test which was negative, then they sent her home. It continued where she could not eat, could not sleep, felt like she was going to die. She ended up going back to the ER again on 1/23/21. They did a CT scan, EKG, gave her IV fluids, flu and an antimotility agent for the nausea. They did lab work to rule out other tests. Did stool culture, blood work. She got admitted over night, then she had endoscopy on 1/24/21 to rule out any issues with her throat since she felt like it was closing on her. They said her esophagus looked fine, took biopsies. All the tests that were done were negative, and sent her home on 1/24/21. Then on Monday, 1/25/21 went to see a ENT specialist who also did a scope to loop down her throat to se if anything was blocked and felt that it was inflammation due to vomiting. Advised to take Proton pump inhibitor to help with the acid reflux from the vomiting. The GI doctor called on 1/26/21 showed some H-pylori, but did not know why she had that. Was started on antibiotics for that. She saw her PCP on 1/28/21, who did work up for celiac disease, thyroid scan/studies and all tests were negative as well. Right now she is home and the plan is to wait it out and to see if she gets better over time. She still having today 2/3/21 diarrhea, no appetite, cannot sleep, occasional chills, no fever, headache, chest tightness, nausea but is taking Zofran, still having the globus sensation in her throat. States her "body is not well", weakness as well.
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| 36 | 2021-02-03 | shortness of breath |
hives from the neck to legs; Face redness; tightness in the chest; unable to take a deep breathe; Th...
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hives from the neck to legs; Face redness; tightness in the chest; unable to take a deep breathe; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), intramuscular in left arm on 12Jan2021 11:00 to at a single dose for COVID-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On 12Jan2021 11:00, hives from the neck to legs, face redness and tightness in the chest, and was unable to take a deep breathe. The outcome of the events was recovered with sequelae. The events resulted in an emergency room/department or urgent care. Treatment for the events included Benadryl, Ativan, Pepcid, NS Bolus and EpiPen. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested with COVID-19 post vaccination.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of hives from the neck to legs, face redness and tightness in the chest, and was unable to take a deep breathe due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including physical examination with vitals and chest x-ray, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 36 | 2021-02-04 | shortness of breath, dizziness |
hives started to appear on her body/hives on her neck; nauseous/ was going to throw up; dizzy; diffi...
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hives started to appear on her body/hives on her neck; nauseous/ was going to throw up; dizzy; difficulty breathing (wheezing); difficulty breathing (wheezing); injection site soreness; She was hot, flush; difficulty swallowing; the tongue started swelling/Swollen tongue; Anaphylactic reaction/anaphylaxis; This is a spontaneous report from a contactable consumer reported for self. This 36-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Jan2021 12:52 left arm at single dose (Lot: EL3247) for covid-19 immunisation. Medical history included ongoing Anaphylaxis to Walnuts, Oranges, and morphine, ongoing allergy to a steroid cream Kenalog, and a steroid powder which she broke out immediately and ongoing Colitis. Concomitant therapy was none. She received the first dose of the vaccine yesterday on 20Jan2021 12:52 and 10 minutes later (20Jan2021 13:02) the tongue started swelling/Swollen tongue so they gave her Benadryl to try to stop it but it didn't help enough, hives started to appear on her body so they gave her a dose of epinephrine in the right arm and put on an IV, because she was feeling nauseous and dizzy. She started to feel better and was transferred to the hospital, when she was in the hall of the hospital she started having difficulty breathing (wheezing) and difficulty swallowing so she received another dose of Epinephrine (EpiPen) and also Benadryl, Prednisone and Pepcid. She went home and was taking Prednisone (1 daily), Benadryl and salbutamol (twice daily). She went into anaphylaxis within 15 minutes of receiving it on 20Jan2021. She brought 2 Epi injections with her. They monitored at the hospital for a few hours. She knows exactly how it happened. She was sitting in the observation room. She had told them multiple times that she had allergies before. She came in with two Epi pens and Benadryl. She let them know that as well. She was very verbal that she has history of anaphylaxis. They gave it to her. They said they were going to monitor her for 30 minutes. Her tongue started to swell 10 minutes after. She was sent to the paramedic tent. She took liquid children's Benadryl to try to stop the reaction. It did not help. She clarified it just didn't work enough to delay it. She doesn't have UPC, but provided the following information from the bottle: PLD-H242C LB004314 Lot WJ00896 Expiration Feb2023. She then started getting hives on her neck. She was hot, flush, and dizzy. She felt like she was going to throw up. That passed. They then gave her Epi in the opposite arm, her right arm. She got the COVID vaccine in her left arm. Then, they got her ready to go to the hospital. The transfer was smooth. She was waiting for intake when she started to not be able to swallow. She complained quickly. The nurses ran to get Epi, but the paramedic grabbed the patient's Epi pen and injected it in her thigh. She was IVed up at the vaccine center before transfer. They gave her Benadryl, Pepcid, and methyl prednisone. The Epi pen they gave her was her own shot. They monitored her a few hours. Then sent her home with Pepcid, more Epi pens, and Prednisone for 4 days. She has had normal soreness in her arm at the injection site. It has been status quo, it feels like a tetanus shot. She still has swelling in tongue, but they told her that might take a day or two to go away. She is supposed to also take Benadryl for the next 2 days. She was given the vaccine at the (Place name). Events visit to Emergency Room. They did a CBC and she was in normal range for everything. Lab data included on 20Jan2021: CBC normal. Outcome of the event Swollen tongue was recovering. Outcome of the event Anaphylactic reaction/anaphylaxis was recovered. Outcome of the event injection site soreness was not recovered. Outcome of the events was unknown.
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| 36 | 2021-02-07 | dizziness, throat pain, migraine, malaise, headache, chills, cough, fatigue |
She couldn't walk for 4 days; Migraine; Bone pain; skin hurt to the touch; Her skin even hurt to tou...
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She couldn't walk for 4 days; Migraine; Bone pain; skin hurt to the touch; Her skin even hurt to touch. She was sensitive all over.; Chest burning and hurting; Joint pain; extremely dizzy; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; arm was sore/soreness where they gave the vaccine on her arm all the sudden came back very suddenly; The lady that gave it was not gentle. She screamed.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EL1284) via an unspecified route of administration on 03Jan2021 at a single dose for covid-19 immunization. The patient had headaches in the past. The patient's concomitant medications were none. The patient got vaccine on the 03Jan2021 and her arm was sore, but she felt like this was normal, just like it would feel after a flu shot. Throughout the next week, she was extremely stressed for work. By Friday, which would have been 6 days later. She was feeling really off wellness wise. She was very fatigued, and extremely dizzy on 07Jan2021. On Saturday night 09Jan2021, she felt very bad. She had a sore throat, she was coughing, her chest was burning and hurting. She had severe chills and aches. She thought maybe she needed more sleep because she works out 6 days a week. She felt like she was in over drive like she was killing herself. Sunday morning 10Jan2021, she felt bad. She has so much adrenaline. She was always on the go. She decided to take a nap before the gym Sunday, and she woke up with a huge migraine. She had headaches in the past, but never a migraine. Her head was hurting so bad it woke her up. It hurt all over. She also felt like she had taken a hammer to her joints and bones. Her joints and bones were hurting. She has never felt that before. Her muscles were so achy. Her skin even hurt to touch. She was sensitive all over. She had severe chills. The soreness where they gave the vaccine on her arm all the sudden came back very suddenly. It came back the same day as the other symptoms started. They mostly started on the 09Jan2021, and then on the 10Jan2021 they were worse while migraine and bone hurting were occurred on 10Jan2021. She assumed there were subtle symptoms leading up to the 09Jan2021, but she just didn't realize it. That was a Saturday and Sunday. The lady that gave it was not gentle. She screamed. The side effects lasted at least 5 days after the 10Jan2021. On the 10Jan2021, she did not feel well so she got tested for COVID because her boss told her to. They tested her Flu, COVID, and strep. She only tested positive for COVID on 10Jan2021. She felt like she wouldn't be able to drive. She couldn't walk for 4 days. She felt most of the symptoms had gone away around 5 days after the 10th except fatigue, feeling dizzy, and headaches here and there. She also had a little coughing here and there. That started 09Jan2021 and was ongoing but improved. She got the vaccine because the doctor at her practice really encouraged her to get it done. She also thought if she ever wanted to travel that she might need it. She thought in the long run she might benefit from having the vaccine. She felt peer pressured honestly to get it because she was sketched out to get it at all. She wants to know the rate of people testing positive for COVID after getting the vaccine. The outcome of the events sore arm, chest burning, joint and bone pain, skin even hurt to touch and sensitive was recovered on 15Jan2021, the outcome of the events screamed and couldn't walk was unknown and the outcome of the other events was recovering.
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| 36 | 2021-02-09 | throat swelling, throat irritation |
Pfizer-BioNTech COVID-19 Vaccine Anaphylaxis reaction Background -I have had one other anaphylaxi...
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Pfizer-BioNTech COVID-19 Vaccine Anaphylaxis reaction Background -I have had one other anaphylaxis event in my history in reaction to horse dander many years ago. As such per the guidance I remained in the waiting room for 30 minutes. After 30 minutes I had a light rash on both forearms and near the injection site on my left upper arm. I felt fine otherwise. I went up to the nurse in the monitoring room and showed her the rash. She asked if I was having trouble breathing. At the time I was not. She said I could take Benadryl for the rash as long as I had no allergy to Benadryl. I started driving home. During my drive my throat started to feel itchy and irritated. It proceeded to get worse and when I looked at my throat in the mirror it was very red and starting to be visibly swollen. I drove to the nearest hospital and checked myself in to the emergency room.
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| 36 | 2021-02-10 | cough, chills, shortness of breath, fatigue, migraine, dizziness |
Mental foggyness/forgetful; Chills; Migraine; Dizziness; Fatigue; Loss of appetite; Food tasted salt...
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Mental foggyness/forgetful; Chills; Migraine; Dizziness; Fatigue; Loss of appetite; Food tasted salty/rotten; Diarrhea; Vomiting; intestinal discomfort; Cough with some shortness of breath (relieved with asthma inhaler); Cough with some shortness of breath (relieved with asthma inhaler); This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Solution for injection; lot number: EL3249, expiration date: unknown) via unspecified route of administration in the arm left on 22Jan2021 08:00 at single dose for COVID-19 immunisation. Medical history included asthma, multifocal myoclonus, IBS/lynch syndrome, hypothyroidism, Allergy: Dairy (milk allergy), allergies, alcohol allergy, Allergy: beef (meat allergy), and allergy: adhesives (dermatitis contact). Patient was taking unspecified concomitant medications. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: urgent care center (also reported as Doctor's office). The patient experienced mental foggyness/forgetful, chills, migraine, dizziness, fatigue, loss of appetite, food tasted salty/rotten, diarrhea, vomiting, intestinal discomfort, and cough with some shortness of breath (relieved with asthma inhaler); all on 23Jan2021 at 06:00. The events resulted to: Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken in response to all events (unspecified). Patient also had teleconference with doctor. Outcome of all events was recovering.
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| 36 | 2021-02-17 | fatigue |
Fainting like episodes; Blurred vision; Severe vertigo; Chest pain; Fatigue; This is a spontaneous r...
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Fainting like episodes; Blurred vision; Severe vertigo; Chest pain; Fatigue; This is a spontaneous report from a contactable other health professional reported for herself. A 36-year-old female patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EL8982, via an unspecified route of administration in right arm on 15Jan2021 12:00 at single dose for covid-19 immunisation. There were no relevant medical history or concomitant medications. The patient was not pregnant at the time of vaccination.The patient had no allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.On 21Jan2021, exactly "4 1/2 days" after vaccine the patient experienced fainting like episodes, blurred vision, severe vertigo, chest pain, fatigue. The patient has been out of work since the 20th and she still had blurred vision. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received. The patient was not recovered from the events. She has been to the ER, cardiologist for an echography, ultrasonography of thyroids, Magnetic resonance imaging (MRI) of her head, went to ENT dr and neurologist in 2021. All blood work in 2021 came back normal as well. The reporter considered the event as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. She had negative Nasal Swab Covid test post vaccination on 22Jan2021.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of fainting like episodes cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 36 | 2021-02-21 | lethargy |
15 hours after injection I experienced severe joint pain all over my body. This continued until 32 h...
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15 hours after injection I experienced severe joint pain all over my body. This continued until 32 hours post vaccine. Motrin and Tylenol helped but didn?t completely take all pain away. Injection arm was slightly sore. I was lethargic until 36 hours post vaccine. All symptoms subsided the next morning.
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| 36 | 2021-02-21 | chills, fatigue |
Body aches, chills, mild fever, extreme muscle soreness. Fatigued. Injection spot bruised with larg...
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Body aches, chills, mild fever, extreme muscle soreness. Fatigued. Injection spot bruised with large red, hard and very sensitive to touch circle around it about 1.5-2 inches wide that is hot to touch. Has been there now for almost 4 days with no signs of easing up yet.
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| 36 | 2021-02-21 | chills, weakness, fatigue, headache, fever |
Starting the night of vaccine - had a headache about 8PM in evening .I woke up feeling weird through...
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Starting the night of vaccine - had a headache about 8PM in evening .I woke up feeling weird throughout the morning: fatigue - didn't want to move at all but not moving wasn't comfortable; fever, chills, joint and muscle aches - mostly in my back (I couldn't get comfortable) - felt like I had been hit by semi truck. Very weak - if that was a 10th of what COVID felt like, I didn't want it! Those symptoms lasted about three to five days. By the5th day - I was mostly back to myself. I took Motrin - which helped slightly for headache.
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| 36 | 2021-02-21 | malaise |
woke up feeling unwell a few hours ago; wife felt sluggish during the walk; her heart was racing; ha...
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woke up feeling unwell a few hours ago; wife felt sluggish during the walk; her heart was racing; hands were shaking; she felt as if she was going to faint; This is a spontaneous report from a contactable consumer (patient's husband). A 36-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 05Feb2021 12:30 for Covid-19 immunisation, being a caregiver. The patient medical history and concomitant medications were not reported. The patient previously received flu vaccine for immunization and had side effects. On 06Feb2021 she woke up feeling unwell a few hours before reporting. Reporter and patient went for a 4 mile walk and she felt sluggish during the walk and her heart was racing, hands were shaking and she felt as if she was going to faint. When they arrived back home the reporter checked her heart rate and it was not that high and her symptoms were subsiding. The reporter would like to know if his wife should go to the ER. A few years before the patient had side effects from the flu vaccine so he was expecting her to have a reaction to the Pfizer COVID vaccine. The patient underwent lab tests and procedures which included heart rate: it was not that high on 06Feb2021. The outcome of events was recovering. The reporter assessed the events as not serious. Information on the lot/batch number has been requested.
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| 36 | 2021-02-22 | throat irritation, headache |
About 10 minutes after getting the shot I suddenly felt like I was having an anxiety attack. My hea...
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About 10 minutes after getting the shot I suddenly felt like I was having an anxiety attack. My heart was racing and a tingling adrenaline feeling started in my head and spread down through my body. My throat felt strange, but I could still breathe. It started to subside after a couple of minutes but didn?t resolve completely for another hour or so. I also had a headache almost immediately. In the days following the vaccine I had such sore muscles it was hard to get out of chair or go upstairs. That lasted 3 days. About one week after the shot I started noticing my brain felt glitchy. At night I have not slept well since about one week after the vaccination and I frequently awaken feeling confused, stressed, and disoriented. This is not normal for me. Additionally, about 3 weeks after the vaccine I had another mild panic attack. I have not been troubled by panic attacks before getting the vaccine. As of today I am starting to feel less glitchy in my thinking. I am still not sleeping soundly and waking often, sometimes accompanied with confusion.
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| 36 | 2021-02-22 | cold sweat, dizziness, sweating |
Approx 10 minutes after receiving the vaccine client started c/o feeling hot inside and outside of b...
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Approx 10 minutes after receiving the vaccine client started c/o feeling hot inside and outside of body, sweating on neck, and light headed, clamminess to hands. Vitals monitored. no medications given.
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| 36 | 2021-02-22 | headache, chills, fatigue | Chills, body aches, lymph node swelling, headache, severe fatigue, purple bruise, swallowing issue |
| 36 | 2021-02-22 | somnolence, fatigue |
Extreme brain fog and fatigue. Burst of energy and then need to sleep for hours. Missing work due to...
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Extreme brain fog and fatigue. Burst of energy and then need to sleep for hours. Missing work due to effects.
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| 36 | 2021-02-22 | fatigue, headache | Headache, Tired, Fatigue, Leg and arm shooting pain |
| 36 | 2021-02-22 | fatigue | Pain to left axilla with swelling, redness to inject site one week later, general fatigue x 1 week. |
| 36 | 2021-02-22 | chills |
Staff reports feeling nauseaus, vomitted, shivers and general body aches, had a hypertensive episode...
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Staff reports feeling nauseaus, vomitted, shivers and general body aches, had a hypertensive episode BP of 150/100 at around 7:30am, was offered to be sent to hospital ER, was discharged from the hospital the same day with no new recommendations. Staff sent to hospital ER for evaluation, no new recommendation made, no further symptom reported
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| 36 | 2021-02-23 | dizziness |
Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as ...
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Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as if I was going to pass out. I had muscle weakness in my arms and legs. I managed to pull over safely; Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as if I was going to pass out. I had muscle weakness in my arms and legs. I managed to pull over safely; Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as if I was going to pass out. I had muscle weakness in my arms and legs. I managed to pull over safely; Exactly two hours after injection, while driving, I felt light headed, dizzy, then tunnel vision as if I was going to pass out. I had muscle weakness in my arms and legs. I managed to pull over safely; I was nauseous and couldn't walk; I was nauseous and couldn't walk; Felt like immediate drop in blood pressure; This is a spontaneous report from a contactable consumer. A 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN5318, via an unspecified route of administration at left arm on 09Feb2021 10:00 at a single dose for COVID-19 immunisation. The patient had no medical history. The patient is not pregnant. There were no concomitant medications. On 09Feb2021, exactly two hours after injection, the patient felt lightheaded and dizzy while driving, then tunnel vision as if she was going to pass out. The had muscle weakness in my arms and legs. The patient managed to pull over safely. She was nauseous and couldn't walk. This lasted about 15 minutes and then she was better. The patient felt like immediate drop in blood pressure. No treatment was received. The outcome of the events was recovered on an unspecified date.
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| 36 | 2021-02-23 | dizziness, fatigue, weakness |
Hives that itched and burned on my head; Hives that itched and burned on my head; Hives that itched ...
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Hives that itched and burned on my head; Hives that itched and burned on my head; Hives that itched and burned on my head; Rash to my face; Body aches; weakness; fatigue and woozy feeling xs 4 days; fatigue and woozy feeling xs 4 days; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ1686) via an unspecified route of administration on the left arm on 20Jan2021 23:15 at a single dose for COVID-19 immunization. Medical history included Raynaud's, hypotension, known allergies: barley, oatmeal, pork, tomatoes. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient previously took doxycycline and experienced allergies. Benadryl prior to administration. On 20Jan2021 03:00 PM, the patient experienced hives that itched and burned on her head - still remain after 6 days but improved. Rash to her face, body aches, weakness, fatigue and woozy feeling for 4 days. Events treatment included diphenhydramine (BENADRYL). The facility where the vaccine was administered was in a nursing home/senior living facility. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID test post vaccination included Nasal Swab (Rapid and PCR) on 21Jan2021: negative. Outcome of the events was recovering.
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| 36 | 2021-02-23 | headache, malaise |
I'm currently 20 hours post administration of my 2nd dose and feel lousy; light nausea approx 2 hour...
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I'm currently 20 hours post administration of my 2nd dose and feel lousy; light nausea approx 2 hours after adminstration; dull headache and intense body aches approx 8 hours after administration; dull headache and intense body aches approx 8 hours after administration; This is a spontaneous report from a contactable other hcp. A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), intramuscular on the left arm at the age of 36 years, on 26Jan2021 12:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included anaphylactic reaction, drug hypersensitivity to penicillin, food allergy to pistachios. The patient's concomitant medications were not reported. The patient had the first dose on an unspecified date in Jan2021. On 26Jan2021, the patient experienced light nausea approx 2 hours after administration. Then developed a dull headache and intense body aches approx 8 hours after administration. The patient was currently 20 hours post administration of 2nd dose (27Jan2021) and feels lousy. There was no treatment received for the adverse events. The outcome of the event feel lousy was unknown while other events were recovered on an unspecified date in Jan2021.
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| 36 | 2021-02-23 | chills, migraine | woke during the night with chills, body aches, and migraines, hurts to walk |
| 36 | 2021-02-25 | migraine, discomfort |
1st dose: 24 hrs after administration, I developed a searing migraine that lasted for approx 15 hour...
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1st dose: 24 hrs after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explore; 1st dose: 24 hours after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explor; 1st dose: 24 hours after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explor; This is a spontaneous report from a contactable self-reporting other health professional. A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686), intramuscularly on an unspecified date in Jan2021 at 13:00 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included anaphylactic reactions to penicillin and pistachios. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was administered to the patient in a hospital. The patient reported that twenty-four hours after administration she developed a searing migraine that lasted for approximately fifteen hours. She stated that "no medications could touch the pain" and it felt like her brain and eyeballs were going to explode. The patient specified that she did not receive any treatment for the events. The clinical outcomes of migraine, sensation of pressure and eye discomfort were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 36 | 2021-02-28 | fatigue |
Burning right arm; fatigue; This is a spontaneous report from a contactable other healthcare profess...
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Burning right arm; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 11Jan2021 09:30 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. On 15Jan2021, the patient experienced burning right arm and fatigue. Treatment was received for the adverse events which included MRI, NCS, Blood work. The events resulted to a doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 36 | 2021-02-28 | headache, dizziness | Headache , Dizziness, unsteadiness, diploplia, blurry vision started 1 week after second dose |
| 36 | 2021-03-03 | throat swelling |
I initially had itchiness at injection site, then more of my arm. At 15 minutes I talked with the nu...
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I initially had itchiness at injection site, then more of my arm. At 15 minutes I talked with the nurse, she looked at and we talked for quite a bit what I should do but I was feeling just fine and left to go home and take benedryl. I had just left the hospital (25 mins post shot) and my throat and tongue started swell rapidly. I called 911 and the county rescue responded. My breathing was normal by then. My body has been itchy all over since then and my throat remains minor swollen. I did not get an epi shot since I was mostly okay and the EMTs were convinced I had a panic attack so I just went home.
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| 36 | 2021-03-07 | headache, malaise, chills |
Moderate head/headache; jaw clenching; chills; feeling unwell; This is a spontaneous report from a c...
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Moderate head/headache; jaw clenching; chills; feeling unwell; This is a spontaneous report from a contactable consumer who reported for herself. A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 15Feb2021 at 15:15 (at the age of 36-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included sub clinical hyperthyroidism and obesity, both from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (received within two weeks of vaccination) included celecoxib (CELEXA), bupropion hydrochloride (WELLBUTRIN), vitamin D NOS (VITAMIN D) and levothyroxine, all for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received penicillin and amoxicillin and experienced allergy. On 16Feb2021 at 14:00 the patient experienced moderate head/headache, jaw clenching, chills and feeling unwell. The clinical course was reported as follows: "Moderate head began 23 hours later. Then chills, feeling unwell, and my jaw clenched shut. I slept all day and night and finally took Tylenol and a prescribed Ativan for the headache and jaw clenching. It did not help. I put a heating pad on my shoulders, neck, and head for the past two hours and that helped. I would not have been able to finish work if I had to work today. It was terrible." The events were reported as non-serious and did not result in hospitalization. It was reported that treatment was not received for the events. The clinical outcomes of the events moderate head/headache, jaw clenching, chills and feeling unwell were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 36 | 2021-03-18 | headache, fatigue |
severe biopsy proven perniosis of bilateral hands; headaches; fatigue; left sided facial numbness; T...
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severe biopsy proven perniosis of bilateral hands; headaches; fatigue; left sided facial numbness; This is a spontaneous report from a contactable physician. A 36-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), intramuscular on left arm on 16Dec2020 at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient has no known allergies and was not pregnant. She was not diagnosed with COVID prior to vaccination and has no other vaccine in four weeks. The patient received her vaccine at a clinic. On 16Dec2020, the patient developed severe biopsy proven perniosis of bilateral hands, right after the vaccine which was still lasting. She also had headaches, fatigue for 2 weeks post vaccination (as reported) and left sided facial numbness for hours post vaccination. She had pain and swelling of the fingers which inhibits her from working as an nurse. She has been on disability leave from work. All lupus and other autoimmune work up have been negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/ department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with amlodipine, prednisone course, topical steroids and pentoxifylline. The patient underwent lab test and procedure which included nasal swab which was negative post vaccination on an unspecified date. The outcome of the events was not recovered. The events were assessed as serious causing disability or permanent damage. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the perniosis of bilateral hands and other reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 37 | 2020-12-31 | fever, fatigue, chills, malaise |
3 months postpartum and breastfeeding, had low grade fever to 99 within hours and fatigue/myalgias. ...
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3 months postpartum and breastfeeding, had low grade fever to 99 within hours and fatigue/myalgias. This increased to chills, a temp of 101f (baseline 97.8), and myalgias/fatigue so severe Going to the restroom felt like running a marathon (which I have done). I had to fully lay down and couldn?t carry my 15lb son. I also had marked breast tenderness greater on the side of the injection. My son seemed to have trouble staying latched (?due to tiredness from my direct warmth), and had increased fussiness. I have never had more than a mild local injection reaction w tenderness with any other vaccine
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| 37 | 2020-12-31 | dizziness |
TIA symptoms - difficulty speaking, reports leaning towards the left side and was dizzy for about 10...
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TIA symptoms - difficulty speaking, reports leaning towards the left side and was dizzy for about 10min.
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| 37 | 2020-12-31 | respiratory tract congestion, chills, throat irritation |
Tuesday 12/29 - Initially pruritis, erythema and unraised rash to L antecubital fossa. Wednesday 12/...
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Tuesday 12/29 - Initially pruritis, erythema and unraised rash to L antecubital fossa. Wednesday 12/30 - Woke up with post nasal drip, congestion, scratchy throat, nausea. Pruritis, erythema and non raised rash to bilateral antecubital areas. Had intermittent chills without fever. Had muscle aching. Thursday 12/31 - Started to have pruritis to abdomen, no rash noted. Continue to have pruritis, erythema, non raised rash to bilateral antecubital areas. Continue to have post nasal drip, congestion, scratchy throat (none worse than the day before). No chills, only muscle aching. Friday 1/1 - Same as 12/31 so far.
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| 37 | 2021-01-01 | fatigue, weakness | Overwhelming fatigue/weakness |
| 37 | 2021-01-01 | headache, dizziness | Patient developed site injection (left arm), then headache, body aches, joint pain, and dizziness |
| 37 | 2021-01-01 | fatigue, dizziness |
soreness in left arm (site of injection) vertigo on 1/1/2021 at 5:30pm (dizziness that prevented sta...
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soreness in left arm (site of injection) vertigo on 1/1/2021 at 5:30pm (dizziness that prevented standing, nausea, extreme fatigue). Pt has never experienced vertigo before. On 1/2/21 some mild dizziness remains though the pt can resume normal activity in the home.
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| 37 | 2021-01-02 | fever, chills, fatigue | Body aches, chills, exhaustion, fever, injection site itching, swelling and redness. |
| 37 | 2021-01-02 | chills, headache, fatigue | Nausea Joint pain Chills Muscle pain Headache Tiredness Injection site pain Vomiting |
| 37 | 2021-01-02 | chills | chills and face felt flushed |
| 37 | 2021-01-03 | throat irritation |
5 minutes after the injection - felt a wave of tingling over upper body and itchy in back of throat....
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5 minutes after the injection - felt a wave of tingling over upper body and itchy in back of throat. 10-15 minutes later, it happened again. Denies shortness of breath, some itchiness on tongue. Tongue was not swollen. Advised to take oral Benadryl. Total monitoring time = 40 minutes and was discharged/released home.
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| 37 | 2021-01-03 | chills, dizziness |
Allergic reaction: after 10-15 min, got hives on arms and face, felt dizzy, fast heart rate (116), r...
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Allergic reaction: after 10-15 min, got hives on arms and face, felt dizzy, fast heart rate (116), rigors. The urgent response team started iv fluid 1L, gave solumedrol (IV) and Benadryl (IM). Paramedics transferred me to ER (which was downstairs in hospital). After 1 hour the hives faded and gone by 2h. They kept me for observation for 5h. I did not have any difficulty breathing, did not receive Epi.
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| 37 | 2021-01-03 | dizziness |
Dizziness post vaccine, came back to clinic and ate snack bc she had not eaten that morning. BP 130/...
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Dizziness post vaccine, came back to clinic and ate snack bc she had not eaten that morning. BP 130/80, felt better with food. 2 similar episodes the following day, no further epidose after 48h.
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| 37 | 2021-01-03 | fever |
Febrile to 39.4 was unable to work s/t work exclusion algorithm for one shift. Myalgias consistent w...
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Febrile to 39.4 was unable to work s/t work exclusion algorithm for one shift. Myalgias consistent with fever, relived by 600mg Motrin and sleep.
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| 37 | 2021-01-03 | fever | Fever of 101.5 and Heart palpatations |
| 37 | 2021-01-03 | fatigue, headache |
Headache x 3 days (very uncommon for patient) with only minimal relief from naproxen and acetaminoph...
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Headache x 3 days (very uncommon for patient) with only minimal relief from naproxen and acetaminophen dosed multiple times Fatigue (slept more than normal)
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| 37 | 2021-01-03 | fever | My lymph nodes in back of my throat swollen and I had joint pain. Also had a fever of 102.9. |
| 37 | 2021-01-03 | fever, night sweats, chills |
severe fever; chills; severe night sweats; hives throughout my body; a rash on my face; This is a sp...
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severe fever; chills; severe night sweats; hives throughout my body; a rash on my face; This is a spontaneous report from a contactable nurse. This nurse reported for helf that the 37-year-old female patient received first dose of bnt162b2 (BNT162B2, product: COVID 19, brand: Pfizer), via an unspecified route of administration on Left Arm on 19Dec2020 10:30AM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Known Allergies to medications, food, or other products:Cocoa butter. Concomitant medications were unknown. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that "Starting seven hours after the vaccine, I experienced severe fever and chills. The next morning, despite multiple anti-pyretics, the fevers/chills were worse. Also I experienced severe night sweats, likely related to the fevers. Three days after the vaccine, I began to have hives throughout my body and a rash on my face. Responds to Benadryl, but eventually reappears." The event started from 19Dec2020 05:30 PM. Treatment was received for the adverse event included Anti-pyretics, anti-inflammatories, anti-histamine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility type vaccine was hospital. No other vaccine in four weeks. The patient recovered with lasting effects. No Covid prior vaccination. No Covid tested post: vaccination. The outcome of the event was recovered/resolved with sequel in Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The reported events severe fever and chills, severe night sweats, and hives and a rash on face were likely related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 37 | 2021-01-04 | fever |
DAY AFTER VACCINATION, DEVELOPED SLIGHT MUSCLE ACHES IN UPPER BACK AND LOW GRAD FEVER (99.6) FOR A F...
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DAY AFTER VACCINATION, DEVELOPED SLIGHT MUSCLE ACHES IN UPPER BACK AND LOW GRAD FEVER (99.6) FOR A FEW HOURS. RESOLVED BY 1/2/21
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| 37 | 2021-01-04 | migraine |
Have had headache/migraine 6-24 hours after vaccine; intermittent severe stomach cramping; nausea; s...
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Have had headache/migraine 6-24 hours after vaccine; intermittent severe stomach cramping; nausea; severe diarrhea; vomiting; This is a spontaneous report from a contactable nurse (patient). A 37-years-old female patient, non-pregnant, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, in hospital, via an unspecified route of administration on 23Dec2020 at 10:30, at 37-years of age, at single dose in right arm for COVID-19 immunization. Medical history included anxiety, depression and migraines, all from an unknown dates. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), topiramate (TOPAMAX), buspirone hydrochloride (BUSPAR), ibuprofen and levocabastine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache/migraine 6-24 hours after vaccine (onset reported also as 25Dec2020 at 12:00 - to be clarified) and, on 25Dec2020 at 12:00, also reported as 24-72 hours after vaccine, she experienced intermittent severe stomach cramping, nausea, severe diarrhea and vomiting. The patient didn't receive any treatment for the events. The outcome of the events was unknown at the time of the report. Information on the lot/batch number has been requested.
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| 37 | 2021-01-04 | headache |
Headache; nausea; arm pain at the injection site; This is a spontaneous report from a contactable nu...
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Headache; nausea; arm pain at the injection site; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ek5730), intramuscular at the left arm on 23Dec2020 14:30 at a single dose for COVID-19 immunization. Medical history included anxiety. The patient was not pregnant at the time of vaccination and had no known allergy. Concomitant medication included trazodone and fluoxetine hydrochloride (PROZAC). On 24Dec2020 6 am, the patient experienced headache and moderate nausea for about 48-32 hours with significant arm pain at the injection site. The patient was not hospitalized for the events and did not receive any treatment. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020.
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| 37 | 2021-01-04 | headache, fatigue |
Headache; soreness at injection site; nausea; fatigue; This is a spontaneous report from a contactab...
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Headache; soreness at injection site; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown since misplaced/discarded) via intramuscular on 26Dec2020 17:30 on left arm at a single dose for COVID-19 immunization. The patient medical history included anxiety and attention deficit hyperactivity disorder (ADHD). The patient allergy for reglan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included atomoxetine hydrochloride (STRATTERA) and sertraline hydrochloride (ZOLOFT). The patient experienced Headache, soreness at injection site, nausea, fatigue on 27Dec2020 08:00 AM. The patient received Excedrin as treatment for the events. The outcome of the events was recovering. Information on the Lot/Batch number has been requested.
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| 37 | 2021-01-04 | shortness of breath |
I got the Covid Vaccine and Wondering I have been having increasingly shortness of breath for last f...
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I got the Covid Vaccine and Wondering I have been having increasingly shortness of breath for last few days; gotten worse everyday its a little bit worse; This is a spontaneous report from a contactable nurse. This nurse reported for self that the 37-year-old female patient received first dose of bnt162b2 (BNT162B2, lot: EJ1685, Expiration Date: Mar2021), via Intramuscular on left deltoid on 20Dec2020 at single dose for covid-19 immunisation. Medical history was none. Concomitant medications included Multivitamins and escitalopram oxalate (LEXAPRO). Nurse stated, "I was wondering I got the Pfizer (Covid) Vaccine on 20th and I have been having increasingly shortness of breath for last few days and I am wondering if that's the typical side effect of that. It wasn't prescribed, it was something given out to all the healthcare providers. It was like the first dose. It was first dose. I got an Intramuscular shot in left shoulder. Because I wanted to not spread it (Covid). I am not sure if it is due to the product, I got "6" (not clarified) from another patient, that's why I am calling, I want to know if this is like the typical side effect of vaccination or should I go get tested. I haven't taken any treatment yet. It's gotten worse everyday its a little bit worse." The outcome of the events was not recovered.
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| 37 | 2021-01-04 | dizziness |
Patient became lightheaded, flushed, tachycardic, and developed hives. Patient was administered 25m...
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Patient became lightheaded, flushed, tachycardic, and developed hives. Patient was administered 25mg of diphenhydramine orally and observed. Patient quickly began feeling better, hives disappeared. The patient left with 2 other coworkers.
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| 37 | 2021-01-04 | dizziness |
Received first COVID vaccine. A few minutes after vaccine, arm felt abnormal, tingly, then 5 minutes...
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Received first COVID vaccine. A few minutes after vaccine, arm felt abnormal, tingly, then 5 minutes after that felt lightheaded and tachycardic. Rapid response called while patient laid flat, transported to the ED. In the ED, vital signs were stable and was able to ambulate without problems.
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| 37 | 2021-01-04 | nasal congestion, headache, fever |
headache, fever 101.9, head congestion, loss of taste & smell, tested for COVID-19 on 1/04/2021 and ...
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headache, fever 101.9, head congestion, loss of taste & smell, tested for COVID-19 on 1/04/2021 and it was negative
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| 37 | 2021-01-04 | fatigue |
severe sore arm in limb it was given; nausea; fatigue; This is a spontaneous report from a non-conta...
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severe sore arm in limb it was given; nausea; fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 37-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot number and expiry date were unknown), intramuscular in the right arm on 23Dec2020 10:15 at a single dose for COVID-19 immunization. The patient has no other medical history. The patient has no known allergies. The patient has no COVID prior vaccination, and COVID was not tested post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), escitalopram oxalate (LEXAPRO), and vitamin c (ascorbic acid). The patient has no other vaccine in the past four weeks. On 23Dec2020 01:00 PM, the patient experienced severe sore arm in limb it was given (by nighttime she was almost unable to use her right arm, improved by next morning), nausea, and fatigue. The outcome of the events was recovered in Dec2020. No treatment was received for the adverse events. The report was considered non-serious. No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
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| 37 | 2021-01-04 | nasal congestion |
tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; tested po...
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tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; sinus infection; tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; Her nose being stuffed; tension headache on the back of head; her deltoid was hurting for 24 hours; active infection after getting the first dose; This is a spontaneous report from a contactable pharmacist (patient). A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right deltoid on 18Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient had active infection after getting the first dose, consult if it was still recommended to get the second dose next week or she should be delaying getting the second dose. The patient got the COVID vaccine on the 18Dec2020. Then on the 24Dec2020 she tested positive for the COVID virus. She was due to get the second vaccine on 08Jan2021. She was asking should she still get the 2nd dose of the vaccine since came up positive. The patient was having a symptom, she lost her sense of smell of 22Dec2020. She lost her sense of smell on the evening on 22Dec2020, it still had not come back at all. She did have sense of taste on the tongue. She thought it was sinus infection, because her head didn't hurt and she was not stuffed anymore. She stated that after the vaccine, she had a tension headache on the back of head, and her deltoid was hurting for 24 hours. Her headache started the same day in the evening, went on till lunch time next day. Her nose being stuffed which she thought was a sinus infection started on Tuesday 22Dec2020, it was more located in the front middle of her forehead. Her nose being stuffed which she thought was a sinus infection started on Tuesday 22Dec2020, it was more located in the front middle of her forehead. She did not have her Card to provide Lot and Expiry, it was at work at the hospital. She was administered the vaccine on the right deltoid, since she didn't want to sleep on it. Prior to vaccine she has had no positive test for Covid. Caller stated that this was super unfortunately coincidental. She had had no antibody test. She had no reactions to vaccines in the past. Test: Respiratory Panel. Result: Negative on unknown date. The outcome of events drug ineffective, COVID-19 and sinus infection was not recovered. The outcome of event tension headache and muscle pain was recovered in Dec2020. The outcome of rest events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the reported events of LOE, COVID 19 and other events, based on temporal relationship. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
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| 37 | 2021-01-05 | dizziness |
8:00 am: tongue numbness and reported to observer 8:05 am: tongue swollen lips numb 8:10 am: registe...
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8:00 am: tongue numbness and reported to observer 8:05 am: tongue swollen lips numb 8:10 am: registering in ER tachycardia. Throat mouth dry and tight change to hoarse voice lightheaded. EpiPen administered. Ekg done. Other meds provided: 500 ml saline bolus. Famotidine, prednisone, benadryl Angioedemia and readmittance to ER approximately 18hrs later: prednisone,epipen, benadryl iv and po, famotidine, saline bolus
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| 37 | 2021-01-05 | headache, fatigue |
Arm soreness; headache; fatigue; myalgias; arthralgias; undetectable antibodies; This is a spontaneo...
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Arm soreness; headache; fatigue; myalgias; arthralgias; undetectable antibodies; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#EK9231) for the first dose via intramuscular in the left arm on 22Dec2020 12:00 for COVID-19 immunization. Medical history included post viral syndrome (COVID) or long COVID from Mar2020. The patient had undetectable antibodies in Apr2020. Concomitant medications included curcuma longa rhizome, piper nigrum fruit (TURMERIC +), colecalciferol (VITAMIN D), cobamamide (VITAMIN B12), bifidobacterium lactis (PROBIOTIC). The patient was diagnosed with COVID-19 prior to vaccination. The patient had no known allergies (NKA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not tested for COVID-19 since the vaccination. The patient had arm soreness 3 days, 1 headache, fatigue starting from night of injection increasing to requiring 1 hour nap on day 6 and 7, myalgias and arthralgias day 6 and 7; events onset date reported as 22Dec2020. Blood drawn 1 week after injection and the patient had undetectable antibodies in Dec2020, no movement in her CD4 or CD8 in T lymphocyte panel. The events resulted in doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovering.
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| 37 | 2021-01-05 | fever | Fever |
| 37 | 2021-01-05 | chills, fever | Fever 100, chills, body aches, joint pain |
| 37 | 2021-01-05 | headache, fever | Headache, Myalgia, felt warm-feverish Narrative: Taking OTC NyQuil every 4-6 hours. |
| 37 | 2021-01-05 | dizziness |
MINUTES AFTER VACCINE WAS ADMINISTERED PATIENT FELT DIZZY THEN COLD FLUSHING FEELING FROM FEET TO HE...
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MINUTES AFTER VACCINE WAS ADMINISTERED PATIENT FELT DIZZY THEN COLD FLUSHING FEELING FROM FEET TO HEART AND THEN THAT STOPPED AND TINGLING FEELING THROUGHOUT BODY AND THEN VERY WARM, AND FAINT FEELING. PATIENT DID NOT FAINT. PATIENT DID VOMIT ONCE. PATIENT HAD NOT EATEN BEFORE VACCINATION WAS ADMINISTERED. 1255 VITALS: BP: 126/91 P:100 SAO2 1303 VITALS: BP: 116/99 P: 96 SA02: 100% PATIENT STATES THEY ARE FEELING BETTER. GIVEN JUICE AND BANANA. 1312 VITALS: BP: 128/87 P: 74 SA02: 100% PATIENTS COLOR HAS RETURNED TO NORMAL. STATES THEY ARE FEELING MUCH BETTER. ABLE TO STAND AND WALK WITHOUT DIZZINESS. PATIENT STATED THAT THEY DID NOT FEEL THEY NEEDED ANY FURTHER TREATMENT OR CARE. PATIENT LEFT WITH HER WORKMATE.
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| 37 | 2021-01-05 | migraine, fever | Migraine headache, vomiting 2pm day of Overnight fever 101.5 |
| 37 | 2021-01-05 | fatigue, headache |
Parasthesias began in my lower extremities intermittently about 36 hours following administration. T...
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Parasthesias began in my lower extremities intermittently about 36 hours following administration. These spread to my upper extremities and became consistent. Occasionally will appear in lips and trunk. These are associated with sensation of numbness and some discomfort in my extremities. I'm also experiencing significant brain fog, difficulty concentrating, and fatigue. Headaches are occurring about every other day. Symptoms are present currently and have remained relatively consistent in severity. Was evaluated by urgent care on December 28 and encouraged to observe. Was evaluated in the ER by neurology on January 4. There leading hypothesis is vaccine related immune response. Neurologic exam was largely normal, being evaluated by a specialist in the coming days.
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| 37 | 2021-01-05 | chills | Queasy and cold chills |
| 37 | 2021-01-05 | nasopharyngitis, malaise |
Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, ...
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Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; cold; Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; feeling unwell that night, unable to sleep, tossing and turning all night; feeling unwell that night, unable to sleep, tossing and turning all night; This is a spontaneous report from a contactable nurse (patient herself). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration (left arm), on 29Dec2020 at 15:15, at a single dose, for COVID-19 immunization. Relevant medical history included food allergy (known allergies: raw bananas, avocados, melons, kiwi, tomatoes, oranges, grapes-make her mouth and lips itch). Concomitant medications were not reported. The patient previously received ibuprofen 400mg, a couple doses week prior. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. Patient is not pregnant at the time of vaccination. On 29Dec2020, at 21:00, patient experienced worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dreams. When she was able to sleep, she was still feeling unwell the next morning like she was recovering from a cold. The patient did not receive treatment for the events. Outcome of the events was recovering. Since the vaccination, patient has not been tested for COVID-19.
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| 37 | 2021-01-05 | shortness of breath, cough |
cough/wheezing cough; trouble taking a deep breath; This is a spontaneous report from a contactable ...
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cough/wheezing cough; trouble taking a deep breath; This is a spontaneous report from a contactable Other HCP (patient). A 37-year-old female patient received BNT162B2 via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunisation. Medical history included Known allergies: Penicillin. Concomitant medication included levothyroxine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and did not have COVID tested post vaccination. The patient started with slight cough approximate 5 minutes after injection. Cough increased to a wheezing cough with trouble taking a deep breath. Cough continued to get worse for approximate 45 minutes. The events started on 28Dec2020 16:00. No treatment for events. The outcome of events was recovered. Information on Lot/Batch has been requested.
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| 37 | 2021-01-05 | fever, chills |
developed a fever as high as 101.8; chills; This is a spontaneous report from a contactable pharmaci...
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developed a fever as high as 101.8; chills; This is a spontaneous report from a contactable pharmacist (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: EK9231), via intramuscular route of administration, on 23Dec2020 at 02:00 PM (at the age of 37 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Dec2020, at 03:00 PM, the patient developed a fever as high as 101.8 (no units provided) with no other symptoms beyond fever and chills. The patient did not take any anti-pyretics to treat the fever and her temperature came down on its own overnight. By the next day, she felt back to normal. No treatment was received for the events fever and chills. The outcome of the events fever and chills was recovered on 30Dec2020. Since the vaccination, the patient had been tested for COVID-19 (via saliva polymerase chain reaction [PCR]) with negative result.
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| 37 | 2021-01-05 | shortness of breath |
mild asthma attack; moderate dyspnea; chest pressure; a 4-5 cm area of induration; mild erythema in ...
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mild asthma attack; moderate dyspnea; chest pressure; a 4-5 cm area of induration; mild erythema in her left deltoid area; This is a spontaneous report from a contactable physician. A non-pregnant 37-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: Unknown), intramuscularly in the left arm on 19Dec2020 at 37-years-old at a SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included intermittent asthma from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced the following events and outcomes: mild asthma attack on 21Dec2020 with outcome of recovering, moderate dyspnea on 21Dec2020 with outcome of recovering, chest pressure on 21Dec2020 with outcome of recovering, a 4-5 cm area of induration in Dec2020 with outcome of unknown, mild erythema in her left deltoid area in Dec2020 with outcome of unknown. The patient had intermittent asthma with no attacks in the past six years. Two days after the vaccination, she had a mild asthma attack when she was walking up stairs. For the past two days, she has had multiple asthma attacks, with moderate dyspnea and chest pressure present for most of the day. The patient's symptoms have been improving with her as needed (PRN) salbutamol (ALBUTEROL) inhaler. The physician saw the patient in a telemedicine visit and found her to have an asthma exacerbation; therefore, prednisone was prescribed. The patient had no symptoms of viral infection and reported testing negative for COVID-19 after the onset of her asthma symptoms. The physician suspected her asthma exacerbation to have been caused by the vaccine because she had been symptom-free in recent years and she has not had a new exposure other than the vaccine. In addition to her respiratory symptoms, the patient had a 4-5 cm area of induration and mild erythema in her left deltoid area; this appeared about 1 week after she received the vaccine. Therapeutic measures were taken as a result of mild asthma attack, moderate dyspnea, chest pressure. The patient, since the vaccination, had been tested for COVID-19. Prior to the vaccination, the patient was not diagnosed with COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
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| 37 | 2021-01-06 | chills, fatigue, fever | 103 fever severe body aches chills and fatigue |
| 37 | 2021-01-06 | nerve pain |
Approximately 20 minutes after the first (and second) vaccine, I experienced numbness on my left sid...
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Approximately 20 minutes after the first (and second) vaccine, I experienced numbness on my left side. Both times I was vaccinated in my left arm. The first shot I experienced numbness to my left face, neck, ear and eventually my left arm and leg. I had no trouble with movement, the sensation felt dull. There was no associated pain. Numbness resolved completely after 2 days. The second shot, I again about 20 minutes following experienced numbness to my left face and ear. This time it resolved after a few hours. Also, two days following the first shot, I experienced severe nerve pain in my low neck/ upper back radiating down my right arm. As I do not remember injuring it, I am unsure if this is related to the vaccine or not. It has lessened in severity over time but is still present 3 weeks later.
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| 37 | 2021-01-06 | fever, headache, shortness of breath |
Fever, Severe headache and body aches, Tachycardia 120-150, Shortness of breath, Hypertension 160/11...
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Fever, Severe headache and body aches, Tachycardia 120-150, Shortness of breath, Hypertension 160/110
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| 37 | 2021-01-06 | dizziness, headache | HEADACHE, BODY ACHES, LEFT ARM SORE AT INJECTION SITE, DIZZINESS |
| 37 | 2021-01-06 | headache |
Headache neck pain/injection site soreness Narrative: injection site soreness lasted 24 hours; neck ...
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Headache neck pain/injection site soreness Narrative: injection site soreness lasted 24 hours; neck soreness for 36 hours; headache for several days
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| 37 | 2021-01-06 | fatigue, migraine, fever | Migraine-like headache, low grade temp, extreme exhaustion, congestion |
| 37 | 2021-01-06 | headache |
Moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ...
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Moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection; Moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection; This is a spontaneous report from a contactable physician (patient). A 37-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 17:15 at single dose on her left arm for covid-19 immunization. Medical history included known allergies to penicillin. The patient had no other medical history. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient was not received list of any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection on 23Dec2020. These events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient had received prednisone to treat the events. The outcome of the events was not recovered.; Sender's Comments: A possible contribution role of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of sensorineural hearing loss in left ear and headache cannot be excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 37 | 2021-01-06 | malaise |
Patient stated she had severe diarrhea and vomiting approximately 2 hours after she received the vac...
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Patient stated she had severe diarrhea and vomiting approximately 2 hours after she received the vaccine. She went to a walk-in clinic and they gave her benedryl 12.5mg and Zofran 4mg. She was not feeling better, and later went to the ER where she received 1000ml of Normal Saline, Tylenol 650mg and Zofran 4mg
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| 37 | 2021-01-06 | fever, fatigue, headache |
Pfizer BioNTech COVID 19 vaccine EUA- fever, headache, fatigue. Fever lasted less than 23 hours. n...
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Pfizer BioNTech COVID 19 vaccine EUA- fever, headache, fatigue. Fever lasted less than 23 hours. no medications still have slight HA
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| 37 | 2021-01-06 | dizziness |
Pfizer BioNTech COVID-19 Vaccine EUA; when patient was in 15 minute observation she reported feely d...
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Pfizer BioNTech COVID-19 Vaccine EUA; when patient was in 15 minute observation she reported feely dizzy and getting "tunnel vision." Patient sat down on the floor of her own accord without injury or difficulty. Had patient elevate her legs above heart level. Checked patients vitals, her blood pressure was low, but O2, respiration and pulse were within normal range. Patient was shaking and reported her tongue felt "tingly" and "heavy on my chest." Patient reported she had a smoothie prior to coming in for her appointment. She was given sprite. Patient felt better, but approximately 7 minutes later reported her stomach felt queezy. Blood pressure had improved and other vitals were still stable. Patient still reported her tongue felt "tingly," but no swelling, trouble breathing, or throat tightness. Patient was picked up by her father 45 minutes later and was able to ambulate to the car (with supervision) of her own accord without assistance.
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| 37 | 2021-01-06 | headache, sweating, chills |
chills, sweating, tachycardia , leg cramps, headache,back and neck ache evaluated in ED, EKG, IV flu...
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chills, sweating, tachycardia , leg cramps, headache,back and neck ache evaluated in ED, EKG, IV fluids, dehydration, elevated ketones 01/5/2021 03:30am 01/07/2021 Reported Feeling better, discomfort in lymph nodes under arm , Temp 99.. sweating, HR +80
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| 37 | 2021-01-07 | chills |
06 Jan 2021 @1336: Presented to ED about 15 minutes after vaccine with complaints of nausea, vomitin...
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06 Jan 2021 @1336: Presented to ED about 15 minutes after vaccine with complaints of nausea, vomiting, chills, and chest tightness. During this visit, she received IV fluids, Benadryl and Zofran by mouth.
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| 37 | 2021-01-07 | chills, dizziness |
16 Dec 2020 @1303: received dose at 0820, reports onset of chills and N/V sometime after 0900, >10 e...
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16 Dec 2020 @1303: received dose at 0820, reports onset of chills and N/V sometime after 0900, >10 episodes, intermittent lightheadedness. Also mid-sternal, non-radiating CP described as "burning and heaviness" that began approx. 6 min before ED arrival. Given 1L NS IV, GI cocktail PO, and Zofran, Benadryl, Solumedrol, and Pepcid IVP. Reported complete resolution of symptoms at 16 Dec 2020 @1529.
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| 37 | 2021-01-07 | fever, dizziness |
16 hours post shot, developed severe myalgias all over body, fever of 101, pain in my spine, back ne...
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16 hours post shot, developed severe myalgias all over body, fever of 101, pain in my spine, back neck, most of my muscles. Nausea. Lightheaded, dizzy. Left neck, chest and armpit lymphadenopathy.
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| 37 | 2021-01-07 | headache, fever, chills |
About 16 hours after injection (woke up the next morning) with myalgias, headache, chills, fever to ...
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About 16 hours after injection (woke up the next morning) with myalgias, headache, chills, fever to 100. Feeling flu like.
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| 37 | 2021-01-07 | weakness, sweating, fever, malaise, fatigue |
At 8:10 am Thursday started with a fever and swelling of my lymph nodes under my arm on the injectio...
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At 8:10 am Thursday started with a fever and swelling of my lymph nodes under my arm on the injection side, left, and just not felling well. By 2:30 pm on Thursday had high fever, muscle, bone and joint pain, weakness, chills and sweats. Pain in my swollen lymph nodes under arm. Fever broke Friday at 9 am still experiencing pain in lymph nodes, some sweating, generalized tiredness and over all just not feeling well.
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| 37 | 2021-01-07 | fever | Body aches and fever 100.4 |
| 37 | 2021-01-07 | chills, weakness, headache, night sweats, fatigue, dizziness | Chills, Dizziness, Night Sweats, Headache, Nausea, Body Aches, Weakness, Fatigue and Joint Pain |
| 37 | 2021-01-07 | headache, fever |
Comparable to COVID symptoms I had in October. Fever, headache, aches, painful"bee sting" type at i...
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Comparable to COVID symptoms I had in October. Fever, headache, aches, painful"bee sting" type at injection site.
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| 37 | 2021-01-07 | headache, fatigue |
EE reports that EE received 1st Covid-19 vaccine on 12/29/2020. EE report that later that evening EE...
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EE reports that EE received 1st Covid-19 vaccine on 12/29/2020. EE report that later that evening EE began experiencing the following signs and symptoms of injection site pain, joint pain, headache, fatigue, and muscle pain. EE reports that EE was extremely fatigued on 12/30/2020 that EE was not able to work. EE called in to work on 12/30/2020. EE reports that EE has RTW work today, but is still experiencing the symptoms, but with improvement.
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| 37 | 2021-01-07 | dizziness, headache, fatigue | Ears ringing, fatigue, diarrhea, headache and dizziness |
| 37 | 2021-01-07 | chills | FLUSH THEN CHILLS Narrative: |
| 37 | 2021-01-07 | fatigue, chills, nasal congestion |
Fatigue, sore left arm; Resolved. 12/29/2020 with pruritic rash to left forearm, chills, nasal conge...
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Fatigue, sore left arm; Resolved. 12/29/2020 with pruritic rash to left forearm, chills, nasal congestion, myalgias, then right forearm rash, itchy abdomen Benadryl/atarax without effect. COVID-19 test 12/28/2020 NEG result. Feeling slightly better today. COVID-19 test #2 scheduled for 01/04/2020.
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| 37 | 2021-01-07 | fever, headache, chills | Fever, chills, body aches, severe headache, nausea, vomiting |
| 37 | 2021-01-07 | night sweats, sweating | Night sweats, intermittent sweating for three days |
| 37 | 2021-01-07 | dizziness |
Reaction: Dizziness, heart palpitations (HR in the 120s), blurry vision Onset: 15 min post vax Treat...
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Reaction: Dizziness, heart palpitations (HR in the 120s), blurry vision Onset: 15 min post vax Treatment: Observation, fluids, food Summary: Sxs resolved after one hour of close monitoring Reported history of allergies: No, but pt had hx of new onset arrhythmia a few months prior
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| 37 | 2021-01-07 | dizziness, shortness of breath |
Season received the Pfizer-BioNTech COVID 19 vaccine today at 8:30 and scheduled for 30 minute wait ...
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Season received the Pfizer-BioNTech COVID 19 vaccine today at 8:30 and scheduled for 30 minute wait time because of prior history of anaphylaxis (non-vaccine). Within a few minutes she developed light-headedness and dizziness, these symptoms continued to worsen so she notified our nurse who was observing post-vaccine patients. She was promptly wheeled to our anaphylaxis room at 8:50 and placed in semi-Trendelenburg position. In addition to light-headedness and dizziness. she reported mild neck tightness and throat fullness. She had facial flushing and conjunctival injection with some tearing. She was monitored for Vital Signs and Oxygen Saturation. Within 20 minutes her symptoms progressed to chest heaviness, increased effort to take a breath and shortness of breath. She was mildly tachycardic with HR 96, though did not become hypotensive, B/P was 140/92. She had no gastrointestinal symptoms. She was anxious and "did not feel right", but did not report "impending doom". At 9:05 Epinephrine 1:1000, 0.3mL was administered IM, upper-outer thigh. Symptoms began improving within 8 to 10 minutes and were mostly gone by 9:20. At 9:17 she was given Diphenhydramine Solution 25mg, Famotidine 20mg, Prednisone 20mg. Her vital signs and Oxygen Saturation remained stable. (see flow sheet) Patient was monitored by an RN for 2 hours in our anaphylaxis room, on monitors, full crash cart present.
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| 37 | 2021-01-07 | chills, fever | Slight fever, 99.4, (ordinarily I run lower than normal), severe body aches, and chills. |
| 37 | 2021-01-07 | fatigue |
Sore arm for 72 hours Body aches, joint pain and fatigue starting at 27 hours post vaccination that ...
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Sore arm for 72 hours Body aches, joint pain and fatigue starting at 27 hours post vaccination that lasted 12 hours
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| 37 | 2021-01-07 | headache, sweating, fatigue |
Soreness and aching to left arm approximately 3hrs after vaccine. Nausea with dry heaves, body aches...
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Soreness and aching to left arm approximately 3hrs after vaccine. Nausea with dry heaves, body aches, sweats, extreme fatigue, and headache by 7:00 am the next day.
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| 37 | 2021-01-07 | headache, fatigue |
Sxs at injx site and fatigue. 12/22/2020 paraesthesias to upper/lower extremities, now becoming more...
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Sxs at injx site and fatigue. 12/22/2020 paraesthesias to upper/lower extremities, now becoming more consistent; headaches. Persistent sxs.
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| 37 | 2021-01-07 | fatigue, chills |
Symptoms - ? EE reports beginning at approximately 19:00 (1/7) chills and myalgias. EE reports she ...
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Symptoms - ? EE reports beginning at approximately 19:00 (1/7) chills and myalgias. EE reports she tossed and turned last night so woke up feeling pretty tired. EE reports today she feels okay minus feeling a bit tired. EE denies fever, COVID-19 exposure without proper PPE and recent travel. Last day of work and shift - ? unknown Home remedies? - none Any improvement? - yes Recommendation? EE encouraged to continue to monitor her symptoms and to call vaccine support line with further questions/concerns. EE verbalized back understanding and denied further questions at this time.
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| 37 | 2021-01-07 | dizziness, headache |
Tingling finger and toes, loss of sensation on injection arm, loss of motor function left arm and le...
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Tingling finger and toes, loss of sensation on injection arm, loss of motor function left arm and legs, numbness hands and feet, hands and feet became ice cold, headache, joint pain, muscle spasms, feeling drunk and dizzy, loss of consciousness 3x (reported by friend). confusion, inability to focus and complete thoughts and sentences. 911 called @12:04 PM by friend. At time of paramedics evaluation BP 175\100, O2 SAT 100%, loss of consciousness 2x(reported by friend) before being transported to University of Alabama at Birmingham (UAB) ER. No treatment except basic vitals taken, Held in waiting area for several hours then basic eval by ER doctor (unknown name) asked to attempt to stand, could not. Moved to ER room for couple hours, second eval by nurse to see of i could stand, had difficulty standing, asked to walk, shuffled feet to move and notified that i could go home
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| 37 | 2021-01-07 | fatigue, headache |
exactly one day later I felt was feeling severe fatigue, nausea, headache at the base of my head and...
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exactly one day later I felt was feeling severe fatigue, nausea, headache at the base of my head and diarrhea for 1.5 days; exactly one day later I felt was feeling severe fatigue, nausea, headache at the base of my head and diarrhea for 1.5 days; exactly one day later I felt was feeling severe fatigue, nausea, headache at the base of my head and diarrhea for 1.5 days; exactly one day later I felt was feeling severe fatigue, nausea, headache at the base of my head and diarrhea for 1.5 days; This is a spontaneous report from a contactable health care professional nurse, the patient. A 37-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 30Dec2020 13:00 as a single dose for COVID-19 vaccination. The patient had no known medical history or allergies. Concomitant medication included sertraline hcl (ZOLOFT). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested . Facility where the most recent COVID-19 vaccine was administered was at a Hospital. On 31Dec2020 13:00, the patient experienced exactly one day later I felt feeling severe fatigue, nausea, headache at the base of my head and diarrhea for 1.5 days. No treatment was given for the events. The clinical outcome of feeling severe fatigue, nausea, headache at the base of my head and diarrhea was recovered. Information regarding lot number has been requested.
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| 37 | 2021-01-07 | dizziness |
feeling of dizziness and becoming lightheaded at times; This is a spontaneous report from a contacta...
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feeling of dizziness and becoming lightheaded at times; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 28Dec2020 06:00 at single dose at left arm for covid-19 immunization. Medical history was none. No known allergies to medications, food, or other products. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient had been having a constant feeling of dizziness and becoming lightheaded at times, it varied in severity but it was constant on 31Dec2020 08:00 with outcome of not recovered. Patient didn't receive treatment for events. The adverse events result in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report is considered non-serious.
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| 37 | 2021-01-07 | headache, fatigue, shortness of breath |
headache/had a headache for 24 hours; both arms being shaky; short of breath/shortness of breath wig...
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headache/had a headache for 24 hours; both arms being shaky; short of breath/shortness of breath wigged her out/shortness of breath; sore in both arms/Both of her arms were sore; Her sats dropped to 92% on a pulse ox/oxygen saturation dropped; shortness of breath wigged her out; This is a spontaneous report from a contactable nurse reporting for herself. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunisation. The medical history included she had COVID back on 11Oct2020. The concomitant medications were not reported. The patient received the first dose of COVID-19 vaccine on 21Dec2020 and 2nd dose is due on Friday. She reported being sore in both arms and short of breath, stats 92% on pulse ox. The day after the vaccine, on 22Dec2020 she had the same symptoms as when she had COVID. Both of her arms were sore. She was short of breath. Her sats (saturation) dropped to 92% on a pulse ox (oximetry). The shortness of breath wigged her out. She stated she experienced shortness of breath and her oxygen saturation dropped for 48 hours. She was healthy before this with no preexisting conditions. She didn't know if she should get the second vaccine. She read most people are getting a bigger response from the second vaccine. She stated she also had a headache on an unspecified date. She had a headache for 24 hours and she experienced both arms being shaky on an unspecified date. The patient stated her symptoms were similar to when she had COVID and that she did not wait 90 days before getting the first dose of the COVID vaccine since she had COVID. She was scheduled to receive her second dose of COVID vaccine on 08Jan2021. She wanted to know if she was going to end up with a bigger reaction. The patient would like to know if she should receive the second dose since she had a reaction to the first dose. The events were reported as non-serious. The event outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 37 | 2021-01-07 | headache, malaise | nausea, headache, body aches, general malaise |
| 37 | 2021-01-07 | throat swelling | tongue swelling, throat swelling chest tightness, itching neck |
| 37 | 2021-01-08 | chills, fatigue | Aches, Chills, Nausea, vomiting, fatiuge - 48 hours. chest tightness- 6 hours |
| 37 | 2021-01-08 | headache, chills |
Approximately 10 hours after receiving the vaccine, I had a sore arm. Then experienced aches in my ...
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Approximately 10 hours after receiving the vaccine, I had a sore arm. Then experienced aches in my hip and knee joints, hot sweats alternating with chills, I did not take my temperature. I woke up the next morning with a headache and skin sensitivity. I took ibuprofen alternating with Tylenol and started to feel better. I felt back to normal about 36 hours after receiving the vaccine.
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| 37 | 2021-01-08 | fatigue, headache |
Day 1: shoulder pain, headache, fatigue, and temp of 99 Day 2: severe nausea, fatigue, headache, and...
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Day 1: shoulder pain, headache, fatigue, and temp of 99 Day 2: severe nausea, fatigue, headache, and body aches
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| 37 | 2021-01-08 | fatigue, headache | Headache fatigue, medication taste in throat, taste sensation off Narrative: |
| 37 | 2021-01-08 | headache | Headache, Myalgia & Arthralgia Narrative: |
| 37 | 2021-01-08 | fever, headache |
Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative: Employee reported adverse events l...
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Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative: Employee reported adverse events lasted for 2 to 2.5 days then resolved
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| 37 | 2021-01-08 | headache, fever | Headache, Myalgia, felt warm-feverish Narrative: Taking OTC NyQuil every 4-6 hours. |
| 37 | 2021-01-08 | headache, malaise, chills, fatigue | Headache, Myalgia, malaise/fatigue, chills without fever Narrative: |
| 37 | 2021-01-08 | fever, fatigue, headache |
onset of fever 30 minutes post-injection lasting approx. 1-2 hours. Three days later began w/headac...
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onset of fever 30 minutes post-injection lasting approx. 1-2 hours. Three days later began w/headache, fever, body aches, fatigue, nausea, diarrhea.
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| 37 | 2021-01-09 | shortness of breath, body temperature increased, chills |
1220p- received IM vaccine 1130p- woke up with shortness of breath, chills/rigors, and moderate bod...
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1220p- received IM vaccine 1130p- woke up with shortness of breath, chills/rigors, and moderate body aches. Afebrile at this time. Took Tylenol 1000mg PO and went back to sleep. 1/9/21- 945a- Body aches had been improving but progressively getting worse at this time. Tylenol 1000 mg PO taken again. Remained afebrile. 245p- Chills started again, body aches continued. Temp= 100.6. Tylenol 1000mg PO taken. 1/10/21- 630a woke up for the day and continued to have body aches. Temp = 100.9, took Tylenol 1000 mg PO. 730a- reported symptoms to work occupational health and told could return when afebrile without Tylenol and cleared by them. Will continue to monitor symptoms. 730p= Chills and body aches continued. Temp= 101.9. Took Tylenol 1000mg PO and went to bed for the day.
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| 37 | 2021-01-09 | chills, fever, sweating |
First vaccine received 12/18/2020. Diagnosed with COVID-19 12/28/20. Illness lasted 4 days. Returned...
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First vaccine received 12/18/2020. Diagnosed with COVID-19 12/28/20. Illness lasted 4 days. Returned to work 1/8/21. Second vaccine dose received 1/8/21 at 11:30am. Muscle aches, chills, and fever started at 19:30 on 1/8/21 and persisted throughout the night retning every 4 hours while alternating Tylenol 650mg every 4 hours and Ibuprofen 600 mg every 6 hours. Last fever was at 12:30pm on 1/9/21. Chills without fever at 4am on 1/10/21. Sweats and right arm localized redness and soreness persisted through 1/10/21 at the time of this report.
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| 37 | 2021-01-09 | nasal congestion, fever, chills, headache |
I developed body aches about 10-11 hours after the vaccine, then fever (100.4F degrees), chills, mi...
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I developed body aches about 10-11 hours after the vaccine, then fever (100.4F degrees), chills, mild nasal congestion, and mild headache, which lasted for 1-1.5 days.
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| 37 | 2021-01-09 | dizziness, shortness of breath |
I woke up this morning with swelling (angioedema) around my eyes. I took 50 mg of Benadryl and the s...
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I woke up this morning with swelling (angioedema) around my eyes. I took 50 mg of Benadryl and the swelling reduced, but isn't gone. About an hour after Benadryl I had some shortness of breath and dizziness that improved with sitting down. I have also had stomach cramping and diarrhea that began aroun noon. Diarrhea symptoms have improved with use of Imodium.
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| 37 | 2021-01-09 | sweating, fever, chills |
Previous COVID 19 infection 2 weeks prior to 2nd vaccine. 8 hours after 2nd vaccine, muscle aches, c...
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Previous COVID 19 infection 2 weeks prior to 2nd vaccine. 8 hours after 2nd vaccine, muscle aches, chills, fever started. All symptoms persisted throughout the first night. Muscle aches, chills, and fever returned every 4 hours with alternation of Tylenol 650mg every 4 hours and Ibuprofen 600mg every 6 hours. Last fever was at 12:30pm on 1/9/21. Some chills without fever noted at 4am 1/10/21. Sweats and right arm soreness with localized redness to injection site have continued into 1/10/21 to the time of this report.
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| 37 | 2021-01-09 | fatigue | Sore arm, upset stomach and fatigue. |
| 37 | 2021-01-10 | shortness of breath, weakness, chills, dizziness, headache |
1/9/21 Approximately 2:00 AM I was woken with Chills/joint pain/Injection Site Pain/Nausea had dizzi...
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1/9/21 Approximately 2:00 AM I was woken with Chills/joint pain/Injection Site Pain/Nausea had dizziness and weakness 1/9/21 Approximately 4:00 AM had headache/difficulty breathing/fast heartbeat along with the above 1/9/21Approximately 6:00 AM had a fever along with the above but the difficulty breathing and fast heartbeat had passed The remaining of Saturday Am I slept off and on with a terrible headache/difficulty catching my breath at times and taking IBP 2 times throughout the day/drinking plenty of fluids.
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| 37 | 2021-01-10 | fever, headache, fatigue | 100.4 fever Significant body aches Significant Fatigue Headache Joint Pain |
| 37 | 2021-01-10 | migraine, headache, dizziness |
2 week migraine; headache; flushed/Got flushed; persistent extreme dizziness; This is a spontaneous ...
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2 week migraine; headache; flushed/Got flushed; persistent extreme dizziness; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EK5730, Intramuscular at single dose on 17Dec2020 19:00 on right arm for precaution as front line health care worker. Medical history included Hemiplegic migraine. Her mother also had migraines. Concomitant medication included ranitidine hydrochloride (ZANTAC) and H1 and H2 blocker. The patient called to report AE of flushed, persistent extreme dizziness, and a headache that has evolved into a 2 week migraine. She has a history of hemiplegic migraines and was taking and h1 and h2 blocker when she received the vaccine. She was calling on guidance whether or not to receive the second vaccine. She was scheduled for second dose on Thursday, but wanted to speak with someone before she got it to see if it was OK. About 15 minutes after receiving the first dose, she got flushed and extremely dizzy. She had a mild headache when she woke up on 18Dec2020 06:00, which then developed into a severe migraine on 22Dec2020 08:00 that she has had for 2 weeks and dizziness continues. She received it at work and there was no prescriber. She called and left a message with Pfizer but has not heard back from anyone yet about this. She would say the flushed and dizziness would be medically serious because she had allergies and had medication on board. She takes daily allergy medication and Zantac and not sure she would not have had a worse reaction if she hadn't had that on board. She took it every night. She had an H1 and H2 blocker on board. Flushed has improved but the dizziness has stayed constant. She had been treated twice for headache and now they have put her on a Prednisone taper. She got it on her right arm so she could work her arm out. On 22Dec2020, she saw a Neurologist for the Migraine. They gave her Toradol 30 mg and Zofran 4mg injection in office. They were given IM. Then, she had another office visit for urgent care on 02Jan2021, and that was for the exacerbation of the migraine. They prescribed 1 liter of fluids and then another Toradol injection, Zofran injection and Decadron injection. The dose of the Toradol was 30 mg, Decadron was 6 mg, and Zofran was 4mg. These were given IV in urgent care. The patient had no prior vaccinations within 4 weeks. The outcome of flushed/Got flushed was resolving. The outcome of other events was not resolved.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events flushing, dizziness, headache and migraine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 37 | 2021-01-10 | fever, malaise, fatigue, shortness of breath, cough |
Approximately 15 minutes after receiving the vaccine, client started c/o itching to face and lips. T...
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Approximately 15 minutes after receiving the vaccine, client started c/o itching to face and lips. Transported to triage area. Where she started c/o burning lips also. vital signs monitored, Benadryl 50mg po given. In a few minutes she reported chest tightness, labored breathing. 1:44pm Epinephrine was given IM. client was on 02 increased to 15 Liters. She admits to decreased chest tightness and itching of face improving. She was taken by ambulance to hospital, where she was admitted overnight for observation. She was given Benadryl and epi X2 more time, once in ambulance and once at the hospital. She denies any problems since then. She did say that approx 3 weeks ago she was a contact to a case of covi
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| 37 | 2021-01-10 | fatigue |
Arm soreness throughout entire arm hours 2-24 post vaccine, peak about 12hr then relenting. Myalgia...
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Arm soreness throughout entire arm hours 2-24 post vaccine, peak about 12hr then relenting. Myalgias sporadic and brief, with fatigue, 36 hours post vaccine, resolution within 12 hours.
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| 37 | 2021-01-10 | fever | Brain fog, fever, aches lymph pain |
| 37 | 2021-01-10 | cough, nasal congestion |
COVID Vaccine #1 given to me in my left arm at 12:20pm -( I pre treated at 1140 am with 25 mg of Ben...
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COVID Vaccine #1 given to me in my left arm at 12:20pm -( I pre treated at 1140 am with 25 mg of Benadryl) At 2:25pm I began to feel a burning sensation in my chest (almost like heartburn) however I had not eaten anything. At 2:30pm I became very congested (nasal congestion and bilateral ear congestion) At 2:35pm I began coughing and could hear a wheezing sound when breathing in. -I took another 25 mg tablet of Benadryl At 2:45pm I took 20mg of Pepcid At 315 pm I went to sleep I woke up at 6:30 pm and my eyes were puffy , and my lip were enlarged and swollen. No pain or discomfort All other symptoms (chest burning sensation, coughing, congestion, wheezing) resolved. At 645pm I took 25mg of Benadryl Slept all night Woke up at 630am on 1/9/2021 and all symptoms including facial swelling, enlarged lips, chest burning sensation, coughing, congestion and wheezing had resolved.
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| 37 | 2021-01-10 | chills, headache, fever |
Chills and low grade temp of 99.9 Friday evening. Reports extreme dry mouth, headache, and body ach...
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Chills and low grade temp of 99.9 Friday evening. Reports extreme dry mouth, headache, and body aches. Motrin taken on Saturday and Sunday with improvement.
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| 37 | 2021-01-10 | fever, chills, headache |
Employee reports rash to torso running up to neck / chin, severe genralized body aches, fever, chill...
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Employee reports rash to torso running up to neck / chin, severe genralized body aches, fever, chills, headach. Was unable to function due to reaction for 24hours. Said all resolved. Did not seek treatment. Adivsed by Emp Health to not receive 2nd vaccine unless consults with MD for clearance.
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| 37 | 2021-01-10 | weakness, fever, malaise, headache, fatigue, chills |
For my first Pfizer shot I got fever of 102, chills, headache, muscle aches, malaise, weakness for 4...
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For my first Pfizer shot I got fever of 102, chills, headache, muscle aches, malaise, weakness for 4 hours about 16 hours after shot. Following this, the headache and fatigue remained the rest of the day. Periodic headaches noted in the weeks following. After my second Pfizer Covid shot I experienced nausea, diarrhea, extreme fatigue and exhaustion, malaise 4 days are shot lasting about 24 hours in duration.
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| 37 | 2021-01-10 | shortness of breath, fatigue, runny nose, respiratory tract congestion, fever |
Got sick on Christmas Day 25th- low grade fever/aches; diarrhea; went on to have shortness of breat...
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Got sick on Christmas Day 25th- low grade fever/aches; diarrhea; went on to have shortness of breath and some runny nose and congestion and a lot of fatigue 27th. Went to urgent care - was really tired; runny nose and congestion; Covid test was positive. Regenerome - On the 30th. Tylenol and Ibuprofen.
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| 37 | 2021-01-10 | dizziness |
Sudden onset dizzyness 5 minutes after immunization.HR Increased 130, decreased to 90 w rest. Transp...
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Sudden onset dizzyness 5 minutes after immunization.HR Increased 130, decreased to 90 w rest. Transported to medical Clinic for observation
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| 37 | 2021-01-10 | chills, runny nose, fever | arm soreness fever chills achiness runny nose |
| 37 | 2021-01-10 | headache | balls palsy headache arm sore |
| 37 | 2021-01-10 | headache | balls palsy headache sore arm |
| 37 | 2021-01-10 | fatigue, headache |
extreme fatigue with, headache. Went to ER And Received fluids And meds for headache. SEEN IN E.D 1/...
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extreme fatigue with, headache. Went to ER And Received fluids And meds for headache. SEEN IN E.D 1/7 & 12/19 (after both 1st & 2nd vaccine) ZOFRAN & FLUIDS IN E.D. DIAGNOSIS "NEAR SYNCOPE"
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| 37 | 2021-01-10 | headache, chills | headache, chills, joint pain, nausea, swollen lymph nodes in right axillar area, |
| 37 | 2021-01-11 | cold sweat, fever, dizziness, chills |
1/8fever, chills, cold sweat, body aches, pain, 1/9 dizziness, vomiting bile, Hives on chest and b...
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1/8fever, chills, cold sweat, body aches, pain, 1/9 dizziness, vomiting bile, Hives on chest and belly twitching lips and slurred speech,
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| 37 | 2021-01-11 | chills |
16 hours post vaccine, I awoke to chills/feeling of fever. I suddenly felt nauseous. I went and sat ...
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16 hours post vaccine, I awoke to chills/feeling of fever. I suddenly felt nauseous. I went and sat on the floor of my bathroom and went unresponsive. Per my husband. My eyes rolled back in my head, my body went limp, and I was moaning. I did not come to for 30-60 seconds despite shaking, calling my name, and sticking his finger in my throat. I came to and was alert and oriented but have no recollection of the incident. EMS was called.
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| 37 | 2021-01-11 | fatigue, chills, throat pain, headache | 2 days after: headache, body chills, sore throat, and fatigue. Third day: fatigue and body aches |
| 37 | 2021-01-11 | fatigue, headache |
Developed fatigue, lower back pain, facial puffiness and headache. Did not report to work the day ...
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Developed fatigue, lower back pain, facial puffiness and headache. Did not report to work the day after the vaccine. Symptoms resolved
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| 37 | 2021-01-11 | dizziness, throat irritation, migraine, headache | Dizziness/nausea, migraine headache, loss of appetite, itchy throat, ear pain |
| 37 | 2021-01-11 | chills, malaise, dizziness |
Dizziness; palpitations; resting tachycardia that persisted for 3 days; muscles aches; Chills; Restl...
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Dizziness; palpitations; resting tachycardia that persisted for 3 days; muscles aches; Chills; Restlessness; feeling unwell; arm pain; This is a spontaneous report from a contactable physician reported for herself. This 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) via intramuscular on 23Dec2020 09:30 AM on left arm at single dose for COVID-19 immunisation. Medical history included chronic kidney disease, HTN (hypertension), persistent proteinuria. No known allergies. Concomitant medication included losartan. The patient did not have other vaccine in four weeks and did not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 24Dec2020, the patient experienced dizziness, palpitations, resting tachycardia that persisted for 3 days, muscles aches, chills, restlessness, feeling unwell and arm pain, and resulted in Emergency room/department or urgent care. Treatment included paracetamol (TYLENOL). The patient had COVID tested on 28Dec2020 post vaccination, covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test result=Negative. Outcome of events was recovered.; Sender's Comments: The reported events dizziness, palpitations, resting tachycardia that persisted for 3 days, muscles aches, chills, restlessness, feeling unwell and arm pain, were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 37 | 2021-01-11 | headache | Facial numbness and headache Have had of history of Bell?s palsy he |
| 37 | 2021-01-11 | fever, chills, fatigue |
Fever up to 102; body aches; hip and back joint pain; chills; fatigue; This is a spontaneous report ...
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Fever up to 102; body aches; hip and back joint pain; chills; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (lot number: EH9899) on 18Dec2020 17:00 (first dose) then (lot number: EC1284) on 05Jan2021 07:45 (second dose); both intramuscular on the left arm at a single dose for COVID-19 immunization. The patient's medical history included anxiety and depression. The patient was not pregnant at the time of vaccination. Concomitant medication included citalopram and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin and experienced allergies to amoxicillin. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 05Jan2021 17:30, the patient experienced fever up to 102, body aches, hip and back joint pain, chills, and fatigue. Outcome of the events was recovering. The events were considered non-serious by the reporter.
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| 37 | 2021-01-11 | shortness of breath | Focused breathing, periodic SOB, tingling in the mouth |
| 37 | 2021-01-11 | headache, fatigue, cough |
I have a headache. My body is feeling fatigue, aching, and very soar. My arms are very heavy , soar...
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I have a headache. My body is feeling fatigue, aching, and very soar. My arms are very heavy , soar all the way down to my hands. A Slight cough has even occurred since the vaccine.
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| 37 | 2021-01-11 | chills, fatigue, headache, cough |
I started getting a mild headache as soon as I got home last night after I got vaccinated. I rested,...
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I started getting a mild headache as soon as I got home last night after I got vaccinated. I rested, but this morning im still having headache. My body feels aching , chills and very fatigue, slightly soar. A mild mild cough has even occurred. Including Soar Arms all the way down to my hands.
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| 37 | 2021-01-11 | headache |
I woke up the day after receiving the vaccine with full body aches and severe joint pain, especially...
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I woke up the day after receiving the vaccine with full body aches and severe joint pain, especially in the hips making it difficult to walk comfortably. I also had a moderate to severe headache. I was unable to work that day. The pain lessened with ibuprofen but returned later in the day. By the next day, symptoms were a lot better and after 2 days the symptoms completely resolved
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| 37 | 2021-01-11 | shortness of breath |
Localized itching at the injection site that progressed up arm and neck causing the patient to becom...
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Localized itching at the injection site that progressed up arm and neck causing the patient to become slightly short of breath and concerned for her safety
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| 37 | 2021-01-11 | cough, nasal congestion |
Lost complete sense of smell - Lasted 15 hr; smell and taste muted after they came back. 30 -36 hour...
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Lost complete sense of smell - Lasted 15 hr; smell and taste muted after they came back. 30 -36 hours after vaccine - Really bad nasal congestion - bad cough and those lasted 4 days. Urgent Care. Tested for COVID -Sunday, 27th, afternoon. Tested negative for Covid. Still do have muted taste and smell but don't have cough anymore.
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| 37 | 2021-01-11 | cough, nasal congestion |
Lost complete sense of smell - Lasted 15 hr; smell and taste muted after they came back. 30 -36 hour...
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Lost complete sense of smell - Lasted 15 hr; smell and taste muted after they came back. 30 -36 hours after vaccine - Really bad nasal congestion - bad cough and those lasted 4 days. Urgent Care. Tested for COVID -Sunday, 27th, afternoon. Tested negative for Covid. Still do have muted taste and smell but don't have cough anymore.
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| 37 | 2021-01-11 | weakness, chills, fatigue, headache, fever |
Pfizer-BioNTech COVID-19 Vaccine EUA 8hrs-40hrs after injection: fever (ranging from 102-104) chill...
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Pfizer-BioNTech COVID-19 Vaccine EUA 8hrs-40hrs after injection: fever (ranging from 102-104) chills, body aches, fatigue/weakness, loss of appetite, headache, vision changes, swollen right axillary lymph node (hard, painful) 40hrs-60hrs after injection: fever steady around 101, headache, fatigue, swollen right axillary lymph node (no longer hard, more disperse, still painful) 60+ hrs after injection: swollen right axillary lymph node (disperse, painful, bruising/discoloration) emailed ob/gyn about concern for swollen lymph node turning into mastitis, but referred to PCP
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| 37 | 2021-01-11 | chills, fever, headache, fatigue | Sore arm fever chills body aches headaches fatigue |
| 37 | 2021-01-11 | fever, headache | Sore left arm accompanied with a red bump the size of a quarter, mild headache, and fever of 100.8. |
| 37 | 2021-01-11 | malaise, fatigue, headache |
The morning after the 2nd dose of the COVID vaccine, I woke up with the above symptoms. They are imp...
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The morning after the 2nd dose of the COVID vaccine, I woke up with the above symptoms. They are improving with IBProfen and the symptoms did not prevent me from going to work. Fatigue, Headache, injection site pain, malaise and new or worsened muscle pain.
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| 37 | 2021-01-11 | nasopharyngitis |
The patient informed me right after she got the vaccine that she felt cold and tingly like after ane...
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The patient informed me right after she got the vaccine that she felt cold and tingly like after anesthesia. She also reported a metallic taste in her mouth. She was given water and observed for 30 minutes. I called and left a message for her on 1-12 to see how she was doing.
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| 37 | 2021-01-11 | headache, fatigue |
This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; N...
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This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; Numbness and tinging began in my lower extremities about 36 hours following injection. It started as intermittent and became more consistent and spread to my upper extremities. It is sometimes present; ng began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; discomfort in her extremities; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) via an unspecified route of administration (right arm), on 21Dec2020 at 10:45 at a single dose, for COVID-19 immunization. Medical history included migraine and latex allergy. The patient's concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. On 23Dec2020, about 36 hours following injection, numbness and tingling began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips. She was also experiencing some discomfort in her extremities. These were accompanied by headaches and significant brain fog, difficulty concentration, and fatigue. She was working on being evaluated by allergy and neurology. The patient did not receive treatment for the events. Outcome of the events was not recovered.
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| 37 | 2021-01-11 | throat pain |
Throat became very sore and staff member left work abruptly and went to an urgent care clinic. She h...
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Throat became very sore and staff member left work abruptly and went to an urgent care clinic. She had a negative strep test and a negative covid test. She also complained her right eye was twitching. Symptoms subsided in approx. 48 hours.
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| 37 | 2021-01-11 | dizziness |
Vaccine given about 09:20, patient ambulated 30 feet without difficulty, began texting on phone and ...
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Vaccine given about 09:20, patient ambulated 30 feet without difficulty, began texting on phone and shared her right arm & finger was numb & tingling. Patient became anxious acting, claimed "I feel dizzy & heart racing." Patient monitored, 09:25 heart rate less than 100, states dizziness has resolved, patients respirations even & unlabored skin pink and dry. 09:30 Patient talking in a relaxed manner with co-workers, does continue to complain of "my fingers feel asleep". Pt monitored for over one hour. Patient ambulating without issues out of observation area, skin pink warm, dry, no acute distress reports numbness & tingling resolved, has full range of motion to right arm.
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| 37 | 2021-01-11 | chills, fatigue |
body aches 7-8 hours later, worse body aches, chills and rigors 14 hours later for which 600mg motri...
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body aches 7-8 hours later, worse body aches, chills and rigors 14 hours later for which 600mg motrin taken, chills and rigors improved one later, body aches continued until 22 hours after vaccination where 600mg motrin taken again, minor body aches and fatigue until 36 hours after vaccination
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| 37 | 2021-01-11 | malaise, headache, dizziness, fever |
body aches; pounding head; low-grade fever; doesn't feel fine; "horrible" muscle aches particularly ...
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body aches; pounding head; low-grade fever; doesn't feel fine; "horrible" muscle aches particularly around the low hip area but also "all over"; feeling dizzy; elevated BP 155/100; This is a spontaneous report from a contactable consumer for self. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), Intramuscular in Right upper arm on 04Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included seasonal asthma as a kid and as she got older, it got worse. There were no concomitant medications. She reports the following AE's: "horrible" muscle aches particularly around the low hip area but also "all over", feeling dizzy, elevated BP 155/100 in Jan2021, "pounding head", low-grade fever, body aches 05Jan2021. She received the first COVID vaccine on 16Dec2020 and then the second vaccine yesterday. Now, she doesn't feel fine. The caller clarifies further with the first vaccine, she was fine. She had a sore arm and that's it. With this second vaccine, she doesn't feel fine. She didn't start feeling bad until around 1 a.m. She received the second vaccine yesterday, 04Jan2021. Around 1 a.m., she started feeling not so hot. She confirms she started to experience body aches, making the comment " it's ridiculous, it's my entire body". Also, a headache and low-grade fever. She states these symptoms didn't get really bad or worse until 10 this morning. Outcome of event feeling unwell was recovered on 05Jan2021, of headache, low-grade fever, body aches, was not recovered, of others was unknown.
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| 37 | 2021-01-11 | fatigue |
chest tightness; palpitations; elevated heart rate; fatigue; This is a spontaneous report from a con...
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chest tightness; palpitations; elevated heart rate; fatigue; This is a spontaneous report from a contactable Other HCP. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. Medical history included Dermatographia. The patient is allergic to Penicillin, lactose, Cephalosporins and Beepen-VK. There were no concomitant medications. Seventy two hours after the vaccine was given the patient had an elevated heart rate, chest tightness and fatigue. Are this consistent with the vaccine. She does not have a history of elevated heart rate or palpitations. She checked her heart rate with her Apple watch and sent in a strip to the doctor. The doctor is concerned and is asking if this is related. She went to the ER to make sure she was ok but was not admitted. Outcome of event heart rate increased as recovered on 05Jan2021, of fatigue was not recovered, of others was recovering. Information about Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of elevated heart rate, chest tightness, palpitations and fatigue due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including 12-lead EKG , counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 37 | 2021-01-11 | chills, fatigue | chills, fatigue, brain fog |
| 37 | 2021-01-11 | fatigue, fever, chills, sweating, headache |
extreme joint pain, fever and chills, muscle aching, severe head ache (lasting 3 days), excessive fu...
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extreme joint pain, fever and chills, muscle aching, severe head ache (lasting 3 days), excessive full body sweating x3 days, extreme fatigue (sleeping >16 hrs per day x3 days, 1 short bout of nausea, sensitivity to skin on back and legs i.e. a cotton shirt against my skin felt like it was burning me. loss of appetite. multiple doses of OCT analgesics/fever reducers. loss of scheduled work x2 days.
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| 37 | 2021-01-11 | fever | fever, rash, lymphadenopathy |
| 37 | 2021-01-11 | chills, fever, headache | low grade fever, chills, aches and pains, headache for 18 hours |
| 37 | 2021-01-11 | fever, headache, fatigue, shortness of breath, chills |
rash initially has resolved, fever 100.1F, chills,headache, heart rate 120, fatigue SOB states sympt...
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rash initially has resolved, fever 100.1F, chills,headache, heart rate 120, fatigue SOB states symptoms occur in afternoon advised to see PCP
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| 37 | 2021-01-12 | chills, malaise, headache, fatigue, fever |
1/12/21: Fever (100.3), chills 12:00 AM to 4:00 AM and fever (99.9), chills, mild headache 10:00 AM...
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1/12/21: Fever (100.3), chills 12:00 AM to 4:00 AM and fever (99.9), chills, mild headache 10:00 AM to 1:00 PM Malaise/fatigue all day on 1/12/21 Ibuprofen 400mg taken twice.
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| 37 | 2021-01-12 | headache, fever | 12 hours of headache, body aches, and low grade fever (99.5 - oral) |
| 37 | 2021-01-12 | fever, chills | Body aches, chills, fever of 99.7 lasting a couple of days |
| 37 | 2021-01-12 | headache |
Day after my second vaccine I had body aches, muscle and joint aches, neck stiffness, headaches and ...
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Day after my second vaccine I had body aches, muscle and joint aches, neck stiffness, headaches and was nauseated. I hurt so bad that I did not want to move. I Routinely took Ibeprofen every 6 hours and phenergran to help with my symptoms. These symptoms only last one day. Which was the day after my second vaccine.
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| 37 | 2021-01-12 | headache |
Experienced general aches, headache, soreness and irritation at the injection site as well as muscle...
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Experienced general aches, headache, soreness and irritation at the injection site as well as muscle pain in the shoulders and back. Symptoms began around 2000 on 01/09 and subsided overnight between 01/10 and 01/11.
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| 37 | 2021-01-12 | fatigue, malaise |
Fatigue, arm soreness, body aches, malaise, back pain, abdominal pain (all symptoms mild and resolve...
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Fatigue, arm soreness, body aches, malaise, back pain, abdominal pain (all symptoms mild and resolved in 1 day)
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| 37 | 2021-01-12 | fatigue, headache, throat pain | Fatigue, hot and cold flashes, headache, sore throat, mild joint pain, Nausea |
| 37 | 2021-01-12 | throat pain, fever, headache, respiratory tract congestion, chills, shortness of breath, fatigue, lethargy, malaise |
Following vaccination, I had a headache for few days along with some pain on injection arm. The hea...
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Following vaccination, I had a headache for few days along with some pain on injection arm. The headache continued and soon some fatigue and tiredness accompanied it for 7-10 days following vaccination. Then ten days after, I had an increase in symtpoms that included heightened fatigue, loss of appetite, feeling "cold"/ "hot" (no fever), and abdominal pain with nausea and some diarrhea. Two weeks after vaccination, I had an increased of fatigue and not feeling well, accompained by a fever of (101.5 F) and chills, sore throat, and lethargy. My symptoms of fever, chills, sore throat, body aches, congestion, and fatigue remained over the next few days and soon included chest pain and some increase work of breath. With two negative Covid tests through work, it was recommended I go to see a physician, who instead sent me to Immediate Care. There I had an EKG which showed sinus bradycardia and they sent me to ER due to my symptoms of chest pain and shortness of breath. At the ER, multiple tests were run to negative results. ER Physician suspects that some of my struggles could be related to Covid vaccine but that I also may have caught an non-Covid virus on top of it which led to acute bronchitis.
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| 37 | 2021-01-12 | headache |
Headache for 3 days - not attributable to other cause, don't usually get headaches. Treated with tyl...
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Headache for 3 days - not attributable to other cause, don't usually get headaches. Treated with tylenol, rest and hydration. Had to take the day off related to headache on day 3, then improved.
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| 37 | 2021-01-12 | fever, headache, chills | Headache, muscle ache, low grade fever, chills, loss of appetite |
| 37 | 2021-01-12 | fatigue, dizziness |
Immediately after IM injection of the vaccine, patient start with an ascending muscular pain through...
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Immediately after IM injection of the vaccine, patient start with an ascending muscular pain through shoulder and neck (left side). Didn't take any analgesic and went to sleep that night as usual. When she woke up next day felt dizzy and fainted. Husband held her and give alcohol to smell, what caused patient to respond. Took her BP and found it low (100/60). The person lay down and rested for an additional 2 hours and then continues her day as usual.
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| 37 | 2021-01-12 | shortness of breath, headache, fatigue |
Initially shot on 24th. Extremely benign - for 24 and 25th - dull headache and arm at injection sit...
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Initially shot on 24th. Extremely benign - for 24 and 25th - dull headache and arm at injection site was sore. 27th - all of a sudden I had an elevated resting heartrate - 140 - would go up and down and when it was down it didn't go to normal - it went to 90s and my resting heart rate is in 60s. And also had chest tightness, shortness of breath and fatigue. Went to ER That all lasted for 10 days. Fatigue aspect got better; the heartrate slowly started getting a little better. Chest tightness and shortness of breath - even when heartrate went down a little, I was still experiencing those symptoms anyway. Off and on thing for 10 days. Last 10 days - have significant improvement. Due for 2nd dose tomorrow - dr has advised I hold off.
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| 37 | 2021-01-12 | throat irritation |
Itchy throat making it more difficult to swallow. Nausea. Given Benadryl 50mg orally by NP. Vitals c...
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Itchy throat making it more difficult to swallow. Nausea. Given Benadryl 50mg orally by NP. Vitals checked and monitored for an additional hour.
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| 37 | 2021-01-12 | headache, fatigue, fever, chills |
Monday night started with Nausea and diarrhea Tuesday: chills, nausea, diarrhea, fatigue, headache ...
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Monday night started with Nausea and diarrhea Tuesday: chills, nausea, diarrhea, fatigue, headache Wed: chills, max fever 100.8, headache, fatigue, diarrhea
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| 37 | 2021-01-12 | shortness of breath, chills, cold sweat, fever |
Pfizer-BioNTech COVID-19 Vaccine EUA Patient is a 37 year old female who presents with dyspnea and m...
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Pfizer-BioNTech COVID-19 Vaccine EUA Patient is a 37 year old female who presents with dyspnea and myalgias following her second COVID vaccination today. Patient denies any history of vaccine associated reactions. After her first dose of the COVID vaccine she had fever, chills and myalgias as well as some sensory changes to the left arm. These symptoms lasted for around a day before resolving. Today, she received the second dose of the vaccine around noon and then began having dyspnea and chest pain around an hour later. Chest pain is moderately severe and worse with deep inspiration. Patient also having back aches and feeling clammy. Patient re-presented to the vaccine site and was brought to the emergency department for evaluation. Patient received acetaminophen 1000mg orally, ketorolac 15mg IV, and lactated ringers 1000ml IV and was discharged.
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| 37 | 2021-01-12 | dizziness, headache, throat pain, nasal congestion, fatigue |
Roughly 12 to 16 hours after receiving the vaccine I stated with some fatigue and body aches. I took...
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Roughly 12 to 16 hours after receiving the vaccine I stated with some fatigue and body aches. I took tylenol and motrin twice during the 12 hour shift at the scheduled times. I was working night shift when this happen and came home and went to bed 24 hours after receiving the vaccine. The time I went to bed had fatigue, headache, body aches with neck and back pain. Took tylenol and motrin before going to sleep. When I woke up at 4pm, 31 hours after receiving the vaccine I had, sore throat, head congestion, severe body aches and headache. I attempted to get up since I was scheduled to work at 7pm and then got dizzy. I took tylenol and motrin, put a heating pad on my back, drank some hot tea and went back to bed for the night. Woke up at 7:30am almost 2 days after receiving the vaccine still with headache, body aches and fatigue. The sore throat and head congestion seem to have subsided. Took more tylenol and motrin and went back to bed. Still at this time feel just tired and body aches, mostly in the neck and back.
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| 37 | 2021-01-12 | malaise, chills, headache, skin warm, fever, discomfort, fatigue |
about 12 Hours after vaccine - developed severe chills, headache, fever (102 F - with ibuprofen & ac...
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about 12 Hours after vaccine - developed severe chills, headache, fever (102 F - with ibuprofen & acetaminophen), severe muscle aches, could barely move or sleep About 24 Hours after vaccine - same symptoms continued but developed very painful golf ball size lump under left armpit (lymphnode) same side as injection; around noon - the fever started to break but remained elevated (101.7-101F); remaine din the low 100's all day with being on ibuprofen/acetaminophen and still achy/headaches but not unbearable About 48 Hours later - woke up at 3 AM with another 101 F - went to work but left around 9 AM not feeling well (may just have been from exhaustion from not sleeping well the previous 2 nights); lymphnodes still swollen and painful; 101 F around 7-8 PM About 72 hours later - no fevers, feeling better; developed rash on left arm below injection site (red, slightly raised, warm to touch, painful to touch but not itchy), lymph node still painful but not as big About 96 hours later - rash same size, slightly swollen, painful to touch; lymph node smaller in size but still painful to touch
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| 37 | 2021-01-12 | fever | body aches, fever. called in sick to work. |
| 37 | 2021-01-12 | sweating |
nausea; vomiting; significant amount of diaphoresis; sudden onset of joint pain in upper torso invol...
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nausea; vomiting; significant amount of diaphoresis; sudden onset of joint pain in upper torso involving fingers, elbows, and shoulders; Pain progressed into lower body; enlargement of the right supraclavicular lymph node; This is a spontaneous report from a contactable pharmacist(patient). A 37 years old female patient received second dose BNT162B2, Intramuscular on 05Jan2021 11:30 at the 37 years old at Arm Right at single dose for COVID-19 immunization. The medical history included Asthma and Seasonal Allergies. The concomitant medications were not reported. The patient previously took fist dose BNT162B2 on 16Dec2020 12:00 PM, Intramuscular at Arm Right at 37 years old for COVID-19 immunisation. The patient developed sudden onset of joint pain in upper torso involving fingers, elbows, and shoulders approximately 11 to 12 hours post immunization on 05Jan2021 23:00. Pain progressed into lower body throughout the night on 05Jan2021 23:00. The next morning, the pain increased to a point which caused severe nausea and vomiting on 06Jan2021. The patient received Toradol and Zofran to ease symptoms. After which, her husband was called to transport me home from work. The next 24 hours, the patient rested. During which, the patient experienced a significant amount of diaphoresis on 06Jan2021. Forty-eight hours later, my symptoms are improving. I am sore, but functional. The only new occurrence is enlargement of the right supraclavicular lymph node in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not Allergies to medications, food, or other products. The outcome of events was recovering. The information on the batch number has been requested.
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| 37 | 2021-01-13 | fatigue, dizziness, discomfort, weakness |
"Just wanted to pass along that after my second dose on 1/12/21 I experienced the following. 15 minu...
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"Just wanted to pass along that after my second dose on 1/12/21 I experienced the following. 15 minutes post vaccine, my tongue went numb for approximately 30 minutes, then it resolved. 6 hours post vaccine I became very dizzy and flushed and began to feel achy. The following morning I felt well enough to come into work but then felt increasingly weak, achy, and tired and had to go home at 12pm. All side effects were resolved by 5pm. "
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| 37 | 2021-01-13 | dizziness, shortness of breath |
1/11-arm soreness, feeling of warmth in head and neck 1/12 Elevated heart rate, SOB, dizziness, body...
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1/11-arm soreness, feeling of warmth in head and neck 1/12 Elevated heart rate, SOB, dizziness, body aches 1/13-elevated heart rate, SOB, dizziness--slightly better than 1/12 1/13-symptoms subsided
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| 37 | 2021-01-13 | fever, fatigue, headache |
1/11/2021 - stomach pain, headache, exhaustion, arm pain 1/12/2021- fever 100.0 and diarrhea for 3 d...
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1/11/2021 - stomach pain, headache, exhaustion, arm pain 1/12/2021- fever 100.0 and diarrhea for 3 days Took ibuprofen
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| 37 | 2021-01-13 | headache, fever, malaise, fatigue, chills |
1/13-malaise, mild headache, chills, joint pain, body aches, low grade temp (99.7) 1/14 worsening ex...
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1/13-malaise, mild headache, chills, joint pain, body aches, low grade temp (99.7) 1/14 worsening exhaustion, body aches, head/neck pain, chills, afebrile.
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| 37 | 2021-01-13 | fever, chills |
Body aches; Fever; Chills; Nausea; This is a spontaneous report from a contactable healthcare profes...
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Body aches; Fever; Chills; Nausea; This is a spontaneous report from a contactable healthcare professional (HCP), the patient. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the left arm on 06Jan2021 at 09:15 (at the age of 37-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included IBS (irritable bowel syndrome) and known allergies possibly penicillin related drugs. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021 at 21:00, the patient experienced body aches, fever, chills, and nausea. No treatment was provided for the events body aches, fever, chills, and nausea. The outcome of the events body aches, fever, chills, and nausea was recovering. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 37 | 2021-01-13 | fatigue, headache | Extreme fatigue Headaches Swollen lymph node left armpit size of soft ball very sore |
| 37 | 2021-01-13 | fatigue |
Fatigue; Severe body aches; This is a spontaneous report from a contactable nurse (patient). A 37-ye...
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Fatigue; Severe body aches; This is a spontaneous report from a contactable nurse (patient). A 37-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular in the right arm on 04Jan2021 17:30 at a single dose for COVID-19 immunization at the hospital. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had severe body aches and fatigue on 06Jan2021 04:00 (also reported as about 36 hours after injection). Treated at home with rest, increased fluids, and Ibuprofen 800mg. The patient fully recovered at 72 hours post-vaccine. Outcome of the events was recovered in Jan2021. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 37 | 2021-01-13 | fever, headache, fatigue, chills | Fever (100), body aches, headache, chills, fatigue |
| 37 | 2021-01-13 | headache, fatigue, fever | Fever, body aches, HA mild diarrhea , fatigue . Tylenol with improvement. |
| 37 | 2021-01-13 | chills, fever, headache | Headache, 101.4 fever, chills and achy sensation |
| 37 | 2021-01-13 | skin warm |
Itching red rash that is painful and warm to touch. Benadryl cream placed for itching, followed by h...
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Itching red rash that is painful and warm to touch. Benadryl cream placed for itching, followed by hydrocortisone cream and advil.
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| 37 | 2021-01-13 | shortness of breath | Left sided chest pain and difficulty breathing approximately 5 minutes after vaccination. |
| 37 | 2021-01-13 | headache |
On 1/9 had cold sore outbreak on right lower lip (not new). On 1/11 at 0730 started having changes ...
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On 1/9 had cold sore outbreak on right lower lip (not new). On 1/11 at 0730 started having changes in hearing mostly in right ear (never happened before) Also started having headache and red/swollen area below right eye. Uncertain of all related to cold sore or possible vaccine side effect?? Never had other symptoms with cold sore outbreak
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| 37 | 2021-01-13 | headache |
Received vaccine approx 4:25pm. At approx 4:50pm, while driving home, I started to feel "off", like...
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Received vaccine approx 4:25pm. At approx 4:50pm, while driving home, I started to feel "off", like something was wrong. Part of my tongue started to feel a bit tingly and itchy. I arrived home approx 5 minutes later, and took Diphenhydramine 50mg po. Parts of my tongue still felt tingly and itchy, and the right side towards the back was starting to feel a little swollen. I decided to have EMS bring me to the hospital in case I was having an allergic reaction. EMS arrived to my house at approx 5:15pm. My BP was significantly elevated (160's/90's - I am usually 110's/60's), and I was tachycardic at approx 100-105bpm (I am usually 70-80bpm). I had started to feel like the back of my throat was tightening a little bit. I did not have wheezing or severe difficulty breathing, or generalized itching, hives, or flushing. Once on the ambulance my throat was feeling tighter, so they administered Epinephrine 0.3mg IM, inserted an IV, and administered Dexamethasone 10mg IV. After a few minutes the tightness in my throat was gone and I was feeling more back to normal. BP and HR began to slowly trend down (BP 130's/80'sjust prior to arrival to hospital). I was seen by Nursing and a Provider shortly after arrival to the ED. My BP was still elevated (140's/90's) and HR was approx 90bpm. Provider stated that my posterior pharynx was not swollen. I was observed in the ED for approx 2.5 hours, and was discharged to home with instructions to take Diphenhydramine as needed and follow-up with my PCP within two days. BP and HR had normalized prior to discharge. They did not do any labs or tests (12-lead EKG was done by EMS en-route). The following day (today) I am tired and have a slight headache and occasional slight nausea but otherwise feel ok.
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| 37 | 2021-01-13 | malaise, fatigue, chills, headache |
Severe chills/severe shaking, tiredness, headache, muscle pain, pain at injection site, nausea, not ...
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Severe chills/severe shaking, tiredness, headache, muscle pain, pain at injection site, nausea, not feeling well. I had to stay home from work the day after the vaccine, I stayed in bed all day with a space heater on to 90 degrees in my bedroom just to get rid of the chills, I took Motrin 800 mg around the clock, Zofran as needed and I drank a lot of water.
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| 37 | 2021-01-13 | shortness of breath | Shortness of breath Chest pain Ongoing since |
| 37 | 2021-01-13 | headache |
Soreness to injection site; Headache, mild; This is a spontaneous report from a contactable nurse, t...
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Soreness to injection site; Headache, mild; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration, on 07Jan2021 at 17:00 PM (at the age of 37-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, and polycystic ovaries. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included cetirizine hydrochloride (ZYRTEC), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), ubidecarenone (COQ10). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food, or other products. On 07Jan2021 at 21:00 PM, the patient experienced headache, mild. It started 4-5 hours after, continued to next day. The next day, 08Jan2021 the patient experienced soreness to injection site. The events were reported as non-serious. The patient did not receive any treatment for the headache, mild and soreness to injection site. The clinical outcome of the events headache, mild and soreness to injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the Lot/Batch number has been requested
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| 37 | 2021-01-13 | throat swelling |
after 10 minutes developed sensation of throat swelling, tongue tingling and facial flushing: transf...
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after 10 minutes developed sensation of throat swelling, tongue tingling and facial flushing: transferred to ED: no intervention, observed for 3 hrs & d/cd
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| 37 | 2021-01-13 | chills | body aches and chills 1/14 all day |
| 37 | 2021-01-13 | headache, fatigue, chills | body aches, chills, nausea, headache, fatigue, took Tylenol |
| 37 | 2021-01-13 | cough, nasal congestion, runny nose |
covid test result=Positive; covid test result=Positive; nasal congestion; sneezing runny nose; sneez...
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covid test result=Positive; covid test result=Positive; nasal congestion; sneezing runny nose; sneezing runny nose; sinus pressure; dry cough; This is a spontaneous report from a contactable Nurse (patient herself). This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), via an unknown route, on 19Dec2020 at 16:15 at single dose for COVID-19 immunisation. Vaccine location was arm left. The patient was not pregnant. The patient was vaccinated at hospital, age at vaccination was 37-year-old. No other vaccine was received in four weeks. No relevant medical history was provided. Relevant concomitant medications included amoxicillin sodium, clavulanate potassium (AUGMENTIN, formulation: tablet) at dose of 875 mg twice daily from an unknown. Pre-vaccination COVID test was not performed. On 25Dec2020 at 20:00, the patient complained of nasal congestion, sneezing runny nose, sinus pressure, and cough. On 28Dec2020, COVID test Nasal Swab (SOFIA SARS ANTIGEN FIA/QUIDEL) was performed and resulted positive. She was given oral azithromycin 500 mg 1 tab Daily and oral benzonatate (TESSALON PERLES) 1 Capsule three times a day (TID). The symptoms of nasal congestion, sneezing runny nose, sinus pressure, and cough were improving. The outcome of 'COVID test result=Positive' was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and SARS-CoV-2 test positive cannot be ruled out.
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| 37 | 2021-01-13 | cough, headache, weakness |
headaches, body aches, cough, lower energy, poor sleep took ibuprofen and/or tylenol for the first 2...
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headaches, body aches, cough, lower energy, poor sleep took ibuprofen and/or tylenol for the first 24 hours to reduce symptoms of aches (alternated every 4 hours). took two days for symptoms to reduce completely
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| 37 | 2021-01-13 | chills | sever emesis, chills |
| 37 | 2021-01-14 | headache |
12/30/2020- 5 minutes after receiving vaccination pt c/o throat tingling and tightening. Then 10 mi...
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12/30/2020- 5 minutes after receiving vaccination pt c/o throat tingling and tightening. Then 10 minutes later began having headache. Sent to ED- EKG completed, and pt was monitored. Declined Benadryl. Apx 5-7 pm that night when at home pt decided to take a half dose of OTC Benadryl. pt woke in middle of night still with headache-took Advil. When woke in the morning had diarrhea and stomach discomfort- lasted apx 24 hours. Then beginning on 01/04/2021 pt noticed the sensation of having a burned tongue and roof of mouth.- is constant and sensitive to heat. pt reports that intermittently in the evening she is also getting the sensation of tongue and throat swelling- denies any SOB and denies actual swelling just sensation.
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| 37 | 2021-01-14 | chills, headache |
20 MINS INTO COOL FLUSH FEELING ALL OVER , HEART RACING , WENT HOME AND HAD REALLY BAD HEART PALPUT...
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20 MINS INTO COOL FLUSH FEELING ALL OVER , HEART RACING , WENT HOME AND HAD REALLY BAD HEART PALPUTATIONS , CALLED THE NURSE . EKG WAS NORMAL .. Blood pressure was 130/99 which is higher than normal ..Provided IV FLUIDS . HEADACHES, NASUEA ,CHILLS.
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| 37 | 2021-01-14 | headache, chills |
2nd vaccine given on Saturday 1/9 at 1030. Woke up with severe body aches, shivering, headache, naus...
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2nd vaccine given on Saturday 1/9 at 1030. Woke up with severe body aches, shivering, headache, nausea on Sunday morning at 02:30. This continued the rest of the day but was improved with Aleve. Woke up on Monday feeling well. Monday afternoon started developing a rash on bilateral thighs and arms. The rash was itchy and inflamed. Took Benadryl 12.5mg the next 2 nights. Wednesday the rash had improved, still pinkish but not red. Thursday the redness had resolved, but was still itchy. The itching continues today, but very mild.
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| 37 | 2021-01-14 | chills, headache, fever |
At 2000 on 1/13/21, I started to experience intense ache at the injection site, which by 2200 progre...
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At 2000 on 1/13/21, I started to experience intense ache at the injection site, which by 2200 progressed to myalgias in my back, especially lower back, neck, and right arm. At 2300, I started to have fever/chills, up to 39 C orally. This only partially responded to Tylenol. I was not able to sleep. At 2:30 am I noticed an unusual headache, 8/10, as well as bilateral eye pain on Moving eyes side to side as well as sensitivity to light. Headache was mostly frontal, which came and went every few minutes until exactly 11:38 am on 1/14/2021, when the fever and myalgias very suddenly got significantly better. Almost exactly 24 hrs to the minute after injection. On 1/15/2021, I still have significant pain in my left arm, swelling, redness and, now, itching at the injection site. My lower back still hurts.
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| 37 | 2021-01-14 | dizziness |
Awoken by chest pain at 1am on 1.15.2021. Went to ER - unsure if anxiety attack, heart attack or rel...
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Awoken by chest pain at 1am on 1.15.2021. Went to ER - unsure if anxiety attack, heart attack or related to COVID vaccination on 1.12.2021. Also complains of dizziness, and nausea. Cardiac workup performed. Ativan relieved her symptoms. No remarkable findings and patient was discharge back home at 06:30 1.15.2021.
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| 37 | 2021-01-14 | night sweats, headache, fatigue, dizziness, weakness, chills |
Chills; Night Sweats; Body Aches; Dizziness; Headache; fatigue; weakness; joint pain; nausea; This i...
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Chills; Night Sweats; Body Aches; Dizziness; Headache; fatigue; weakness; joint pain; nausea; This is a spontaneous report from a contactable health care professional, the patient. A 37-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK9231), in the right arm on 30Dec2020 13:00 as a single dose, for COVID-19 vaccination. The vaccine was administered at a Pharmacy or Drug Store. Medical History include drug allergy to sulfa. Concomitant medication included Microgestin, Biotin and Prenatal Vitamin. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 31Dec2020 , the patient experienced Chills, Night Sweats, Body Aches, Dizziness, Headache, fatigue, weakness, joint pain, nausea. No treatment was received given for the event. The clinical outcome of Chills, Night Sweats, Body Aches, Dizziness, Headache, fatigue, weakness, joint pain, nausea was recovering.
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| 37 | 2021-01-14 | sweating, chills, fever, dizziness |
Employee received second dose of Pfizer COVID vaccine on 1/13/2021 at 1400. Employee had a syncope e...
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Employee received second dose of Pfizer COVID vaccine on 1/13/2021 at 1400. Employee had a syncope episode on 1/14/2021 around 1300. Employee called the nurse on 1/15/2021 at 0840 to report syncope. Employee denies any current dizziness, nausea or vomiting.
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| 37 | 2021-01-14 | fatigue, fever |
Fever (T-Max was 100.9); body aches; fatigue; This is a spontaneous report from a contactable nurse ...
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Fever (T-Max was 100.9); body aches; fatigue; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), via an unspecified route of administration in the right arm, on 18Dec2020 at 10:30 (at the age of 37-years-old) at a single dose for COVID-19 immunization. Medical history included COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not receive any other mediations within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever (temperature maximum (T-Max) was 100.9), body aches, and fatigue on 18Dec2020 at 13:30. The events were reported as non-serious. The patient underwent lab tests and procedures, which included body temperature: T-Max of 100.9 on 18Dec2020 and nasal swab: negative on 04Jan2021. The patient did not receive any treatment for the events. The clinical outcome of fever (T-Max was 100.9), body aches, and fatigue was recovered on 19Dec2020 at 22:30.
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| 37 | 2021-01-14 | fatigue, fever |
Fever max of 104; Body aches; Fatigue; This is a spontaneous report from a contactable nurse (patien...
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Fever max of 104; Body aches; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration; first dose (lot EH9899) on 16Dec2020 19:00 (07:00 P.M.) and then the second dose (lot EJ1685) on 06Jan2021 08:00 A.M.; both at a single dose on the left arm as COVID vaccine. Medical history included hypertension; known allergies to sulfa, milk, and iv contrast. Concomitant medications were not reported. The patient had known allergies to doxycycline, morphine, oxycodone hydrochloride/oxycodone terephthalate/paracetamol (TYLOX), and ceftriaxone sodium (ROCEPHIN). The patient experienced fever max of 104 with Motrin and Tylenol 2 days, body aches, fatigue, all on 06Jan2021 19:00 that were assessed as non-serious in which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The events resulted to a doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. She was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). She did not receive other vaccines within four weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. She was not diagnosed with COVID-19 prior to vaccination. She had been tested for COVID-19 since the vaccination in which lab data included nasal swab Send off pending results and rapid test was negative, both on 08Jan2021. Therapeutic measures were taken as a result of fever max of 104 while treatment was not received for the rest of events. The outcome of the events was recovering.
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| 37 | 2021-01-14 | fever, headache |
Full body aches and fever 12 hours after vaccine, lasted 2 hours, relieved by acetaminophen and ibup...
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Full body aches and fever 12 hours after vaccine, lasted 2 hours, relieved by acetaminophen and ibuprofen. Daily headaches and nausea since second dose administration. Ibuprofen and acetaminophen PRN for headaches. No treatment for nausea. Headaches and nausea are still ongoing.
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| 37 | 2021-01-14 | chills, fatigue, headache |
Mild headache and fatigue 1/13 after the vaccine administration 1/14 starting around 1400: increase...
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Mild headache and fatigue 1/13 after the vaccine administration 1/14 starting around 1400: increase in muscle aches, headache, fatigue and chills rested and took motrin Expected site pain
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| 37 | 2021-01-14 | migraine, respiratory tract congestion, fatigue |
Severe Migraine 10/10 lasting 24 hours (felt like my head was going to explode ice applied to my ey...
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Severe Migraine 10/10 lasting 24 hours (felt like my head was going to explode ice applied to my eyes and next), Nausea, Body aches lasting 24 hours ( could not move without help pain 8/10), congestion, fatigue.
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| 37 | 2021-01-14 | fever, fatigue |
Sore Arm, Achy, Tired, Fever; some symptoms started about one hour after injection and lasted for ap...
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Sore Arm, Achy, Tired, Fever; some symptoms started about one hour after injection and lasted for approx. 36 hrs.
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| 37 | 2021-01-14 | fatigue, chills, fever |
The morning after my second vaccine dose, I experienced severe fatigue, fever of 101 degrees F, musc...
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The morning after my second vaccine dose, I experienced severe fatigue, fever of 101 degrees F, muscle aches, and chills. These symptoms resolved 30 hours post vaccination.
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| 37 | 2021-01-14 | headache, fatigue, malaise, fever |
Tiredness; headache; muscle pain; fever; feeling unwell; nausea; joints pain; injection site swellin...
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Tiredness; headache; muscle pain; fever; feeling unwell; nausea; joints pain; injection site swelling/redness; injection site swelling/redness; This is a spontaneous report from a contactable nurse. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),Batch/lot number: EK9231, intramuscular in the right arm, from 07Jan2021 07:45 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 08Jan2021 02:30, the patient experienced tiredness, headache, muscle pain, fever, feeling unwell, nausea, joints pain and injection site swelling/redness. The outcome of events was not recovered. No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
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| 37 | 2021-01-14 | weakness, chills, fatigue, fever |
Very sore left arm the next day after injection. The next day after injection had chills, hot flashe...
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Very sore left arm the next day after injection. The next day after injection had chills, hot flashes, and low grade temperature of 99. Was restless and unable to sleep on the night of the 13th. Also had lower back pain as well as low energy and overall tired feeling. These symptoms lasted until the later morning of the 14th. Ibprofun was taken.
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| 37 | 2021-01-14 | runny nose, headache, nasal congestion |
congestion; headache; running nose; This is a spontaneous report from a contactable Nurse reporting ...
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congestion; headache; running nose; This is a spontaneous report from a contactable Nurse reporting for herself. A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1686) via an unspecified route of administration on left arm, on 06Jan2021, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were reported as none. On 10Jan2021, the patient experienced congestion, running nose and headache. The headache comes and goes. Outcome of the events congestion and headache was recovering at the time of the report while it was unknown for running nose.
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| 37 | 2021-01-14 | fever | fever. called in sick to work. |
| 37 | 2021-01-14 | headache, fatigue, dizziness |
muscle pain, lightheadedness (comes and goes), nauseau (off and on), headache, right sinus/ ear pain...
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muscle pain, lightheadedness (comes and goes), nauseau (off and on), headache, right sinus/ ear pain, insomnia, faint chest pain, numbness right arm and leg, diarrhea, wheezing (off and on), fatigue.
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| 37 | 2021-01-14 | body temperature increased, fatigue, headache, chills | rigorous chills, temp of 101.6, headache, body ache and fatigue |
| 37 | 2021-01-14 | cough |
~10pm, tickle in throat ~ Midnight dry cratchy cough related to tickle in throat ~10pm, itchy wrist...
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~10pm, tickle in throat ~ Midnight dry cratchy cough related to tickle in throat ~10pm, itchy wrists, bilaterally, progressed to back of neck, insides of arms, lower legs, tops of feet, upper chest, under breasts, and splotchy face. ~10-midnight - rash in all same areas of itchiness
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| 37 | 2021-01-16 | chills, headache, fever |
Facial numbness (left nare, left side upper lip) started approximately 20 min post vaccine and laste...
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Facial numbness (left nare, left side upper lip) started approximately 20 min post vaccine and lasted approximately 45 minutes. Headache, Fever (Tmax 101.8), aches, chills started at 0330 day after vaccine given 1400 day prior to symptoms , ended by 2100 day after vaccine.
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| 37 | 2021-01-17 | fatigue, pneumonia, malaise |
7 days later diagnosed with pneumonia; 3 days after developed hives on my stomach and arm; felt tire...
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7 days later diagnosed with pneumonia; 3 days after developed hives on my stomach and arm; felt tired; confused; unwell; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730), via an unspecified route of administration on the left arm on 28Dec2020 12:00PM at a single dose for COVID-19 immunization at hospital facility. Medical history included Hashimotos disease. The patient had no known allergies and has not had COVID prior to vaccination. The patient's concomitant medications were not reported. The patient reported that she felt tired and confused and unwell on day of injection, 28Dec2020. After three days (31Dec2020), she developed hives on her stomach and arm and seven days later (04Jan2021), she was diagnosed with pneumonia and continued to have hives all over her legs and arms to this day. The patient was treated with antibiotics for pneumonia. She underwent Covid test/ Nasal swab post vaccination on 09Jan2021, pending result. The outcome of the events was not recovered.; Sender's Comments: The reported pneumonia was more likely an intercurrent disease, and unlikely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 37 | 2021-01-17 | chills, headache |
unilateral cervical lymphadenopathy; seemed to start developing within 24-48 hours after the shot, m...
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unilateral cervical lymphadenopathy; seemed to start developing within 24-48 hours after the shot, more noticeable at 72 hours with the pain already improving; myalgia; headache; chills; This is a spontaneous report from a non-contactable physician. A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The healthy female patient complained about a unilateral cervical lymphadenopathy (self-examined) on the left side (the same side as the 2nd vaccine shot on Friday 08Jan2021), yesterday evening (Sunday, 10Jan2021). It seemed to start developing within 24-48 hours after the shot, more noticeable at 72 hours with the pain (Jan2021) already improving. She also developed myalgia, headache and chills 12-18 (Jan2021) after the shot. All the other symptoms were somewhat anticipated, but the lymphadenopathy was not. She doesn't have any other conditions. The outcome of lymph node pain was recovering, while the outcome of the remaining events was unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
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| 37 | 2021-01-18 | fatigue, discomfort |
Felt tachycardia immediately, thought she was anxious. After 35-45 minutes she felt like she was hav...
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Felt tachycardia immediately, thought she was anxious. After 35-45 minutes she felt like she was having a hard time swallowing which progressed to tongue swelling, all taste buds popped up and sore, hives on face & neck, reddened face. Itchy neck and face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling all over body. Woke up feeling heaviness as if she had "sumo wrestler" on her body. 24 hours post vaccine heaviness started to lift but felt as if she had a vise on her lungs. Continuing to take Atarax every 6 hours per MD order.
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| 37 | 2021-01-19 | chills, fever, fatigue, headache |
1st dose had injection site reaction that lasted 1 week, mild headache and mild muscle aches fatigue...
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1st dose had injection site reaction that lasted 1 week, mild headache and mild muscle aches fatigue that lasted less than 8 hrs. 2nd dose had muscles aches, chills, nausea/vomiting, fever up to 101.5 F lasted 24 hours
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| 37 | 2021-01-19 | headache, chills |
8 hrs after vaccine staff started to have chill and bodyache and last upto 75 hrs. Around 50hrs sta...
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8 hrs after vaccine staff started to have chill and bodyache and last upto 75 hrs. Around 50hrs started to have headache and it disappeared at about 80 hrs. Would like to report the symptoms, reactions. Feels well today and has been back to work.
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| 37 | 2021-01-19 | dizziness, fever, headache, chills | Chills, Body ache, Headache, Dizziness, Fever. |
| 37 | 2021-01-19 | fever, chills | Fever, chills, diarrhea, swollen armpit on side shot was given, swollen in a where shot was given. |
| 37 | 2021-01-19 | lethargy, headache |
Generalized muscle weakness, lethagy, body aches, headache, injection site erythema, redness, and mo...
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Generalized muscle weakness, lethagy, body aches, headache, injection site erythema, redness, and moderate pain. Injection site reaction is approximately 2cm x 3cm.
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| 37 | 2021-01-19 | malaise, headache |
Injection site was red, very painful, and swollen. About 30 hrs after injection I experienced joint...
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Injection site was red, very painful, and swollen. About 30 hrs after injection I experienced joint pain, overall not feeling well, and chest tightness (different than my last anxiety attack). 12 hours later those symptoms were gone but then I had a headache and nausea that resolved shortly after.
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| 37 | 2021-01-19 | sweating, fever, chills, headache |
Patient describes chills, shivering, fever, headache, stomach issues, sweating and hot flashes. Sums...
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Patient describes chills, shivering, fever, headache, stomach issues, sweating and hot flashes. Sums headaches up to have last 3 days. Also includes body aches.
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| 37 | 2021-01-19 | chills, dizziness, fatigue, headache |
Severe body aches, chills, fever 103, fatigue dizziness, headache - symptoms lasted 2days, the thir...
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Severe body aches, chills, fever 103, fatigue dizziness, headache - symptoms lasted 2days, the third day I had diarrhea and nausea.
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| 37 | 2021-01-19 | influenza like illness, shortness of breath, fatigue, headache |
Started off getting very itchy, then hives developed, and I turned red, I became very hot...24 hours...
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Started off getting very itchy, then hives developed, and I turned red, I became very hot...24 hours later I had flu like symptoms along with a blistering rash on my neck, face and scalp..with a few spots on my chest and back. These started to heal 5 days after injection, then started to resurface. On Day 3 I started getting short of breath and intermittent chest pains accompanied by a heart rate ranging from 110 to 126. I developed a severe headache and fatigue.
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| 37 | 2021-01-21 | chills |
12 hours - Slight Nausea 24 Hours - Moderate Nausea 24-36 hours - Moderate Chills/Aches By 36 hours...
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12 hours - Slight Nausea 24 Hours - Moderate Nausea 24-36 hours - Moderate Chills/Aches By 36 hours I felt 100% normal again.
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| 37 | 2021-01-21 | headache, fever, chills | DEVELOPED BODY ACHES, FEVER, CHILLS, AND HEADACHE LASTING 24 HOURS. |
| 37 | 2021-01-21 | fatigue, headache | Fatigue, achiness, headache, sore arm for about 24 hours |
| 37 | 2021-01-21 | headache, chills |
STARTED FEELING CHILLS, BODY ACHES, HEADACHE, AND NAUSEA. LOSS OF APPETITE. TOOK TYLENOL EVERY 4 HRS...
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STARTED FEELING CHILLS, BODY ACHES, HEADACHE, AND NAUSEA. LOSS OF APPETITE. TOOK TYLENOL EVERY 4 HRS AND PLENTY FLUIDS.
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| 37 | 2021-01-24 | shortness of breath |
Began medication (follitropin 200 units) for assisted reproductive technology on evening of 01/02/21...
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Began medication (follitropin 200 units) for assisted reproductive technology on evening of 01/02/21. Added ganirelix injections on 01/06/21. Trigger injection with leuprolide administered at 20:00 on 01/11/21. Immediately prior to oocyte retrieval on 01/13/21, given 1L IVF and ampicillin (dose unknown) at approx. 07:30am. Retrieval at 08:00am was uneventful, but notable for 17 oocytes retrieved and only 10 were mature. Post-procedure vitals were WNL. Discharged home from facility (Family Health Center) at approx. 09:30am. At approx. 12:00pm, noted increasing abdominal girth. At approx. 14:00, noted mild shortness of breath. Abdominal distention and shortness of breath continued to worsen. Unable to recline even moderately due to difficulty breathing.
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| 37 | 2021-01-24 | fatigue, headache | Extreme exhaustion, nausea, significant headache that has been going since 1/20/21 to present day |
| 37 | 2021-01-24 | headache |
Initially she was fine during 15 minutes observation period. Facial redness/itching developed around...
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Initially she was fine during 15 minutes observation period. Facial redness/itching developed around 15-20 minutes after shot on 1/7/21. No rash anywhere else on body. Numbness in face. Headache. Per patient, co-nurses told her she had facial swelling. No trouble breathing. No throat swelling. No cough. Got famotidine and Benadryl. blood pressure was elevated (228/120). She felt better after about 2 hours.
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| 37 | 2021-01-24 | dizziness, chills, headache, fever |
Mental fog; Chills; Dizziness sensation; Headache; Extremely large lymph nodes; Fevers; This is a sp...
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Mental fog; Chills; Dizziness sensation; Headache; Extremely large lymph nodes; Fevers; This is a spontaneous report from a contactable nurse reported for self. This 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 08Jan2021 12:00 PM at single dose in right arm for COVID-19 immunization. The patient is not pregnant. The patient had no COVID prior vaccination. The patient had none known allergies. The patient medical history included hypertension/ gastric sleeve 2020. The patient concomitant mediations included metoprolol 100mg once a day. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 18-Dec-2020 12:00 PM at single dose in right arm for COVID-19 immunization. The patient experienced extremely large lymph nodes, chills, fevers, Constant headache and dizziness sensation, mental fog. The events onset date was reported 08-Jan-2021 20:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit. The COVID test post vaccination (COVID test type Nasal Swab, COVID test name COVID/flu AB by PCR) resulted Negative on 11-Jan-2021. The patient received no treatment. The outcome of events was recovering. Information on the Lot/batch number has been requested. Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported mental fog and the administration of the suspected vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 37 | 2021-01-25 | lethargy, headache |
I was puking, lethargic, headache, body aches from Dec. 30- Jan. 2. On Jan 2, 2021 I went to the ER....
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I was puking, lethargic, headache, body aches from Dec. 30- Jan. 2. On Jan 2, 2021 I went to the ER. I was given sodium chloride, nausea med and an allergy med.
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| 37 | 2021-01-25 | fatigue, chills, fever |
Red welts/hives; blisters; rash started on feet, legs arms and buttocks within 12-20 hrs; nausea; fe...
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Red welts/hives; blisters; rash started on feet, legs arms and buttocks within 12-20 hrs; nausea; fever; chills; fatigue; Right foot swollen with blisters; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the second dose of BNT162b2 (lot number: Ek4176), via an unspecified route of administration in left arm on 09Jan2021 15:00 at single dose for covid-19 immunization. Medical history included depression, irritable bowel syndrome (IBS). Concomitant medication included venlafaxine hydrochloride (EFFEXOR), desogestrel, ethinylestradiol (APRI), cetirizine hydrochloride (ZYRTEC), loratadine (CLARITIN), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC) , ibuprofen (MOTRIN). The patient previously took tramadol and cranberry and both experienced allergies. The patient previously received the first dose of BNT162b2 (lot number: Ek5730), at the age of 37-year-old, via an unspecified route of administration in left arm on 20Dec2020 15:00 at single dose for covid-19 immunization. The patient experienced red welts/hives/blisters/rash started on feet, legs arms and buttocks within 12-20 hrs. And nausea, fever, chills, fatigue. Right foot swollen with blisters. The above events were occurred on 10Jan2021 and received the treatments Steroid cream and atarax. The above events resulted in Emergency room/department or urgent care. The outcome of the events were not recovered.
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| 37 | 2021-01-26 | pneumonia, influenza like illness | Flu like symptoms Saturday/Sunday /Monday Went to urgent care diagnosed with Covid and pneumonia |
| 37 | 2021-01-26 | headache, nasal congestion, runny nose, fatigue |
From midnight on the 26th through approx 2pm on the 26th: headache, restlessness, intermittent nause...
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From midnight on the 26th through approx 2pm on the 26th: headache, restlessness, intermittent nausea, nasal congestion then runny nose and overall fatigue feeling.
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| 37 | 2021-01-26 | fatigue | Intense fatigue, rapid heart beat, chest pain, mental fog |
| 37 | 2021-01-26 | malaise, headache, fatigue |
Its been a little over 2 weeks; Since the 2nd dose I have had swollen lymph nodes, head aches and fe...
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Its been a little over 2 weeks; Since the 2nd dose I have had swollen lymph nodes, head aches and feeling fatigue. I have not been well. My Axilla Lymph nodes became so swollen that it has caused me to have urgent ultrasound and even a lymph nodes biopsy. Including, I have taken Tylenol Extra Strength for headaches and even Advil Migraine. Also - Since the Injection My right Arm has continued to be soar and still a bit swollen. 01/27/2021 .
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| 37 | 2021-01-26 | fatigue, headache | Myalgia (specifically arm, neck and back soreness), headache, fatigue |
| 37 | 2021-01-26 | head discomfort | Preasure in head and neck as well as inflammation |
| 37 | 2021-01-26 | chills |
Sore arm and back pain starting 4 hours after injection , chills and abdominal cramping 11 hours aft...
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Sore arm and back pain starting 4 hours after injection , chills and abdominal cramping 11 hours after vaccination administered Sore arm - lasted 4 days Back pain - lasted 2 days Chills and abdominal cramping lasted 2 hours
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| 37 | 2021-01-26 | body temperature increased, headache |
Woke up with headache, Temp = 101, chills, whole body shaking during night 1/7/21 in am temp = 99, n...
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Woke up with headache, Temp = 101, chills, whole body shaking during night 1/7/21 in am temp = 99, no further chills
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| 37 | 2021-01-26 | cold sweat, shortness of breath |
dyspnea; myalgias; chest pain/Chest pain is moderately severe and worse with deep inspiration; back ...
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dyspnea; myalgias; chest pain/Chest pain is moderately severe and worse with deep inspiration; back aches; feeling clammy; This is a spontaneous report from a contactable pharmacist. A 37-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3248, expiration date unspecified), via an unspecified route of administration on 11Jan2021 12:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 21Dec2020 and experienced fever, chills, myalgias, and some sensory changes to the left arm; and vancomycin and experienced allergies. On 11Jan2021, the patient experienced dyspnea and myalgias following her second vaccination today. It was reported that she received the second dose of the vaccine around noon and then began having dyspnea and chest pain around an hour later. Chest pain was moderately severe and worse with deep inspiration. Patient was also having back aches and was feeling clammy. Patient represented to the vaccine site and was brought to the emergency room department/urgent care for evaluation. Patient denied any history of vaccine associated reactions. The patient received therapy for the events which included acetaminophen, ketorolac and intravenous (IV) fluids. The patient had no other vaccine in four weeks. Outcome of events was unknown.; Sender's Comments: Based on the time association, the events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 37 | 2021-01-26 | chills, headache, fever |
itching; frontal headache; eye pain on movement; sensitivity to light; arthralgias (wrists, ankles);...
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itching; frontal headache; eye pain on movement; sensitivity to light; arthralgias (wrists, ankles); nausea; chills; fever/chills (up to 39 C); myalgias in the back and contralateral arm; left arm soreness; Redness and swelling at injection site; Redness and swelling at injection site; Lower back pain; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot: EK9231) on 13Jan2021 11:45 at a single dose for covid-19 immunization. Medical history included GERD (gastrooesophageal reflux disease), environmental allergies, Penicillin (but not augmentin) allergies and sulfa allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC), esomeprazole, and vitamin d. Histrical vaccine included the first dose of BNT162B2 (lot number: EJI685) on 23Dec2020 12:15 in the left arm, for covid-19 immunization. On 13Jan2021 20:00, patient experienced left arm soreness. Then at 21:00, she experienced myalgias in the back and contralateral arm. At 23:00, she had fever/chills (up to 39 C). The next day (14Jan2021) at 2:30, she had frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), persistent fever and nausea. All these symptoms persisted until exactly 11:48 on 14Jan2021, when everything suddenly got better. Still occasional chills but no fever for the rest of the day, left arm pain persists into 15Jan2021. Redness and swelling at injection site are worse. There was also now itching. Lower back pain persists. The outcome of events left arm soreness, "Redness and swelling at injection site" and lower back pain was not recovering. She was recovering from " myalgias in the back and contralateral arm", fever/chills (up to 39 C), frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), nausea, chills Patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 37 | 2021-01-26 | chills, sweating |
pain at injection site - severe-starting 10 hours after lasting 5 days swelling at injection site - ...
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pain at injection site - severe-starting 10 hours after lasting 5 days swelling at injection site - starting 10 hours after - lasted 2 days chills- severe- starting 11 hours after lasting 4 hours rigors - severe- starting 11 hours after lasting 4 hours sweats - mild starting 11 hours after lasting 4 hours abdominal cramping - moderate - starting 11 hours after lasting 11 hours Nausea - starting 28 hours after injection - lasting 4 hours
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| 37 | 2021-01-28 | runny nose |
At 4:26pm patient reported that she has itchy eyes and nose and also a runny nose. Vital signs taken...
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At 4:26pm patient reported that she has itchy eyes and nose and also a runny nose. Vital signs taken. Patient given Diphenhydramine by mouth at 4:33pm. Patient was discharged to go home.
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| 37 | 2021-01-28 | chills, headache, dizziness, fever | Fever 102.5, body aches, chills, HA, dizziness |
| 37 | 2021-01-28 | headache, influenza like illness, fever |
Flu like systems, body aches, Fever, woke her out of sleep, sore lymph nodes still swollen, fever, t...
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Flu like systems, body aches, Fever, woke her out of sleep, sore lymph nodes still swollen, fever, terrible headache. Had to take off work 01/27/21 couldn't get out of bed.
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| 37 | 2021-01-28 | headache, weakness |
On 1/28 at ~1330 employee woke up from nap with chest pains. No previous history of chest pain or an...
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On 1/28 at ~1330 employee woke up from nap with chest pains. No previous history of chest pain or any other significant health issues. No medication was taken at time of vaccination or prior to appointment. Was advised to seek care. Went to urgent care and diagnosed with costochondritis. Given Toradol shot and chest pain began relieve within 30 min. 1/29 reports no chest pain, but still has weakness and persistent headache.
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| 37 | 2021-01-28 | shortness of breath, runny nose, cough, dizziness |
Persistent shortness of breath; Chest pain; Runny nose; Dry cough; Dizzy; This is a spontaneous repo...
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Persistent shortness of breath; Chest pain; Runny nose; Dry cough; Dizzy; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old female patient received the second dose of bnt162b2 (COVID-19 vaccine, brand: Pfizer) via an unspecified route of administration in right arm, on 07Jan2021 09:15 at a single dose for COVID-19 immunization in a hospital. Medical history included narcolepsy from an unknown date and unknown if ongoing and ongoing persistent shortness of breath from an unknown date. No known allergy. Concomitant medication included armodafinil, sertraline hydrochloride (ZOLOFT), and dextroamphetamine (DEXAMFETAMINE). The patient previously received the first dose of bnt162b2 on 21Dec2020 12:00 in right arm for COVID-19 immunization at age 37 years old. The patient had no COVID prior to vaccination. On 07Jan2021, the patient experienced shortness of breath, chest pain, runny nose, dry cough, dizzy. The patient had 2 ER visits and admission, and ongoing work up. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 1 day. The patient received albuterol and alprazolam (XANAX) as treatment. The patient underwent covid test post vaccination: Nasal swab on 11Jan2021 and on 12Jan2021 with both with result negative. The patient had not recovered from the events. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events shortness of breath, chest pain, runny nose, dry cough and dizzy. The patient's underlying ongoing shortness of breath and psychiatric disorder treated by sertraline may also be contributory. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 37 | 2021-01-28 | dizziness |
Pt. developed feeling of flushing and dizziness immediately after receiving the vaccine , then C/O p...
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Pt. developed feeling of flushing and dizziness immediately after receiving the vaccine , then C/O palpitations and chest tightness a few minutes later at 6:14pm. After vital signs were found to be stable and improving with reassurance her complaints resolved without medication or treatment.
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| 37 | 2021-01-28 | migraine, fever |
pain on arm/body/body; nausea; brain fog; migraine; swollen arm; pain at injection site; could not m...
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pain on arm/body/body; nausea; brain fog; migraine; swollen arm; pain at injection site; could not move; fever; increase blood pressure; chest tightness; The Vaccine vail was not mixed with Sodium Chloride prior to administration; The Vaccine vail was not mixed with Sodium Chloride prior to administration; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (15Jan2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Pharmacist. A 37-year-old female patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140, expiration date: Mar2021), via Intramuscular on left arm on 02Jan2021 at 18:00 at 0.3 mL, single for covid-19 immunisation. The relevant medical history was not reported. Concomitant medications were reported as none. The patient previously took Tylenol one hour prior to the vaccination on 02Jan2021 at 1 tablet by mouth. Patient complained of nausea, brain fog on 02Jan2021 at 06:20 pm. Pharmacist recommended to admit ER for safety and to monitor. Patient received the injection at 6pm. Patient was recommended by Pharmacist to admit ER for safety. Patient decided to admit ER at 10 pm. No other symptoms were reported from patient. The patient was admitted to hospital on 02Jan2021 and was discharged on 03Jan2021. While at the hospital, patient informed that she had fever, increased in blood pressure, and chest tightness on 03Jan2021 (reported as mid night). Patient admitted to hospital on 10 pm and was discharged the next day with ibuprofen/Tylenol/ zofran and continue to monitor for symptoms. After discharged, while at home, patient informed about migraine, swollen arm, pain at injection site and body that she could not move at 9:00 am on 04Jan2021. Patient informed that she admitted to hospital again about the pain on arm/body. The patient received 1 dose of 0.3ml and before it was possible that the vaccine was not mixed with sodium chloride prior to administration, an error due to mixture to communicate clearly adequately between our colleagues. Patient received the vaccine at 6 pm on 02Jan2021. After speaking with our colleague about 15 minutes ran to check on the patient if she was feeling okay. Patient complained feeling a bit nausea, brain fog, no other symptoms. Patient stated that she was okay. They stayed back at the store to keep track of patient to admit to ER after her shift at 10 pm. Patient informed she had fever, chest tightness, increase blood pressure at the hospital, then was discharged the next day with ibuprofen/tylenol/Zofran. The following day during at home patient complained at migraine, swollen arm, Pain at the injection site and could not move due to the pain. Patient decided to admit back to hospital for additional information about her pain. They contacted patient again after 3 days, patient informed. She was better and had returned to work on 13Jan2021. The outcome of the events was recovered on 11Jan2021. The pharmacist considered the events were related to suspect product Covid-19 by Pfizer.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported nausea, brain fog, pain on arm/body, and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 37 | 2021-01-28 | somnolence, fever |
stroke; unresponsive; unable to move one side of her body; fell down the stairs; fever; felt groggy;...
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stroke; unresponsive; unable to move one side of her body; fell down the stairs; fever; felt groggy; This is a spontaneous report from a contactable consumer and a non-contactable consumer (patient's sister). A 37-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for an covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was an oncology nurse practitioner working received the Pfizer BioNtech vaccine on Thursday 14Jan2021. On Friday 15Jan2021, the patient visited her family members and told them she had a fever and felt groggy. She went to sleep around 8pm-9pm that evening (15Jan2021). Around 2am-3am in the morning Saturday 16Jan2021, the patient fell down the stairs and her family member found her - unresponsive and unable to move one side of her body. Her family member moved her to the couch. Around 7am-7:30am, the patient was still unresponsive and unable to move one side of her body. Her family dialed an ambulance took her to an hospital. At present - her family reported that the healthcare professional they spoke to said the patient had a stroke. She had received multiple scans (MRI, brain scan) in the hospital and was awaiting a Neuro consult. It was unknown if treatment received. The outcome of events was unknown. Information about lot/batch number has been requested.
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| 37 | 2021-01-31 | chills, fatigue, headache, fever |
Severe headache; nausea; fever; chills; body aches; fatigue; This is a spontaneous report from a non...
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Severe headache; nausea; fever; chills; body aches; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration (left arm) on 23Dec2020 (14:45) at single dose for Covid-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, nausea, fever, chills, body aches, and fatigue on 24Dec2020 (12:00AM). There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
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| 37 | 2021-02-07 | weakness |
Nausea/vomiting with movement of head-3 hours after shot; loss of balance with inability to walk; na...
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Nausea/vomiting with movement of head-3 hours after shot; loss of balance with inability to walk; nausea/vomiting while sitting or attempting to stand-2 days; leg cramps/charlie horses- 3-5 days; general weakness in arms and legs- weeks/current; difficulty with fine motor movements in fingers and weakness in arms and hands-current
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| 37 | 2021-02-08 | shortness of breath, throat swelling |
Patient reports that 20 minutes after receiving vaccination that she developed throat tightness and ...
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Patient reports that 20 minutes after receiving vaccination that she developed throat tightness and swelling and associated trouble swallowing and shortness of breath. She was treated with IM Epinephrine and IV Benadryl on site and EMS transported to Emergency Department. EMS reported symptoms returned en route and 2nd dose of IM epinephrine given. In the ED, pt received a 3rd dose IM epinephrine when her symptoms worsened again, and was admitted to the hospital for monitoring overnight. She was discharged home today.
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| 37 | 2021-02-09 | chills, night sweats, malaise, fatigue, throat pain, fever, runny nose |
covid test date: 03Jan2021, covid test result: Positive; covid test date: 03Jan2021, covid test resu...
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covid test date: 03Jan2021, covid test result: Positive; covid test date: 03Jan2021, covid test result: Positive; This is a spontaneous report from a contactable Other Health Professional (patient). A 37-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, lot # EJ1685) at single dose at left arm on 02Jan2021 11:45 for covid-19 immunisation. Medical history included post-traumatic stress disorder (PTSD), anxiety. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has received no other vaccines within 4 weeks prior to the COVID vaccine. On 03Jan2021 the patient has been tested for COVID-19 with rapid nasal swab test resulted positive. It was unknown if treatment was received. The outcome of events was unknown. Later the patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EL0140) at single dose at left arm on 23Jan2021 for covid-19 immunisation, administered at Pharmacy or drug store. The patient's concomitant medications in 2 weeks of this vaccination included: Lamictal, Klonopin, multivitamins, D, C, B, Zinc. On 24Jan2021 12:00 AM the patient experienced extreme tiredness, chills, fever, muscle aches, runny nose, sore throat, nausea, pale skin, malaise, night sweats. No treatment received for the adverse events. The outcome of events was recovering.; Sender's Comments: No effect of the suspect vaccine BNT162B2 could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.
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| 37 | 2021-02-10 | dizziness, fever, chills, headache |
dizziness; headache; tachycardia; chest pain; chills; fever; This is a spontaneous report from a con...
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dizziness; headache; tachycardia; chest pain; chills; fever; This is a spontaneous report from a contactable other healthcare professional (HCP). A 37-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982 and expiration date: unknown), intramuscular (right arm) on 24Jan2021 at 10:30 at a single dose for COVID-19 immunization. Medical history was not reported. Allergies to medications, food, or other products was unknown. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: unknown), on 03Jan2021 at 10:15AM, intramuscular (left arm) for COVID-19 immunization. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced dizziness, headache, tachycardia, chest pain, chills and fever on 25Jan2021. Treatment for the events included IV fluids, Benadryl, Antivert, Benadryl, Toradol and Reglan. The events required Emergency Room Visits and Physician Office Visit. The events were resolving at the time of the report.
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| 37 | 2021-02-21 | chills, shortness of breath, headache, fever, influenza like illness |
After my second dose of the vaccine I had typical flu-like symptoms (fever 101.5, chills/shivering, ...
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After my second dose of the vaccine I had typical flu-like symptoms (fever 101.5, chills/shivering, body pain, headache, nausea) yet also developed acute and severe shortness of breath. My flu-like symptoms resolved within 48 hours yet my breathing difficulties continued and worsened. I was treated in the Emergency Department on 1/12, 1/19 and 1/20 (work up negative for covid, pulmonary embolism, infection, cardiac abnormalities). It feels as though I am having intractable diaphragm spasms that are forcing my exhales out at the end of my breath cycle. I have lost 10lbs and have been essentially incapacitated for 6 weeks. I have been evaluated by head and neck (no vocal cord dysfunction), speech pathology (no swallowing difficulties), pulmonology (no lung specific issues) and am awaiting a neurology consult.
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| 37 | 2021-02-21 | skin warm |
Arm with large area of redness, warmth and induration. Started 2-3 days after injection and lasted ...
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Arm with large area of redness, warmth and induration. Started 2-3 days after injection and lasted until day 7
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| 37 | 2021-02-21 | pneumonia | Patient was admitted for community-acquired pneumonia |
| 37 | 2021-02-21 | throat irritation |
Patient was observed for 30 minutes following her vaccine and then was dismissed of, symptom free. S...
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Patient was observed for 30 minutes following her vaccine and then was dismissed of, symptom free. She then returned after 12 minutes complaining of feeling hot and flushed and throat, face and arms itching. Her O2 sat was 99% on room air, heart rate 71, respiratory rate of 18. She was given Benadryl 50 mg PO and after 10 or 15 minutes stated she did not have any of noted symptoms any longer.
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| 37 | 2021-02-21 | fatigue, influenza like illness, weakness, discomfort |
Pregnancy EDD 5/22. Approximately 21 weeks at time of vaccination. Had flu-like symptoms that starte...
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Pregnancy EDD 5/22. Approximately 21 weeks at time of vaccination. Had flu-like symptoms that started approximately 12 hours after vaccine. I felt weak, achy and tired. Symptoms resolved around 36 hours after vaccine.
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| 37 | 2021-02-21 | sweating, fatigue, fever, chills | Reported Fever 103F, fatigue, chills, sweats, and muscle aches. |
| 37 | 2021-02-22 | dizziness |
0843: POST VAC. ADMIN. C/O: DIZZINESS, NAUSEATED, SLUGGISH FEELING. VS: 98.3, P: 78, R: 18; BP...
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0843: POST VAC. ADMIN. C/O: DIZZINESS, NAUSEATED, SLUGGISH FEELING. VS: 98.3, P: 78, R: 18; BP: 128/70. ESCORTED, AMB. TO EHS.
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| 37 | 2021-02-22 | chills, fever, fatigue |
1/7 I started having breast pain. 1/8 I had a fever and chills, breast redness and diagnosed with Ma...
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1/7 I started having breast pain. 1/8 I had a fever and chills, breast redness and diagnosed with Mastitis in my right breast. I had severe fatigue and was prescribed a 7 day antibiotics and within 3-4 days I begin to feel back to normal. On 1/8 I had a COVID test which was negative. My breast milk supply went down on the right breast until the mastitis was resolved.
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| 37 | 2021-02-22 | headache | Flushing and headache |
| 37 | 2021-02-22 | fever | Low grade fever for 4 days, relieved by Tylenol. |
| 37 | 2021-02-22 | fatigue, fever, headache | Low grade temp. Body aches, head ache, and fatigue |
| 37 | 2021-02-22 | fatigue, headache, chills |
On 2/15 I begin to have chill, body aches, headache, fatigue and breast pains which continued into t...
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On 2/15 I begin to have chill, body aches, headache, fatigue and breast pains which continued into the next day. I was again prescribed the same 7 day antibiotic and disagnosed again with Mastitis but this time the symptoms lasted a little longer and after about day 5 I began to feel myself again. A mammogram and an ultrasound has been ordered to see why I developed the Mastitis so frequently but is not scheduled for another few weeks out from today.
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| 37 | 2021-02-22 | sweating |
Patient reported at 6:40 pm that she had thrown up and was having nausea. EMS attendant was on stan...
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Patient reported at 6:40 pm that she had thrown up and was having nausea. EMS attendant was on standby and took vitals: 129/89 BP, Resp 16, lungs clear on auscultation, pulse 104, blood sugar 69. Patient reported she had not eaten since 12:00 pm. Patient reported at 6:50 pm that her nausea was improving. At 7:00 pm, patient had a near-syncope event and was diaphoretic. She was placed in a wheelchair and taken to a private area. She appeared struggling to focus, but was responsive to questions. She developed a rash on her chest and an ambulance was called related to dermal, CNS, and GI symptoms. On ambulance arrival, Diphenydramine 15 mg IV was given and patient was transported to ER.
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| 37 | 2021-02-22 | sweating |
Pt was here for 1st dose of COVID vaccine. Had received vaccine approx. ten minutes before incident....
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Pt was here for 1st dose of COVID vaccine. Had received vaccine approx. ten minutes before incident. Pt noted to be slumped in chair, hives noted to forehead, diaphoretic, arms rigid, non-responsive to stimuli, Incontinent of bladder. Pt lowered to ground Zoll applied, COR called. Vital signs: 108/58 100% RA 77 26. Pt given EPI-Pen @ approx. 1352. COR Team arrived, pt mildly responsive. Assisted to Backboard and sent to ER with ED Provider. Pt was monitored in the ED for 3 hours with no recurrent symptoms. Pt advised to follow up with PCP and an allergist and avoid getting the 2nd dose of the covid vaccine.
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| 37 | 2021-02-25 | headache, shortness of breath, fatigue, chills |
tiredness; chills; headache; achiness of joints; congestion(hard to breathe); This is a spontaneous ...
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tiredness; chills; headache; achiness of joints; congestion(hard to breathe); This is a spontaneous report from a contactable consumer (patient). A 37-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot # EL-3247, in Workplace clinic, via an unspecified route of administration on 11Feb2021 at 23:30 (at 37 years of age) at single dose in left arm for COVID-19 immunization. The patient's medical history was not reported. The patient didn't receive any concomitant medication. The patient was not pregnant at the time of vaccination. She had received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot # EL-3247, via an unspecified route of administration on 21Jan2021 at 23:30 (at 37 years of age) at single dose in left arm for COVID-19 immunization. She was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 11Feb2021 at 20:00 (to be clarified) the patient experienced tiredness, chills, headache, achiness of joints and congestion (hard to breathe). The patient didn't receive any treatment. The reported events were resolving at the time of the report.
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| 37 | 2021-02-28 | weakness, fever, fatigue, dehydration, chills |
2nd dose: Fever; extreme chills; all over muscle aches; loss of taste; extreme fatigue; upset stomac...
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2nd dose: Fever; extreme chills; all over muscle aches; loss of taste; extreme fatigue; upset stomach; dehydrated; weakness; loss of appetite; chest tightness; feel like a panic attack; This is a spontaneous report from a contactable Other Healthcare Professional, the patient. A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), intramuscularly on 19Jan2021 at 11:00 (at the age of 37-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history was not provided. The patient has no allergies to medications, food, or other products. Historical vaccinations include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686) on 30Dec2020 at 19:00 intramuscularly as a single dose in the right arm for COVID-19 vaccination after which the patient experienced fatigue, muscle soreness in neck and shoulders and vaccination site pain. The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MIDOL) and ibuprofen(MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 19Jan2021 at 23:30 she began to experience fever, extreme chills, all over muscle aches, loss of taste for a day ,extreme fatigue, upset stomach, dehydrated, weakness, loss of appetite, chest tightness that would come and go making it feel almost feel like a panic attack. She further stated that she has lingering side effects such as extreme fatigue, muscle aches and chest tightness after day three of receiving this second dose that comes and goes. Currently on day seven and still have those lingering three side effects. Fatigue has been extreme at times. The patient did not receive any treatment for the events. The clinical outcomes of the events Fever, extreme chills, myalgia, loss of taste, extreme fatigue, upset stomach, dehydration, weakness, loss of appetite, chest tightness and panic attack were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107223 Same reporter, Same product, Same patient, same and different events (First Dose)
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| 37 | 2021-02-28 | fever, migraine |
HSV 1 eruption and subli; withdrawal bleeding 3 days late and heavier and longer than usual; migrain...
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HSV 1 eruption and subli; withdrawal bleeding 3 days late and heavier and longer than usual; migraine; Left index finger petechiae; had an insect bite; lymphadenopathy on the left deltopectoral (1x1 cm tender freely mobile) and on the left supraclavicular (2x1 cm tender freely mobile); temperature was 101 F; Acne flare-up; no withdrawal bleeding and she was on oral contraceptive pill (OCP)/withdrawal bleeding 3 days late; woke up at 2:00 AM and 2:35 AM because of the tenderness rolling over and she had to take central analgesia to be able to sleep; puffy face; tenderness at the site of injection; Constipation; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on the left arm, on 06Jan2021 15:45, at single dose, for covid-19 immunization. The patient has no medical history; unknown if there were any allergies. Concomitant medications included oral contraceptive pill (OCP) and multivitamins. The patient had no Covid prior to vaccination. She did not receive any other vaccines within 4 weeks prior to the Covid vaccine. She took pre-vaccination analgesia. The vaccine was given at the hospital. On 06Jan2021 (day 0) she experienced tenderness at the site of injection. She also experienced constipation on 06Jan2021. However, she couldn't "comment" about temperature since she was taking NSAIDs. She woke up at 2:00 AM and 2:35 AM on 07Jan2021 (day 1) because of the tenderness rolling over and she had to take central analgesia to be able to sleep. On 07Jan2021 she experienced tenderness at the site of injection and; puffy face but it wasn't angioedema. Her O2% was "99-98% repositioning" on 07Jan2021. She still had constipation and still couldn't comment about temperature since she was taking NSAIDs. On 08Jan2021 (day 2) she had an acne flare-up; and no withdrawal bleeding and she was on oral contraceptive pill (OCP). For the constipation she started on OTC fiber gum. On 09Jan2021 (day 4) she experienced lymphadenopathy on the left deltopectoral (1x1 cm tender freely mobile) and on the left supraclavicular (2x1 cm tender freely mobile) which hadn't resolved. She still was experiencing constipation. Her temperature was 101 F on 09Jan2021. On 10Jan2021 (day 5) she had withdrawal bleeding 3 days late and heavier and longer than usual, migraine, constipation, and left index finger petechiae because on "23/11" she had an insect bite on 10Jan2021. On 11Jan2021 (day 6) her lymphadenopathy on the left posterior cervical (1x1 cm tender freely mobile) hasn't resolved; she still had migraine and was now back to regular bowel habit. On 15Jan2021 (day 10) she had HSV 1 "eruption and subli". She received treatment (also reported as symptomatic treatment) for all these adverse events. At the time of the report, she recovered from constipation on 11Jan2021 with lasting effects; while she also recovered from all the other remaining adverse events on Jan2021 with lasting effects. She has not been Covid-tested post-vaccination.
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| 37 | 2021-02-28 | fatigue |
Soreness in arm extending beyond injection site; Soreness in arm extending beyond injection site; Fa...
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Soreness in arm extending beyond injection site; Soreness in arm extending beyond injection site; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) via an unspecified route of administration on 28Dec2020 (at the age of 37-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hepatitis C. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included buprenorphine, naloxone (SUBOXONE); bupropion (WELLBUTRIN); meloxicam; and lamotrigine (LAMICTAL); all from unknown dates for unspecified indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have allergies to medications, food, or other products. On 28Dec2020 the patient experienced soreness in arm extending beyond the injection site and fatigue for 2 days. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 tests on 28Dec2020, 30Dec2020, 04Jan2021, 08Jan2021, 11Jan2021, 14Jan2021, 19Jan2021, 25Jan2021 with results of negative. The patient did not receive treatment for the events. The events did not cause hospitalization. The outcome of soreness in arm extending beyond injection site was not recovered. The outcome of fatigue was recovered. No follow-up attempts are needed. No further information is expected.
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| 37 | 2021-02-28 | lethargy, headache |
soreness at injection site; lethargy after the vaccine; headache; This is a spontaneous report from ...
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soreness at injection site; lethargy after the vaccine; headache; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jan2021 at 13:30 at a single dose on the left arm for COVID-19 immunization. Medical history was reported as none. Concomitant medication included loratadine (CLARITIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 at 16:00, the patient experienced soreness at injection site, lethargy after the vaccine, and headache. The patient received ibuprofen as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 37 | 2021-03-02 | shortness of breath |
5 minutes after receiving the COVID-19 Vaccine shot, she had generalized itching allover her body; H...
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5 minutes after receiving the COVID-19 Vaccine shot, she had generalized itching allover her body; Her heart rate was in the 140s/tachycardia; She noticed the COVID-19 Vaccine injection site had a red welt; She developed a rash on her torso first, and then she developed a rash on her neck and face; Shortness of breath; Allergic reaction; Injection site rash; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL8982, expiry: unknown), via an unspecified route of administration in the left arm on 29Jan2021 14:25 at a single dose for COVID-19 immunization at a hospital. Medical history included asthma from 2001. The patient also had history of anaphylactic reactions to bee stings and strawberries. She said her allergist tested her further and told her she has severe allergies to tomatoes and to not eat tomatoes anymore. She said she has allergies to sulfa antibiotics. She said about 10 years ago was the last time she took a sulfa antibiotic and she had hives. She said her allergist recommended she avoid sulfa antibiotics. Concomitant medication included salbutamol sulfate (PROAIR HFA; lot: DAE36A, expiry: May2021; NDC Number: 59310-5779-22) from 2001 and ongoing for asthma. The patient has no prior vaccinations within 4 weeks. The patient received her first COVID-19 vaccine shot on Friday, 29Jan2021, and had an allergic reaction (Jan2021). 5 minutes after receiving the COVID-19 vaccine shot (29Jan2021 14:30), she had generalized itching all over her body, she then had tachycardia. She was administered some medication by the staff at the site where the COVID-19 vaccine was being administered, but her allergic reaction kept progressing. She developed a rash on her torso first, and then she developed a rash on her neck and face. She then developed shortness of breath. She was brought to the hospital's Emergency Room for further treatment. She was given the oral medications Pepcid 40mg, Claritin (dose unknown), and Benadryl 25mg at the location where the COVID-19 vaccines were being administered. When she started to experience shortness of breath, she used her own personal Albuterol inhaler. When she was in the Emergency Room, she was given a shot of Epinephrine .4ml at 15:16, and a dose of Benadryl 25mg IV at 15:10. She was observed in the Emergency Room for a couple of hours and then discharged. The patient was also given a steroid dose pack for her itching, clarified as Medrol 4mg tablets. She said she is titrating down the amount of Medrol 4mg tablets (NDC Number: 59762-4440-2, Lot Number: DM4008, Expiration Date: Oct2022). The patient reported that her itching has improved, but she still has a rash on her torso. She noticed the COVID-19 vaccine injection site had a red welt first on 29Jan2021, clarifying the vaccine injection site has a rash now (2021). She said she was put on a heart monitor when her allergic reaction began to progress, and her heart rate was in the 140s, clarifying she has a heart rate of 145. She said at the time she was discharged from the Emergency Room; her heart rate was 115. She stated she has had to use her Albuterol inhaler throughout the weekend, which is more so than usual, but it is currently allergy season where she lives in. She had no blood work performed while she was being treated in the Emergency Room but did have an EKG to be on the safe side, along with monitoring of her vital signs. The outcome of the events generalized itching, rash, and shortness of breath was recovering; event tachycardia was recovered on 29Jan2021; event vaccination site rash was not recovered while the other events was unknown.
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| 37 | 2021-03-02 | shortness of breath, influenza like illness |
acute and severe shortness of breath; typical flu-like symptoms (fever 101.5, chills/shivering, body...
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acute and severe shortness of breath; typical flu-like symptoms (fever 101.5, chills/shivering, body pain, headache, nausea); lost 10lbs; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the left arm on 08Jan2021, at 08:30 as the second single dose for COVID-19 immunization. Medical history included past history of migraines and colitis from unknown dates. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced allergy; the patient also has a vaccination history of BNT162B2 (lot number: EJ1685) as first dose on 18Dec2020 for COVID-19 immunization. On 08Jan2021, at 20:00, the patient experienced acute and severe shortness of breath, typical flu-like symptoms (elaborated as fever 101.5, chills/shivering, body pain, headache, nausea), and lost 10lbs. The events were reported as life-threatening, elaborated by the reporting nurse as have been "essentially incapacitated for six weeks". The patient underwent lab tests and procedures which included body temperature: 101.5 on 08Jan2021, Nasal Swab: negative on 12Jan2021, weight: lost 10lbs on an unspecified date. Clinical course was as follows: patient noted that it felt as though she was having intractable diaphragm spasms that were forcing her exhales out at the end of her breath cycle. She lost 10lbs and was essentially incapacitated for 6 six weeks. The patient has been evaluated by head and neck , with no noted vocal cord dysfunction, speech pathology (no swallowing difficulties were noted), pulmonology (no lung specific issues were noted) and was awaiting a neurology consult. Therapeutic measures were taken as a result of the events, and included unspecified treatments in the emergency department described as lots of medications. There was no COVID infection prior to vaccination, and the patient has been tested post the vaccination, with negative results as aforementioned. The clinical outcome of typical flu-like symptoms (fever 101.5, chills/shivering, body pain, headache, nausea) was recovered in Jan2021; the clinical outcome of acute and severe shortness of breath and lost 10lbs was not recovered.; Sender's Comments: Based on event-vaccine chronological association, a causal relationship between events severe shortness of breath and typical flu-like symptoms and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded. the event lost weight is attributed to an intercurrent medical condition and assessed unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 37 | 2021-03-03 | throat swelling |
Fullness/swollen sensation of throat with mild lymphadenopathy; Fullness/swollen sensation of throat...
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Fullness/swollen sensation of throat with mild lymphadenopathy; Fullness/swollen sensation of throat with mild lymphadenopathy; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3249), via an unspecified route of administration in Jan2021 as first single dose for COVID-19 immunization. Medical history included COVID prior to vaccination from an unknown date. No known allergies were noted. The patient's concomitant medications were not reported. The patient experienced fullness/swollen sensation of throat with mild lymphadenopathy in Jan2021 with outcome of recovered on an unspecified date in 2021. The patient underwent lab tests and procedures which included blood test/ antibody positive in May2020 and Nasal Swab/ PCR negative in Nov2020. There were no treatments given for the events. The clinical outcome of events was recovered on an unspecified date in 2021.
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| 37 | 2021-03-07 | fatigue, shortness of breath |
01/29/2021 Fatigue, soreness at injection site. Pt took OTC Tylenol/Advil. 02/18/2021 Epigastric pai...
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01/29/2021 Fatigue, soreness at injection site. Pt took OTC Tylenol/Advil. 02/18/2021 Epigastric pain, dyspnea, nausea, vomiting. Pt took OTC Tylenol/Advil and went to Dr. office because pt thought she had gallbladder pain/concern. 02/20/2021 Pt went to ED: tested negative for Covid-19 virus but found to have elevated liver enzymes. Pt remained at hospital inpatient status until 02/24/2021. Pt states she was never given any diagnoses/causes for symptoms. 03/05/2021 Pt went to her PCP, and blood labs obtained; pt continues to have elevated liver enzymes per pt's report.
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| 37 | 2021-03-10 | migraine |
Aprox 3 min after injection, broke out in rash and hives, severe itching in neck, face, chest, tingl...
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Aprox 3 min after injection, broke out in rash and hives, severe itching in neck, face, chest, tingling lips and shaking. EMS was on scene at clinic immediately removed me from car and checked vitals, BP was high 176/94, took by ambulance to ER at Medical Center. Treated in ER for 4.5 hours. Developed migraine, received benadryl, steriods,and medicine for the migraine. Sent home told take benadryl for 2 days and do
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| 37 | 2021-03-14 | headache |
Joint pain in knuckles on fingers, knees, ankles, and wrists; slight headache; This is a spontaneous...
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Joint pain in knuckles on fingers, knees, ankles, and wrists; slight headache; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK4176), via an unspecified route of administration in the left arm, on 22Jan2021 at 13:45 (at the age of 37-years-old) at a single dose for COVID-19 immunisation. Medical history included asthma, high cholesterol, and allergies to mushrooms. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no concomitant medications taken within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced slight headache on 22Jan2021 at 21:00 and joint pain in knuckles on fingers, knees, ankles, and wrists on 29Jan2021. The events were reported as non-serious. The clinical course was reported as follows: The patient started to feel a slight headache a few hours after vaccination, which had gotten worse and at the time of reporting, it was week 3. The patient also experienced joint pain in knuckles on fingers, knees, ankles, and wrists. The joint pain started a week after vaccine administration. The patient never felt joint pain before until now. The patient did not receive any treatment for the events. The clinical outcome of slight headache and joint pain in knuckles on fingers, knees, ankles, and wrists was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 37 | 2021-03-17 | head discomfort, shortness of breath, fatigue, headache, somnolence, thirst, weakness |
*Pressure in the head *Pulling and warmth in the face *Tingling in the tongue, feet and fingers: Gab...
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*Pressure in the head *Pulling and warmth in the face *Tingling in the tongue, feet and fingers: Gabapentin *Extreme exhaustion and sleepiness *Body ache: Tylenol *Headache- Tylenol *Extreme thirst *Nausea: Ondansetron *Vomiting *Constipation: Senna with Docusate Sodium *Weakness *Some difficulty breathing
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| 37 | 2021-03-18 | shortness of breath |
After waiting 15 minutes I was walking to my car and felt short of breath. Then I felt like my throa...
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After waiting 15 minutes I was walking to my car and felt short of breath. Then I felt like my throat was tight and I couldn't swallow.; After waiting 15 minutes I was walking to my car and felt short of breath. Then I felt like my throat was tight and I couldn't swallow.; After waiting 15 minutes I was walking to my car and felt short of breath. Then I felt like my throat was tight and I couldn't swallow.; This is a spontaneous report from a contactable nurse. This 37-year-old female nurse reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN9581), into the right arm on 08Feb2021 at 11:30 AM at single dose for COVID-19 immunization. Medical history included hypothyroidism, gerd, depression, pcos. The patient had known allergies to sulpha and Ceclor. Concomitant drugs were unknown. The nurse reported that she received vaccine on 08Feb2021, after waiting 15 minutes she was walking to her car and felt short of breath. Then she felt like her throat was tight and she couldn't swallow. The patient visited Emergency room/department or urgent care and was hospitalized. She was treated with Epinephrine x 3, Benadryl, steroids, famotidine. The outcome of the events was resolved with sequelae.; Sender's Comments: Based on available information, a contributory role of BNT162B2 vaccine can not be excluded for the reported events of short of breath, throat tight and swallow difficulty due to temporal relationship and current known drug safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 37 | 2021-03-21 | shortness of breath | 1 mins s/p vaccination had a panic attack. increased HR, SOB and anxiety |
| 37 | 2021-03-21 | headache |
pain is severe and disabling; severe myalgia to legs started next day after 2nd dose, then to should...
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pain is severe and disabling; severe myalgia to legs started next day after 2nd dose, then to shoulders, arms, with mild headache. Never resolved after 2 weeks. gabapentin gave temporary relief but pain is severe and disabling.; mild headache; This is a spontaneous report. A contactable physician reported that a 37-year-old non-pregnant female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6205), first dose via intramuscular on 06Feb2021 as single dose for COVID-19 immunization, received (BNT162B2, solution for injection, Batch/Lot Number: EM9810) second dose via intramuscular on 27Feb2021 as single dose for COVID-19 immunization and patient was non-pregnant at the time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included endometriosis, and patient had allergy for meloxicam, NSAIDs, blepharospasm and angioedema. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Concomitant medication included norethindrone acetate (NORETHINDRONE ACETATE) taken for an unspecified indication, botulinum toxin nos (BOTULINUM TOXIN NOS) taken for an unspecified indication on 08Jan2021 to an unspecified stop date. The patient experienced pain was severe and disabling, severe myalgia to legs started next day after the second dose, then to shoulders, arms, with mild headache on 28Feb2021. Never resolved after 2 weeks. Therapeutic measures were taken as a result of pain is severe and disabling (pain), severe myalgia to legs started next day after second dose, then to shoulders, arms, with mild headache. never resolved after 2 weeks and gabapentin gave temporary relief, but pain is severe and disabling. (myalgia), mild headache (headache). The outcomes of the events was not recovered. Follow-up information has been requested.
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| 37 | 2021-03-22 | chills, dizziness |
Dizziness; Chills; Everything I eat and drink tastes like chemicals/I tried other peoples food items...
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Dizziness; Chills; Everything I eat and drink tastes like chemicals/I tried other peoples food items as well they all tasted, off; This is a spontaneous report from a contactable Other HCP. A 37-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9264), via an unspecified route of administration single dose left arm on 10Feb2021 07:30 for covid-19 immunisation. The patient received the first dose (Lot # EL3249) left arm on 20Jan2021 07:30 AM. Medical history included type 2 diabetes mellitus. Concomitant medication included metformin, insulin glargine (LANTUS). The patient experienced dizziness on 10Feb2021 20:00, chills on 10Feb2021 20:00, everything I eat and drink tastes like chemicals/i tried other people food items as well they all tasted, off (ageusia) on 10Feb2021 20:00. The events outcome was not recovered.
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| 37 | 2021-03-22 | dizziness, fatigue, chills, migraine, shortness of breath, fever |
Hives, fever, chills, body aches, migraines, vertigo, photosensitivity, phonophobia, nausea, fatigue...
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Hives, fever, chills, body aches, migraines, vertigo, photosensitivity, phonophobia, nausea, fatigue, dizzy light-headed, loss of voice, sob, diarrhea, and sore arm. No outcome still ongoing testing and seeing specialists.
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| 38 | 2020-12-31 | chills |
Chills, started 8:30 ish in the morning after I woke up today and lasted for half an hour. Second ti...
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Chills, started 8:30 ish in the morning after I woke up today and lasted for half an hour. Second time I had severe chills around 1:45 pm in the afternoon. And My right arm has soreness.
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| 38 | 2021-01-02 | throat swelling, shortness of breath | Patient had shortness of breath, slight throat swelling, arm swelling, and increased heart rate |
| 38 | 2021-01-03 | throat swelling, chills |
Allergic reaction; Diarrhea; Chills; Palpitation; Tongue and throat swelling; Tongue and throat swel...
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Allergic reaction; Diarrhea; Chills; Palpitation; Tongue and throat swelling; Tongue and throat swelling; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELO141), via an unspecified route of administration on 21Dec2020 at a single dose for covid-19 immunization. The patient's medical history included asthma and allergy. Concomitant medication included levosalbutamol hydrochloride (XOPENEX) for asthma and cetirizine hydrochloride (ZYRTEC) for allergy. About hour and a half to two hours after the vaccine, on 21Dec2020, the patient experienced had an allergic reaction with symptoms set of diarrhea, chills, palpitations, and tongue and throat swelling. The patient took diphenhydramine (BENADRYL) 25 mg as treatment. It helped some. She woke up this morning (22Dec2020) and still had the symptoms. So, she went to the emergency room. They gave her diphenhydramine 25 mg IV, methylprednisolone (SOLUMEDROL), and famotidine (PEPCID). The patient underwent lab tests and procedures which included blood count and chemistry and lab work which showed normal on 22Dec2020. Outcome of the events was unknown. The patient thinks that the product had causality to the events. Information on the lot/batch number has been requested.; Sender's Comments: The patient's medical history included asthma and allergy. Based on information available, the reported allergic reaction with symptoms set of diarrhea, chills, palpitations, and tongue and throat swelling was likely related to the use of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 38 | 2021-01-03 | malaise, shortness of breath, fatigue, discomfort, headache, cough, respiratory tract congestion, fever |
Have a fever with a high of 99.6 Fahrenheit; felt winded like she has exerted herself more than expe...
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Have a fever with a high of 99.6 Fahrenheit; felt winded like she has exerted herself more than expected/shortness of air; Coughing/cough got worse; She is covid positive/Tested positive for COVID 19; She is covid positive/Tested positive for COVID 19; Shortness of breath/Shortness of breath was reported as worsened/feels winded; Tachycardia; Has been sick ever since; Felt like she was in a fog, on a cloud, heavy and out of it; She felt hot and weird but had no fever; Headache; Burning sensations in her legs; Extreme fatigue, want to go to bed; headache went away and she felt like the congestion was clearing up some; Arm was sore; This is a spontaneous report from a contactable ICU nurse (patient [Registered nurse ADN]) via Pfizer-sponsored program. A 38-year-old female patient received single dose of BNT162B2 (lot number: EK5730) , via an unspecified route of administration (right arm) on 16Dec2020 20:30 for immunization (for front line health care worker). Medical history included allergies; acid reflux; patent foramen ovale (PFO); supraventricular tachycardia (SVT) without treatment, vitamin D low and ongoing smoker. The patient had no other history/family history. Concomitant medication included loratadine (CLARITIN) taken for at least 5 years for allergy, famotidine from Dec2020 for acid reflex, and vitamin D taken for 5 or more years for vitamin D low; all given orally and were ongoing. The patient had no other prior vaccines within 4 weeks of Covid vaccination. Patient had been taking Covid tests on and off due to her immunocompromised daughter. On 15Dec2020 she took the PTR that took three to four days for results; she tested negative for Covid and was completely asymptomatic. She then received the COVID 19 vaccine 16Dec2020. Her test was positive for COVID 19 on 18Dec2020 and she had been sick ever since. She received the vaccine at the hospital where she works. The vaccine was not administered at facility. She further reported she was fine after getting the COVID 19 vaccine. Her right arm was sore/ started to hurt about four or five hours later on 16Dec2020 but then was fully after 24 to 48 hours. She started to feel sick on 18Dec2020 (Friday evening). States she went to bed Friday morning after the night shift. She felt fine, better than normal. That same day (18Dec2020) she woke up at 1700 and felt like she was in a fog, on a cloud, heavy and out of it. She walked around for a while and that sensation didn't go away. She felt hot and weird but had no fever. Then at 1830 she got the alert on her phone that told her she was positive for COVID 19. She started to feel other symptoms on 18Dec2020 including headache, shortness of breath, tachycardia, burning sensations in her legs; extreme fatigue, wanting to go to bed that persisted from Friday to Sunday. Then on 20Dec2020, Sunday afternoon, her headache went away and she felt like the congestion was clearing up some. Mentions she did have a fever (onset date unspecified) with a high of 99.6 Fahrenheit; but it went back down to 99.0 Fahrenheit (date/s unspecified). On 20Dec2020 the patient experienced coughing. On 21Dec2020 (Monday) she started coughing more but states her O2 was fine and her breathing was okay. However, when walking around she felt winded like she has exerted herself more than expected. She then clarified that on 21Dec2020, she experienced shortness of air and the cough got worse but it has now plateaued. She did call her HCP and they were holding off on treatment at the time. No investigation assessment was performed. The patient was not admitted to an Intensive Care Unit. The patient did not display clinical signs at rest indicative of severe systemic illness nor did she require supplemental oxygen or receive mechanical ventilation. No preexisting diseases worsened during the SARS-CoV2 infection. The patient considered shortness of breath, and tachycardia as serious: medically significant while the events headache, burning sensations in her legs, fatigue, Coughing, and feels winded were considered as not serious. The events headache, shortness of breath, tachycardia, burning sensations in her legs, fatigue, Coughing, and feels winded were ongoing at the time of reporting. Shortness of breath worsened. The patient recovered from arm was sore on an unspecified date in Dec2020; and was recovering from tachycardia, sick, headache and congestion. The outcome of felt like she was in a fog, on a cloud, heavy and out of it; felt hot, and fever was unknown while not recovered for the other events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 38 | 2021-01-03 | fever, chills, headache, fatigue |
I began feeling tired around 2pm 24 hours after vaccination. I also had a head ache, fever and chill...
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I began feeling tired around 2pm 24 hours after vaccination. I also had a head ache, fever and chills around 3-4pm fever was low grade stayed around 99.8 the following day which was the 23 of dec i had a headache all day and felt fatigued on the 24 i felt normal. My arm was sore VERY sore for about 4 days. I did test positive for covid on 11/2/2020 with moderate symptoms
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| 38 | 2021-01-04 | throat irritation, runny nose, headache |
5 minutes after receiving vaccine: Itchy throat Mouth numb Runny nose 30 minutes Eyes watering He...
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5 minutes after receiving vaccine: Itchy throat Mouth numb Runny nose 30 minutes Eyes watering Headache
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| 38 | 2021-01-04 | shortness of breath |
Anaphylaxis Patient was vaccinated and within just a few minutes of vaccine administration began to ...
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Anaphylaxis Patient was vaccinated and within just a few minutes of vaccine administration began to feel throat tightening, difficultly getting air, tachycardia, and dry mouth. Admitted to a past history of anaphylaxis with shell fish and endorses similar symptoms. Employee was treated with an epi pen and taken to the emergency room for additional monitoring and treatment as needed
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| 38 | 2021-01-04 | fatigue, headache |
Headache; Hypertension; Face flushed; Extremely tired; Slow Motion; Slurred Speech; This is a sponta...
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Headache; Hypertension; Face flushed; Extremely tired; Slow Motion; Slurred Speech; This is a spontaneous report from a contactable healthcare professional. A 38-year-old female patient started to receive BNT162B2 (lot number: EJ1685), intramuscularly on 29Dec2020 08:00 at left arm at single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medications were not reported. Patient previously took metronidazole (FLAGYL) and experienced allergy. Patient experienced headache, hypertension, face flushed, extremely tired, slow motion, and slurred speech on 29Dec2020 09:30. Treatment was not received for these events. Outcome of the events was resolving.
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| 38 | 2021-01-04 | headache, fever, chills |
I felt fine initially just so soreness of my arm. The next day I started with the chills and a littl...
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I felt fine initially just so soreness of my arm. The next day I started with the chills and a little bit of the headache, I just kinda figured it was a response to the vaccine and did not think much of it. Through the night I had fever (100.8F), chills and headache. I took some Excedrin and Wednesday morning I felt ok. I decided to go to work but the screening told me because I had fever in less than 24 hrs I could not go to work I had to report to the COVID hotline. They sent me to get tested because of the fever. I got tested at hospital and was tired the rest of the day but no fever and the next day I was ready to go to work but I had to wait for the test results that would come 24hrs later. The test came back positive. So I could not return to work until yesterday.
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| 38 | 2021-01-04 | headache |
In first few days after vaccination experienced arm pain, headaches and body aches. All symptoms su...
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In first few days after vaccination experienced arm pain, headaches and body aches. All symptoms subsided by day 7. On day 10 (12.31) began to again experience arm pain and new rash over injection site. Pain spread to opposite arm and then became generalized. Pain worse in armpits. Rash turned into raised bullseye over injection site prompting MD visit. COVID tested completed and was negative blood work sent and is pending. I was started on Pepcid/benedrly and doxycycline.
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| 38 | 2021-01-04 | dizziness, fatigue |
It was extremely painful when I received the vaccine and I immediately felt my fingers tingling. In ...
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It was extremely painful when I received the vaccine and I immediately felt my fingers tingling. In about 10 min I felt very hot in my face, back and felt like I was going to pass out. My heart was racing, it was about 130. My BP initially was 139 and then 160 after that. I never passed out but I felt those waves with a tingling to my face and my neck as I was going to pass out and I started shaking and my heart was racing and my BP was up and it lasted about 45 min before it started going down. They gave me some Ibuprofen at the Employee health and they kept observing me and it started getting better after 45 min. I still felt the waves of feeling flush and hot and cold and very fatigued.
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| 38 | 2021-01-04 | chills, headache, fever, fatigue |
Mild headache starting on Saturday evening around 7:00pm, January 2nd, took 3 ibuprofen, Sunday morn...
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Mild headache starting on Saturday evening around 7:00pm, January 2nd, took 3 ibuprofen, Sunday morning, January 3rd, woke up around 10-11am body aches, headache, fatigue, swollen lymph node under left arm pit, took 3 ibuprofen around 12:00pm. Headache and body aches subsided slightly but never fully gone. Around 6:00pm -7:00 low grade fever and chills, took 3 ibuprofen around 8:00pm. Body aches and fatigue continued to Monday, January 4th, but was reduced in severity, took 3 ibuprofen around 10:00am. All symptoms with exception of swollen lymph node and heat/swelling/pain at injection site are now gone by Tuesday January 5th.
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| 38 | 2021-01-04 | dizziness | PTE PRESENTA MAREOS Y BP ELEVADA. POR LO QUE REQUIERE SER EVALUADA POR MD DE TURNO. |
| 38 | 2021-01-04 | chills, cough, dizziness, fever |
Received vaccine on 1/4/21 at 12:50. On 1/5/21 at 3:00 called nurse line to report fever of 101.8, ...
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Received vaccine on 1/4/21 at 12:50. On 1/5/21 at 3:00 called nurse line to report fever of 101.8, chills, cough, dizzy with standing.
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| 38 | 2021-01-04 | headache, throat pain | Sore throat Decreased taste Headache |
| 38 | 2021-01-04 | fatigue, headache |
Within first 5 mins - Sudden onset of warm sensation (similar to the feeling of IV contrast administ...
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Within first 5 mins - Sudden onset of warm sensation (similar to the feeling of IV contrast administration), flushed feeling, pale, near syncope followed by nausea and dry heaving. Lasted 30 mins. Felt fatigued and mild headache for next 24-48 hours.
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| 38 | 2021-01-04 | fatigue, headache |
developed 2 more of the same type of sores on inside of my cheek, in mouth; sore under top lip; head...
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developed 2 more of the same type of sores on inside of my cheek, in mouth; sore under top lip; headache; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 12:00 PM, at left arm, at single dose for covid-19 immunization. Medical history included hepatitis c from an unknown date and unknown if ongoing. Concomitant medication included fluoxetine hydrochloride (PROZAC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient was not pregnant at the time of vaccination. First day on 24Dec2020 the patient had headache and fatigue, some nausea. Day 3 (26Dec2020) and 4 (27Dec2020) headaches all day, mild. Day 5 (28Dec2020) developed sore under top lip and day 6 (29Dec2020) developed 2 more of the same type of sores on inside of my cheek, in mouth. No treatment was received for all events. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information about lot/batch number has been requested.
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| 38 | 2021-01-04 | dizziness |
per pt. after covid vac. shot was given ,she fell palpitations and lightheadedness after few mins. ...
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per pt. after covid vac. shot was given ,she fell palpitations and lightheadedness after few mins. receiving the vac.
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| 38 | 2021-01-04 | fever, chills, fatigue, headache, sweating |
sweating; Fatigue; Fever; Headache; chills; This is a spontaneous report from a contactable consumer...
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sweating; Fatigue; Fever; Headache; chills; This is a spontaneous report from a contactable consumer. A 38-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number: EL1284, via an unspecified route of administration, in the left arm, on 29Dec2020 at around 17:15 (at the age of 38 years-old) as a single dose for COVID-19 immunization. Medical history included ongoing high blood pressure, diagnosed about 15 years ago. There were no concomitant medications. It was not known if the patient received any other vaccines within four weeks prior to the vaccination. On 30Dec2020, the patient experienced fatigue, fever, chills, headache and sweating. The clinical course was as follows: The patient reported that she started developing symptoms after having the COVID vaccine on 29Dec2020. On 30Dec2020, she was fatigued. The headache started earlier in the day. She did not have a thermometer on hand but she thought she had a fever and chills. She was wrapped up because she was so cold. She took 600mg of Ibuprofen around 13:30, which she thought broke her fever because she was sweating. She was still fatigued but not as bad as when she had a fever. The clinical outcome of the fever and chills was recovered, for the fatigue was recovering; the headache was not recovered; the outcome of the sweating was not reported. It was not known if she was tested for COVID-19 after the vaccination.
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| 38 | 2021-01-04 | throat irritation | urticaria generalized and involving soft palate |
| 38 | 2021-01-05 | throat irritation |
A couple minutes after injection I felt flush over my chest area. It lasted about 30 seconds then my...
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A couple minutes after injection I felt flush over my chest area. It lasted about 30 seconds then my heart started racing. My iwatch heartrate notified me that my heart rate was 162. This lasted for about 7 minutes. My throat felt a little scratchy but not to where I had anaphylaxis reaction to seafood.
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| 38 | 2021-01-05 | runny nose, sweating, nasal congestion, throat irritation |
About 1 minute after receiving the vaccine, I suddenly felt hot and sweaty. After about 20 minutes, ...
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About 1 minute after receiving the vaccine, I suddenly felt hot and sweaty. After about 20 minutes, I began experiencing mild itching on my face, chest and upper body (no hives or rash) and my face was flush. At about 40 minutes, began experiencing nasal congestion, runny nose and and a slight tickle in the back of my throat. A few hours later, all symptoms resolved.
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| 38 | 2021-01-05 | chills | Chills, shivering, body aches, joint aches , treated with Motrin with improved symtpoms |
| 38 | 2021-01-05 | fatigue | Extreme fatigue |
| 38 | 2021-01-05 | throat irritation | FELT WARM SCRATCHY THROAT. OBSERVED |
| 38 | 2021-01-05 | fatigue |
Fatigue and injection site soreness. Narrative: Patient awakened this AM with injection site sorene...
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Fatigue and injection site soreness. Narrative: Patient awakened this AM with injection site soreness and fatigue. She did not come to work today stating she felt too tired
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| 38 | 2021-01-05 | chills, shortness of breath |
Having trouble clearing my throat, felt like it was closing up; Having trouble clearing my throat, f...
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Having trouble clearing my throat, felt like it was closing up; Having trouble clearing my throat, felt like it was closing up; Uncontrollable rigors; High heart rate; Numb lips and hands; Numb lips and hands; Nausea; Shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A 38-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685, expiry date 30Dec2020) intramuscular (Arm Left), on 30Dec2020 09:15, single dose, for COVID-19 immunization. Relevant medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had gall bladder removed, and had tonsils removed. It was reported that the patient cannot take NSAIDS, patient was not allergic to them. No allergies to food or other products. Concomitant medications included rizatriptan and paracetamol (TYLENOL). On 30Dec2020, within about 10 minutes of the injection of the vaccine, the patient had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea. The patient was discharged from the ED, went home and took a nap. Later that evening, the patient began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath, and was admitted to the ED again and given more IV medications. Therapeutic measures given in response to the event included administration of IV medications, epinephrine injection and breathing treatment. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks, was not tested or diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events oropharyngeal discomfort, throat tightness, chills, heart rate increased, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 38 | 2021-01-05 | headache, fever |
Headache, Body aches, swollen eyes/face, dry scratchy feeling when breathing, low grade fever I call...
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Headache, Body aches, swollen eyes/face, dry scratchy feeling when breathing, low grade fever I called staff with pharmacy COVID Vaccination team and notified her of the adverse reaction. The employee was seen at the medical clinic by "staff", Dr, nurse practitioner. Employee was informed that these were all common side effects + she should go ahead and take the second vaccine when it's scheduled on 1/26/21
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| 38 | 2021-01-05 | dizziness |
I received my COVID-19 vaccine on 12/20/2020, all was fine despite a sore arm. Around the 48-hour ma...
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I received my COVID-19 vaccine on 12/20/2020, all was fine despite a sore arm. Around the 48-hour mark, I developed extreme dizziness and I received medical care at ER on the 23rd of December.
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| 38 | 2021-01-05 | fatigue |
I was 5.5 weeks pregnant when I revived the Pfizer Covid Vaccine. Everything was seemingly going fin...
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I was 5.5 weeks pregnant when I revived the Pfizer Covid Vaccine. Everything was seemingly going fine with my pregnancy until about 4 hours after receiving the vaccine when I went to the bathroom nd wiped and saw pink discharge on the toilet paper. I then began to have mild low abdominal cramping. The abdominal cramping and vaginal bleeding steadily increased in severity over the next 24 hours until I eventually had an obvious miscarriage the evening of 12/31/2020. I cant help but think the vaccine in some way caused my body to reject the pregnancy. Along with the miscarriage, I also had extreme tiredness with GI upset 12/31/20 - 1/02/2021.
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| 38 | 2021-01-05 | throat irritation | Itching in throat, Burning in chest |
| 38 | 2021-01-05 | migraine | Migraines, right side of face swollen, nausea, tingling |
| 38 | 2021-01-05 | headache |
Mild Headache; Flushing; Nausea Monitored for 35 mintes Symptoms resolved prior to being released t...
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Mild Headache; Flushing; Nausea Monitored for 35 mintes Symptoms resolved prior to being released to home.
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| 38 | 2021-01-05 | throat irritation |
Provider arrived for her Covid vaccine. After vaccine was administered she had an immediate localize...
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Provider arrived for her Covid vaccine. After vaccine was administered she had an immediate localized reaction of tenderness and slight redness. No other symptoms. Provider was placed in the observation area and given and ice pack for the area and made aware that we do have oral Benadryl available. After about 2-3 min Genoveva alerted me that she was now having some itching/scratchiness to the back of her throat and requested Benadryl. 25 mg PO with water was administered and she was immediately escorted to the ED for evaluation with an RN, per protocol.
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| 38 | 2021-01-05 | fever, headache, fatigue, shortness of breath, chills |
Shortness of breath; Sore arm like she got kicked in the arm by a horse. Her arm felt like this toda...
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Shortness of breath; Sore arm like she got kicked in the arm by a horse. Her arm felt like this today.; Chest pain; Headache; Body aches; Fever; Chills; fatigued; feels cold; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (lot number: EL3246), via an unspecified route of administration, at deltoid right, on 30Dec2020 07:45, at single dose, for COVID-19 immunization. Medical history included chronic asthma from an unspecified date, stomach surgery a year and a half ago, sometimes has stomach pain that feels like chest pain since her stomach has been surgically altered. Has had asthma stuff since she was very young. Is relatively healthy. No family medical history. No relevant tests. The patient's concomitant medications were not reported. No additional vaccines administered on same date of Pfizer suspect. No prior vaccinations within 4 weeks. The patient previously took flu vaccine on 01Oct2020 and experienced fatigued, tired, and sore arm like she got kicked in the arm by a horse. It was reported that received COVID-19 vaccine yesterday (30Dec2020). Been having some chest pain. Started a couple hours after receiving the COVID-19 Vaccine. Chest pain doesn't whole heartedly go away. Gets more intense and then relaxes. Wants to know if this is common or something she just has to deal with. Doesn't know if this is stomach pain. Had stomach surgery a year and a half ago. Sometimes has stomach pain that feels like chest pain since her stomach has been surgically altered. Has been taking heartburn and gas medications. Chest pain is not going away. Wants to know if this is common. Tried to look online and only found common side effects. Her husband looked it up and two people died from a heart attach after receiving the COVID-19 Vaccine. She is getting older, but is not that old. Caller works in behavioral health. Had an instant headache. Clarified chest pain: Is always lingering in the background. Doesn't fully go away. Comes and goes in waves. Gets intense and relaxes. Chest pain was pretty sharp this morning and it made her short of breath. Doesn't know if it was the pain that took her breath away. Occurred at 10:00. Indication: Has older people she takes care of. Her mother is super frail and has dementia. Her uncle is elderly and has heart issues. Wants to do her part so she doesn't catch it. No further details provided. In regards to the two people who had heart attacks and died after COVID-19 Vaccine, caller has no patient identifiers or NDC/Lot/Exp to provide. Stated this people were in the UK and the information was just something her husband read on the internet. Also experienced body aches, fever, and chills between 14:30 and 15:00 yesterday, 30Dec2020. Is super fatigued. Doesn't know if she is febrile, hasn't checked temperature. Still feels cold and has chills today. Does not have a headache today. It was also reported that fatigued and tired with Flu Vaccine (historical vaccine). Sore arm like she got kicked in the arm by a horse. Her arm felt like this today (31Dec2020). Therapeutic measures in response to chest pain is received, treatment included heartburn and gas medications. Gas medication is Equate brand Simethicone Extra Strength Gas Relief (NDC: 49035-487-02, Lot:H22016, Exp: Sep2022) at 125mg liquid-gel. Heartburn medication is Equate brand Cimetidine 200mg tablet (NDC: 49035-820-72, Lot: Doesn't know if lot number is OJE2445C or 0JE2445C, Exp: Jun 2022). Stated writing is so tiny. Gas and heartburn medication has not helped with chest pain. The outcome of the event chest pain was not recovered, of the other events were unknown.
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| 38 | 2021-01-05 | runny nose, chills, headache, influenza like illness, fever, cough |
Symptoms began around 6pm and gradually worsened? sneezing, runny nose, cough, sinus congestion, fev...
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Symptoms began around 6pm and gradually worsened? sneezing, runny nose, cough, sinus congestion, fever/chills, body aches (arthralgias, myalgia), headache, site injection pain (which was immediate upon injection, I bled- not a good administration), polyuria/difficulty sleeping overnight, I felt like I was very sick with the flu.
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| 38 | 2021-01-05 | fatigue, chills | Whole body aches, chills, fatigue |
| 38 | 2021-01-05 | fever, sweating, chills |
Woke up with sore left arm and some redness and swelling at injection site on 1.5.21. Chills and ge...
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Woke up with sore left arm and some redness and swelling at injection site on 1.5.21. Chills and generalized body aches began about 1230, temperature taken at that time was 99.0. Continued with work and by 1530 began to have increased myalgias and pain in knees, took temperature 100.0 and took 400mg Ibuprofen. Fever broke, began to have diaphoresis and felt body aches were gone with exception to left arm. Woke up 1.6.21 and with pain in left axilla and noted to have tender and swollen lymphnodes. Took another 400mg Ibuprofen about 0830. Muscle pains remain to arm, axilla and neck.
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| 38 | 2021-01-05 | fatigue, dizziness | dizziness, fatigue, arm soreness, myalgia |
| 38 | 2021-01-06 | headache, chills, fever |
AT APPROXIMATELY 5PM ON DAY OF VACCINATION, DEVELOPED SORENESS IN LEFT ARM. AROUND 10PM SHE EXPERIEN...
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AT APPROXIMATELY 5PM ON DAY OF VACCINATION, DEVELOPED SORENESS IN LEFT ARM. AROUND 10PM SHE EXPERIENCED EXTREME PAIN, COULDN'T LIFT HER ARM OR MOVE THE FINGERS ON THAT ARM. IT ADVANCED TO HER NECK AND BACK, SEVERE HEADACHE, STATING IT FELT LIKE SHE HAD BEEN HIT IN THE HEAD WITH A HAMMER. SHE ALSO FELT HEART POUNDING AND HAD CHEST PAIN. DESCRIBES ALL THE PAIN AS THROBBING. SHE RAN FEVERS (HIGHEST WAS 100.3) AND HAD CHILLS. DIDN'T GET OUT OF BED UNTIL 11:30 THE FOLLOWING MORNING.
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| 38 | 2021-01-06 | nasopharyngitis |
FEELING FLUSHED, MILD FACIAL FLUSHING Narrative: 0825 C/O FEELING HOT , MILD FACIAL FLUSHING 120/84...
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FEELING FLUSHED, MILD FACIAL FLUSHING Narrative: 0825 C/O FEELING HOT , MILD FACIAL FLUSHING 120/84 P101 99% RA R 18 0837: 50MG BENADRYL GIVEN IM, 0841: C/O DRY MOUTH, FEELING SHAKY 0834: 124/83 P 102 99.4 100% RA 0850: C/O DRY MOUTH, COLD 0840: 118/77 P: 104 100% RA 100% RA.... 0855: 118/84 P101 100% RA T 99.0 0905: TRANSPORTED BY EMT
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| 38 | 2021-01-06 | headache |
Facial numbness on the right side since Saturday 1/2/2020 woke up to half of my face numb the tip of...
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Facial numbness on the right side since Saturday 1/2/2020 woke up to half of my face numb the tip of my tongue tingled . and pressure on my right eye and I was not able to focus. I have headaches that come and go. my back is achy since last week and yesterday half of my body felt numb.
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| 38 | 2021-01-06 | headache |
Headache at the "back of the skull" that occurred 2 hours after the vaccine and went away by the aft...
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Headache at the "back of the skull" that occurred 2 hours after the vaccine and went away by the afternoon
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| 38 | 2021-01-06 | dizziness |
I think there should be a warning against drinking alcohol after the vaccine . Had the same amount a...
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I think there should be a warning against drinking alcohol after the vaccine . Had the same amount as I usually do, 2 mixed drinks, but felt exaggerated affects and dizzy. Speaking to others- 1 glass of wine felt like 2-3.
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| 38 | 2021-01-06 | runny nose, headache |
Itchiness on right side of body, Mild headache, running nose and moderate soreness around injection ...
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Itchiness on right side of body, Mild headache, running nose and moderate soreness around injection site.
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| 38 | 2021-01-06 | fever, fatigue, headache | Low grade fever, site soreness, fatigue, headache |
| 38 | 2021-01-06 | fatigue, chills | Myalgia Chills,fatigue Narrative: |
| 38 | 2021-01-06 | somnolence |
Pt in clinic for 1st COVID vaccination. Nurse reviewed screening checklist, nurse queried pt related...
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Pt in clinic for 1st COVID vaccination. Nurse reviewed screening checklist, nurse queried pt related to severe reactions to any injected medications or immunization previously. Pt denied any severe reaction history to injected medications or immunizations. Pt was administered COVID Pfizer injection approx. 0900. At approx. 0910 pt returned to nurses room reporting having stomach cramping. Pt reports attempted to use bathroom without success. Nurse notified Lead Nurse, NP. Emergency kit obtained, vital signs collected while Lead Nurse consulted Nursing Director, DNP, per consultation Lead Nurse contacted 9-1-1. Pt SpO2 stable in high 90's, pt did not present with difficulty breathing at that time, pt reported ongoing stomach pain and itching on abdomen. Pinprick petechiae observed on thoracic area, pt actively scratching. Per Lead Nurse, NP consultation with Nursing Director, DNP IM Bendaryl advised. Pt notified nurses of PMH allergy to Benadryl. Pt indicated when school-aged had anaphylactic reaction to penicillin and given IV Benadryl at that time, resulting in hives. Pt further reported allergic reaction to unknown facewash when 18 years old, when presented at MD office at that time was given IV Benadryl, subsequently sent to hospital at that time for severe reaction. Per consultation with Nursing Director epinephrine indicated. Nurse, RN administered epi-pen autoinjector 3mg at 09:22 (lot #G200810X, expiration 12/2021). Post epinephrine administration pt experienced nausea with vomiting and expressed feeling anxious. Pt affect became more somnolent with stomach upset. EMS arrived to clinic and pt consented to transport. Transfer of care to EMS approx. 09:45. RN
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| 38 | 2021-01-06 | throat swelling |
Swelling around the throat including tonsils & lymph nodes within 5 minutes of vaccine administratio...
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Swelling around the throat including tonsils & lymph nodes within 5 minutes of vaccine administration.
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| 38 | 2021-01-06 | throat swelling |
Swelling of hands, throat, and cheeks. Itching/tingling back of tongue. Resolved after 45 minutes. T...
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Swelling of hands, throat, and cheeks. Itching/tingling back of tongue. Resolved after 45 minutes. Took Benadryl 50 mg.
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| 38 | 2021-01-06 | headache |
headache; This is a spontaneous report from a contactable consumer, the patient. This 38-year-old fe...
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headache; This is a spontaneous report from a contactable consumer, the patient. This 38-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 03Jan2021 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medication were not reported. On 03Jan2021 (reported as early today), the patient reported she feels fine, but has a little bit of a headache. She did not know if her headache was due to the vaccine or other reasons. The patient wanted to know if she could take ibuprofen. The clinical outcome of the headache was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 38 | 2021-01-07 | dizziness | Burping. nausea, and dizziness |
| 38 | 2021-01-07 | shortness of breath, chills, fatigue, sweating |
Chills; Aches; Sweating; Dyspnea; Wheezing; Fatigue; This is a spontaneous report from a contactable...
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Chills; Aches; Sweating; Dyspnea; Wheezing; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in left arm, on 21Dec2020, at a single dose, for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 21Dec2020, the patient experienced chills, aches, sweating, dyspnea, wheezing, and fatigue. The events are considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date.
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| 38 | 2021-01-07 | malaise, sweating |
Clinic Manager reports that EE received first dose Covid-19. EE reports that after 15 minutes EE bec...
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Clinic Manager reports that EE received first dose Covid-19. EE reports that after 15 minutes EE became unwell and was sweating. EE reports that EE was seen in clinic by providers and had elevated blood pressure and hives
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| 38 | 2021-01-07 | headache, dizziness | FLUSH IN FACE, HEAT ON FACE, HEADACHE, DIZZINESS |
| 38 | 2021-01-07 | fatigue, sweating, malaise, fever, chills | Fatigue, fever (went up to 104, chills/ sweating, unwell |
| 38 | 2021-01-07 | headache, fever, fatigue | Fever, injection site tenderness, body aches, joint pain, severe headaches, fatigue |
| 38 | 2021-01-07 | fever |
Fever; This is a spontaneous report from a contactable Other-HCP (patient herself). This 38-year-ol...
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Fever; This is a spontaneous report from a contactable Other-HCP (patient herself). This 38-year-old female patient received the first dose of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 05Jan2021 at 08:45 at single dose for COVID-19 immunisation. Vaccine location was arm right. The patient was not pregnant. Relevant medical history included COVID 19 (prior to vaccination). Past drug history included allergy to penicillin. Relevant concomitant medication included birth control pill. The patient was vaccinated at hospital, age at vaccination was 38-year-old. No other vaccine was received in four weeks. Post-vaccination COVID test was not performed. On 05Jan2021 at 20:00, the patient developed fever. The patient was not treated for the event. The patient recovered from the event on unknown date. Information on the lot/batch number has been requested.
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| 38 | 2021-01-07 | headache |
Headache, NauseaVomiting, Palpitations, felt palpitations about 90 min post vaccine; lasted for abou...
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Headache, NauseaVomiting, Palpitations, felt palpitations about 90 min post vaccine; lasted for about 15 min; headach and mild nausea next morning Narrative: phone cal
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| 38 | 2021-01-07 | headache, chills, fever | Headache, nausea, fever, chills for approximately 24 hours. |
| 38 | 2021-01-07 | headache |
Headache; She was pregnant at the time of vaccination; She was pregnant at the time of vaccination; ...
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Headache; She was pregnant at the time of vaccination; She was pregnant at the time of vaccination; She was pregnant at the time of vaccination; This is a spontaneous report from a contactable nurse (patient). A 38-year-old pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) solution for injection, via an unspecified route of administration on left arm on 01Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included diabetes, and depression. Concomitant medications included escitalopram oxalate (LEXAPRO), ascorbic acid, biotin, minerals NOS, nicotinic acid, retinol, tocopherol, vitamin b NOS, vitamin D NOS (PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS]), progesterone (PROGESTERONE), and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient reported she was pregnant at the time of vaccination on 01Jan2021 15:00. She was at 9 weeks gestational period and will be due to deliver on 01Aug2021. The patient experienced headache on 02Jan2021 16:00 but did not receive any treatment. Outcome of the event headache was recovering while for the other event was unknown. No follow-up activities are needed. No further information is expected.
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| 38 | 2021-01-07 | shortness of breath, chills |
I was having trouble clearing my throat, felt like it was closing up; high heart rate/rapid heart ra...
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I was having trouble clearing my throat, felt like it was closing up; high heart rate/rapid heart rate agai; uncontrollable rigors; numb lips and hands; numb lips and hands; nausea; shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable Other Health Professional (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the left arm, on 30Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had her gall bladder and tonsils removed. Concomitant medication included rizatriptan and paracetamol (TYLENOL). The patient had no known allergies but mentioned that she cannot take the NSAIDs eventhough she was not allergic to them. She had no allergies to food or to other products. It was reported that within about 10 minutes of the injection of the vaccine, she had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea on 30Dec2020 at 09:30 AM. She was discharged from the ED (emergency department), went home and took a nap. Later that evening, she began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath and she was admitted to the emergency department again and given more IV medications. The onset of the events was reported to be 30Dec2020 at 09:30 AM with outcome of recovering. As a result of the events, the patient visited that Emergency room/department or urgent care. Treatment received with IV medications (unspecified), breathing treatment, and epinephrine injection. The patient had no covid prior vaccination. She had not had Covid test post vaccination.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events throat tightness, heart rate increased, chills, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 38 | 2021-01-07 | shortness of breath, dizziness |
Light headed, dizziness, pain in left arm from shoulder to elbow, fluzzy and numb feeling on roof o...
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Light headed, dizziness, pain in left arm from shoulder to elbow, fluzzy and numb feeling on roof of mouth, sob, constricted throat, altered sense of taste. Episode lasted for about 30 minutes. I sat and rested, focusing on my breathing and not panicking. I did not seek medical attention.
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| 38 | 2021-01-07 | fever, chills |
Low grade fever (99.5), aches, chills, nausea. Arm didn?t hurt as bad as 1st vaccination, but other...
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Low grade fever (99.5), aches, chills, nausea. Arm didn?t hurt as bad as 1st vaccination, but other symptoms were worse.
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| 38 | 2021-01-07 | fever | Low grade fever and body aches |
| 38 | 2021-01-07 | headache | Nausea, Headache |
| 38 | 2021-01-07 | throat irritation |
Patient complained of dry, tight, scratchy throat after receiving vaccine. Patient monitored and in...
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Patient complained of dry, tight, scratchy throat after receiving vaccine. Patient monitored and instructed to monitor at home.
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| 38 | 2021-01-07 | dizziness, fatigue |
Received vaccine 1/5/21. On 1/8/21 she felt dizzy and nauseated and fatigued. Blood pressure, pulse,...
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Received vaccine 1/5/21. On 1/8/21 she felt dizzy and nauseated and fatigued. Blood pressure, pulse, temperature, O2 level all within normal limits.
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| 38 | 2021-01-07 | chills |
Shaking chills approximately 12 hours after 2nd dose received. Severe rhinitis during the day on 1/7...
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Shaking chills approximately 12 hours after 2nd dose received. Severe rhinitis during the day on 1/7/21 which resolved the next day, 1/8/21.
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| 38 | 2021-01-07 | chills, fever |
Shaking chills, lasting 2-3 hours, onset about 10 hours after administration with associated fever A...
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Shaking chills, lasting 2-3 hours, onset about 10 hours after administration with associated fever Also had localized soreness at site of admin that began 4-6 hours after admin, and is still a little present 2 days post admin, but improving
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| 38 | 2021-01-07 | somnolence, body temperature increased, chills |
Symptoms - ? evening of 1/7 began with abd pain and diarrhea, morning of 1/8 reported to work and le...
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Symptoms - ? evening of 1/7 began with abd pain and diarrhea, morning of 1/8 reported to work and left half way through shift after feelings of chills, nausea. Patient reports she went home, took her temperature 99.7, took a nap and then re-took temperature at 1:40 pm (Tmax 100.8), no meds taken. Last day of work and shift - ? today Home remedies? - nap Any improvement? ? mild improvement Recommendation? Patient educated to continue to monitor her symptoms and to rotate Tylenol and motrin for fever and pain management, patient verbalized back understanding. Patient educated to continue to manage her symptoms and to follow the guidelines outlined in the Illness in the Workplace Policy. Patient denied COVID-19 exposure without proper PPE and denied travel. Patient verbalized back understanding and denied further questions at this time.
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| 38 | 2021-01-07 | headache |
Thursday morning 1/7/21, right side of face noticed jaw drooping, later progressed to bad headache, ...
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Thursday morning 1/7/21, right side of face noticed jaw drooping, later progressed to bad headache, bad taste in mouth then lost sense of taste. Pain on the right side of face/jaw area. Trouble speaking. Went to ER at hospital then transferred to another ER.
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| 38 | 2021-01-07 | malaise, dizziness |
While waiting ini observation area pt reported "not feeling well" was given water and asked to stay ...
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While waiting ini observation area pt reported "not feeling well" was given water and asked to stay for aditonal amoutn of time. SOrtly after she reported "feeling like i am goinog to pass out" . Lightheaded dizzy, no other physical complaints. Pt is cool, lips pale.
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| 38 | 2021-01-07 | headache |
Woke up in am day after shot with sever body aches, headache and nausea. That lasted for 24 hours. I...
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Woke up in am day after shot with sever body aches, headache and nausea. That lasted for 24 hours. Injection site was swollen right after it was administered and red and warm to the touch for 5 days.
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| 38 | 2021-01-07 | fever | fever after vaccine |
| 38 | 2021-01-07 | throat pain, headache, throat irritation |
left sided mild case of trigeminal neuritis that persisted beyond 48 hrs after vaccination given (sy...
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left sided mild case of trigeminal neuritis that persisted beyond 48 hrs after vaccination given (symptom-numbness); headache; gritty/sandy sensation in mouth; borderline intermittent scratchy/sore throat, gritty/sandy sensation in mouth; borderline intermittent scratchy/sore throat; lost taste; burning/tingling on tongue; burning/tingling on tongue; This is a spontaneous report from a contactable physician, the patient. A 38-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EK5730), intramuscular in the left arm on 28Dec2020 at 12:30 (at the age of 38-years-old) as a single dose for Covid-19 vaccination. edical history included trigeminal neuritis in the past twice, first from herpes simplex virus (HSV1) and second from flu shot a few years ago; acne and recurrent oral HSV 1, all from an unknown date and unknown if ongoing. The patient was allergic to sulfa. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications included drospirenone, ethinylestradiol (LORYNA) for OCP; prednisone (MANUFACTURER UNKNOWN), short course completed prior to vaccination; beclometasone dipropionate (QNASL); xylometazonline hychrochloride (SUDAFED) which was stopped before vaccination; valaciclovir hydrochloride (VALTREX); ascorbic acid (VITAMIN C) which was stopped before vaccination and multivitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020 at 12:45, the patient experienced left sided mild case of trigeminal neuritis that persisted beyond 48 hours with symptoms of numbness with decreased sensation on lateral part of V2 trigeminal nerve which started 10-15 mins after vaccination with small spot corner of mouth on left and involved lateral part of entire left side of face from corner of left eye down within 1-2 hours after received vaccine. The patient also experienced headache, borderline intermittent scratchy/sore throat, gritty/sandy sensation in mouth, at 12-14 hours after getting vaccine on 28Dec2020; got burning/tingling on tongue and then lost taste 100% for about 1 hour then started to slightly come back-and waxed and waned until later that evening and most was back to normal except sweet taste still gone. The events resulted in a doctor or other healthcare professional office visit. Therapeutic measures were taken for all of the events which included antihistamines and valaciclovir; and for the trigeminal neuritis only, methylprednisolone pack. The clinical outcome of the event trigeminal neuritis was recovering (lasted longer than 48 hours after vaccination); for headache, stomatitis, throat irritation, oropharyngeal pain, ageusia, tongue discomfort and paraesthesia oral was recovered (at 48 hours after vaccination).
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| 38 | 2021-01-07 | fatigue | nausea, fatigue, injection site painful |
| 38 | 2021-01-07 | headache, chills |
nausea; chills; Headache; This is a spontaneous report from a non-contactable Other healthcare profe...
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nausea; chills; Headache; This is a spontaneous report from a non-contactable Other healthcare professional. A 38-year-old female (not pregnant) patient received BNT162B2 on 22Dec2020 10:00 AM intramuscular Right arm at singe dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No Known allergies. Facility type vaccine was Hospital. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient had headache, nausea and chills on 24Dec2020. No treatment received. The outcome of the events was recovered. The seriousness was reported as no. No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
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| 38 | 2021-01-07 | shortness of breath, dizziness, fever |
severe dizziness; aches; chest pain; palpitations; extremely low blood pressure; fever; shortness of...
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severe dizziness; aches; chest pain; palpitations; extremely low blood pressure; fever; shortness of breath; This is a spontaneous report from a non-contactable nurse, the patient. A 38-year-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EK9231; Expiration date was not reported), via an unspecified route of administration in the left arm on 29Dec2020 at 09:15 (at the age of 38-years) as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took cefzil and experienced allergies. On an unspecified date, the patient experienced severe dizziness, shortness of breath, chest pain, palpitations, extremely low blood pressure, fever, and aches. The patient was seen in the emergency department for the events. Therapeutic measures for the events included medications and IV fluids; both not further specified. The outcome of the event severe dizziness, shortness of breath, chest pain, palpitations, extremely low blood pressure, fever, and aches was recovered. No follow up attempts are possible. No further information is expected.
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| 38 | 2021-01-08 | throat irritation |
About 15 minutes after the injection I felt a warm sensation throughout my body and it went away imm...
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About 15 minutes after the injection I felt a warm sensation throughout my body and it went away immediately. About 10 minutes after that, my throat started feeling scratchy/itchy/tingling, then my tongue and lips. After about 10 minutes it went away. I felt ok so I left the vaccination area and went back to my department I work in. For several hours the same symptoms came and went in waves, lessening over time. At 8:30pm the same day, I took 25 mg PO Benadryl to feel safe while sleeping. I felt fine the next day and reported it to the pharmacist in the vaccination clinic. I never felt like my airway was compromised.
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| 38 | 2021-01-08 | dizziness |
Dizziness & Tachycardia Narrative: Participant C/O dizziness upon ambulation shortly after completin...
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Dizziness & Tachycardia Narrative: Participant C/O dizziness upon ambulation shortly after completing a 15 minute observation period. Noted tachycardia with a heart rate of 137. Pt transported VIA wheelchair to the Emergency room triage area for further evaluation.
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| 38 | 2021-01-08 | fever |
Fever to 102.9, fevers first started 12 hours after administration. Requiring constant antipyretics...
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Fever to 102.9, fevers first started 12 hours after administration. Requiring constant antipyretics to decrease
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| 38 | 2021-01-08 | headache, body temperature increased, fever, chills |
Fever, chills, headache, upset stomach started at 1am. Unable to sleep until 3:45am. Woke at 7am wit...
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Fever, chills, headache, upset stomach started at 1am. Unable to sleep until 3:45am. Woke at 7am with temp of 99.2 and chills, headache. It is now 10:15am and fever is gone but headache remains.
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| 38 | 2021-01-08 | fatigue, headache |
Headache, Myalgia, Fatigue Narrative: Received vaccine on 12-20-20. On 12-21, came to work but did ...
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Headache, Myalgia, Fatigue Narrative: Received vaccine on 12-20-20. On 12-21, came to work but did not feel and so stayed home from work the following day 12-22. Now feeling better.
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| 38 | 2021-01-08 | fever, headache |
Headache, Myalgia, Fever, low back pain Narrative: Spoke to Occ health only, no medical attention,...
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Headache, Myalgia, Fever, low back pain Narrative: Spoke to Occ health only, no medical attention, has stayed out of work.
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| 38 | 2021-01-08 | headache | Headache, body aches, weird back pain . Took ibuprofen |
| 38 | 2021-01-08 | headache, runny nose, dizziness |
I was to dizzy to drive myself home. Vomiting, headache, off balance, nausea, runny nose, horrible...
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I was to dizzy to drive myself home. Vomiting, headache, off balance, nausea, runny nose, horrible body aches.
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| 38 | 2021-01-08 | fatigue | Muscle aches, nausea, fatigue, injecton site pain |
| 38 | 2021-01-08 | fever | Post vaccine 12 hours fever of highest 102.3 F, resolved by 8 am Wednesday 1-6-21 |
| 38 | 2021-01-08 | fatigue, headache | Severe sore muscles, headache, body ache, fatigue |
| 38 | 2021-01-08 | dizziness, cold sweat |
Woke up at 2:30 am feeling nauseous, broke out in cold sweat, got out of bed, went to restroom, ever...
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Woke up at 2:30 am feeling nauseous, broke out in cold sweat, got out of bed, went to restroom, everything went black and felt like I was going to pass out. Husband got to me and laid on the floor. Never passed out completely, but it was a very weird and odd feeling. Felt better after about 20 mins. Have felt great since. So did not go to primary care physician but felt the need to report.
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| 38 | 2021-01-09 | throat swelling, discomfort, chills, fatigue |
Body and extremities started tingling and felt very heavy, heart felt like it was racing, throat fel...
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Body and extremities started tingling and felt very heavy, heart felt like it was racing, throat felt like it was slightly swollen, chills, head felt foggy, instant fatigue
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| 38 | 2021-01-09 | chills, fatigue | Chills, joint pain, fatigue, local reaction. Benadryl, ibuprofen q6h |
| 38 | 2021-01-09 | malaise, fever |
Developed body aches, fever and malaise at approximately 12 hours after vaccination that lasted unti...
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Developed body aches, fever and malaise at approximately 12 hours after vaccination that lasted until 36 hours post vaccination
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| 38 | 2021-01-09 | chills, fatigue | Fatigue, body aches, arm pain, chills |
| 38 | 2021-01-09 | fever, headache, chills |
Fever 102 with chills, body ache, headache. Fever started 24 hours post vaccination. Subsided with ...
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Fever 102 with chills, body ache, headache. Fever started 24 hours post vaccination. Subsided with ibuprofen then relapsed 48 hours post vaccination.
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| 38 | 2021-01-09 | chills, fever |
Fever like symptom onset at 3:30pm on 01/08/2020 with chills. Temp at 99.8. Observed. Then temp at 4...
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Fever like symptom onset at 3:30pm on 01/08/2020 with chills. Temp at 99.8. Observed. Then temp at 4:30pm was at 100.8. Ibuprofen taken and sx resolved by 8pm the same day.
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| 38 | 2021-01-09 | chills, headache | Headache, body aches, arm soreness, nausea, chills |
| 38 | 2021-01-09 | fatigue |
I felt fine after the shot all day. I went to bed at 1030pm, woke up at 1130 hyperventilating (respi...
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I felt fine after the shot all day. I went to bed at 1030pm, woke up at 1130 hyperventilating (respiratory rate was 40+ and I couldn?t lower it), shaking uncontrollably (felt increasingly cold, though my temp was normal; my skin was cold to the touch but I felt like it was burning off), tachycardic (heart rate was 140bpm and I normally am at 60-80 at rest). My throat felt like it was closing and my face was swollen. I should have gone to the ER, but I wasn?t thinking clearly and didn?t know what to do with my small children. It took 2 hours until I stopped shaking, my heart rate returned to normal, and my breathing was under control. Since then I have mainly been fatigued, taking Tylenol for overall aches, and have not been able to tolerate much activity (can only stand for about 5 minutes at a time).
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| 38 | 2021-01-09 | fatigue, dizziness, headache, weakness |
I felt weak and with muscle fatigue the day after the shot. Also had a headache and neck muscle tens...
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I felt weak and with muscle fatigue the day after the shot. Also had a headache and neck muscle tension and mid back muscle tension. Joint pains as well. These subsided after 48 hours except for the neck and upper back muscle fatigue and mild soreness. This gave me a low grade headaches almost daily since the vaccine. I took ibuprofen a few times which helped. On the 6th I awoke at night and felt weak all over. I felt like I was falling in my bed. Mild dizziness. I went to work and felt extremely fatigued with muscle weakness but no neuro deficits. I feared some terrible autoimmune illness and took Decadron that day- 4mg tab BID. This helped my muscle weakness but left me with insomnia. The decadron is now wearing off after 4 days and I still have muscle weakness/fatigue. It takes considerable effort walking up the stairs. Yesterday my masseter muscles became fatigued with little chewing. My arms feel heavy when I lift them. The strange thing is that at night when I lie down I feel like my sympathetic nervous system is being triggered. I will get palpitations and feel just strange- I can't describe it. I took valium to sleep last night -5 mg tablets that my doctor gave me Saturday as there seems to be an anxiety panic component going on. I have no history of diagnosed anxiety or panic attacks- I have never felt this way before. Today I feel a little better but still have considerable muscle fatigue and neck and upper back muscle soreness and overall muscle tightness in my arms and legs- feels good to stretch kind of feeling. I have mild dizziness when standing up and turning too abruptly. But no considerable focal neuro deficits.
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| 38 | 2021-01-09 | skin warm, throat irritation |
Patient c/o tongue swelling, throat tingle and chest pain. Warm tingling around mouth. VS.Benadryl ...
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Patient c/o tongue swelling, throat tingle and chest pain. Warm tingling around mouth. VS.Benadryl 25 min 7:43, Epi Pen Eipi-Pen at 07:45, Rapid response called, Epi Pen working. Transferred to ED.
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| 38 | 2021-01-09 | fatigue, chills, body temperature increased, weakness |
Received vaccine on 1/6 at 0800pm 1/7 - 730am woke up with a very soar arm, difficult to move. 10am ...
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Received vaccine on 1/6 at 0800pm 1/7 - 730am woke up with a very soar arm, difficult to move. 10am felt very tired, like I was about to catch a cold. 12pm felt cold, had a temp of 99.9 F 3pm was very tired, chills, mild nausea, temp 100.8 F - took tylenol at this point 1000mg. Tylenol helped reduced fever and chills. Still continued to feel very tired and had no energy. Stomach continued to feel sensitive and had very little appetite. 10pm - fever returned 100.6 with chills - took another dose of 1000mg tylenol and went to sleep. Through out the night was hot and cold. 1/8 7am - I woke up had temp of 100.1F - no chills, still very tired, arm still very sore. Did not take tylenol. 9am - temp now 99.7 F - still very tired 10am - temp now 98.6F - nausea resolved, still had no appetite. Very tired, body felt sore and left armpit hurt when I moved, I noted no lymph nodes. Remainder of day I remained fever free, but continued to feel very tired and took a few naps. (this is not my norm, I do not nap). By dinner time appetite was better but stomach still felt tender. 1/9 - woke up feeling great, lots of energy, even went for a jog. Arm still a little sore.
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| 38 | 2021-01-09 | fatigue, malaise |
Same day of injection: general malaise and tiredness within 2 hours of shot Day 2: malaise and tired...
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Same day of injection: general malaise and tiredness within 2 hours of shot Day 2: malaise and tiredness lessened, but incredible soreness to injection site (left deltoid) Day 3: moderate diarrhea
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| 38 | 2021-01-09 | fever, headache, chills |
Severe arm pain, swelling at injection site, redness, warm to touch. Feverish, chills, headache, di...
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Severe arm pain, swelling at injection site, redness, warm to touch. Feverish, chills, headache, diarrhea, severe body aches, joint pain.
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| 38 | 2021-01-09 | chills, fever, headache, fatigue |
Started with chills about 10.5 hours after shot. Took temperature and noted a fever of 101.1F at the...
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Started with chills about 10.5 hours after shot. Took temperature and noted a fever of 101.1F at the 12 hour mark along with a headache and fatigue. Improved moderately with taking ibuprofen and rest, fever ended after 24hours post vaccine. Lingering headache for the next 12 hours. Completely resolved at 36 hours.
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| 38 | 2021-01-10 | body temperature increased |
(Saturday)rigors @about 730 PM with temp of 100.9. Tylenol 650mg taken. (Sunday)Body aches in th...
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(Saturday)rigors @about 730 PM with temp of 100.9. Tylenol 650mg taken. (Sunday)Body aches in the morning with temp of 100.5. Ibuprofen 600mg taken. Felt better about 3pm. (Monday) Pain/discomfort to armpit and numbness to Left arm (Arm that injection was given)
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| 38 | 2021-01-10 | dizziness, shortness of breath, sweating, throat swelling |
38-year-old female who is healthcare worker and received first dose of COVID vaccine (Pfizer). Immed...
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38-year-old female who is healthcare worker and received first dose of COVID vaccine (Pfizer). Immediately after receiving the vaccine, patient developed lightheadedness, flushing, hives, wheezing and throat swelling. Patient was treated in an emergency department with epinephrine, gradually improved and was able to be sent home with an EpiPen, prednisone, hydroxyzine, and famotidine. The next day, patient again developed shortness of breath and her husband administered the EpiPen. EMS arrived and gave another dose of IM epinephrine and IV diphenhydramine. On arrival to the emergency department, the patient was altered, diaphoretic, tachypneic, tachycardic, and stridulous. Patient was given multiple doses of IM epinephrine and started on epinephrine drip. Stridor continued and was unresponsive to nebulized albuterol. Patient was then intubated and placed on mechanical ventilation. Other treatments included solumedrol, pepcid, magnesium sulfate, nebulized epinephrine, and IV fluids. admitted to the intensive care unit, weaned off epinephrine drip, and extubated the next day. Patient was monitored on hospital floor for one additional day and was then discharged with no residual symptoms.
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| 38 | 2021-01-10 | fever |
7 days after my first Pfizer COVID vaccine, I developed mastitis. It began in the morning with mild ...
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7 days after my first Pfizer COVID vaccine, I developed mastitis. It began in the morning with mild generalized muscle and joint pain and progressed to moderate to severe joint pain, a fever of 102 degrees, and localized redness and swelling of the left breast over the course of 12 hours. Treatment with Cephalexin 500 mg PO QID for 14 days was initiated within 12 hours of onset. The systemic symptoms resolved within 24 hours of treatment onset and the breast redness and swelling resolved within 72 hours. While I am aware that an infectious mastitis is likely unrelated to the vaccine, I opted to report this incident because I have breastfed 3 children and have never had mastitis prior to this event and because of the limited information available on this vaccine in lactating women.
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| 38 | 2021-01-10 | headache, chills, sweating, fever, fatigue |
9:30 pm chills, escalating to shivering, then a fever and severe headache and arm pain throughout th...
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9:30 pm chills, escalating to shivering, then a fever and severe headache and arm pain throughout the night. Woke with a temp of 101.3 at 8am the next day, body aches, and headache. Fatigue and sweats until fever broke about 11am after more sleep. The afternoon decreased symptoms until only a mild headache and fatigue that night.
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| 38 | 2021-01-10 | headache, sweating, fever, chills |
Awoke that night after receiving 2nd dose of Pfizer COVID-19 vaccine with fever, sweats/chills and b...
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Awoke that night after receiving 2nd dose of Pfizer COVID-19 vaccine with fever, sweats/chills and body aches. Experienced difficulty sleeping the rest of the night due to symptoms and restlessness. Following day, I continued to have fever averaging 100 degrees F, body aches, chills and headache that brought me to tears. That evening, began experiencing severe nausea and involuntary shaking. Reported to ER for management of symptoms. Received fluids, ibuprofen, Zofran and Reglan as well as potassium. It is currently the following Monday so 5 days post vaccine and I continue to have intermittent nausea and headache.
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| 38 | 2021-01-10 | headache, chills |
Beginning the evening after receiving vaccine 1/5/21 patient complains of nausea, headache. The ne...
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Beginning the evening after receiving vaccine 1/5/21 patient complains of nausea, headache. The next day the patient symptoms were chills, headache, restless legs, and a slight tremor. By Saturday 1/9/21, the patient was experiencing worsening restless legs, and tremors to the point she could the sleep or work. Patient reported symptoms to the pharmacy on monday 1/11/21, chills, nausea, and headache had subsided and tremors and restless legs were improving.
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| 38 | 2021-01-10 | fever, headache |
Body aches and headache beginning at 4 am on 1/9/2021. Fever at 9:30 am 1/9/2021 to 100.5. Swollen ...
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Body aches and headache beginning at 4 am on 1/9/2021. Fever at 9:30 am 1/9/2021 to 100.5. Swollen left axillary lymph node noted. Sunday 1/10/2021 symptoms resolved except for lymph node enlargement and soreness at injection site. Taking tylenol and motrin with relief.
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| 38 | 2021-01-10 | dizziness |
C/O- Dizzy, light headed, states she had glasses of wine night prior, and massage this am before vac...
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C/O- Dizzy, light headed, states she had glasses of wine night prior, and massage this am before vaccination, cup coffee this am, no other food or liquid. Action- Monitored in OBS area, released after 30 minutes with no complaints
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| 38 | 2021-01-10 | throat irritation |
Developed throat itching and fullness approximately 45 minutes post vaccination. Between 1-1.5 hours...
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Developed throat itching and fullness approximately 45 minutes post vaccination. Between 1-1.5 hours, itching of head, neck, and face. No shortness of breath or rash identified. Diphenhydramine 50 mg PO and methylprednisolone 12 mg PO taken upon arriving home.
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| 38 | 2021-01-10 | dizziness |
Experienced flushing and lightheadedness, required extended monitoring. Returned to work after 35 mi...
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Experienced flushing and lightheadedness, required extended monitoring. Returned to work after 35 minutes of monitoring.
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| 38 | 2021-01-10 | dizziness |
Experienced flushing and lightheadedness. Required extended monitoring. Patient returned to work aft...
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Experienced flushing and lightheadedness. Required extended monitoring. Patient returned to work after 35 minutes of monitoring.
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| 38 | 2021-01-10 | shortness of breath, throat swelling |
Felt and appeared flushed, as well as feeling her throat closing up and being "unable to breathe" wi...
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Felt and appeared flushed, as well as feeling her throat closing up and being "unable to breathe" within 6 hours of receiving the immunization
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| 38 | 2021-01-10 | fever, chills, dizziness, headache, fatigue |
Fever up to 101.2 F, chills, severe headache( left temporal, right temporal then spread to forebrain...
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Fever up to 101.2 F, chills, severe headache( left temporal, right temporal then spread to forebrain, even walking coughing makes brain hurt like tingling, loose stool, long bone pain, peri orbital edema, neck stiffness, new onset low back, loss of appetite, loss of taste, insomnia, fatigue and dizziness. I feel like I have all repeat symptoms of covid, with worse headache and neckstiffness than actual infection. Fever last for 3 days and disappeared but headache continues and ended up in ER. CTA negative, D dimer<200
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| 38 | 2021-01-10 | dizziness |
I received the vaccine in the late afternoon. I immediately Felt off. I was up most of the night wit...
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I received the vaccine in the late afternoon. I immediately Felt off. I was up most of the night with nausea and when I woke in the morning I was having both dizziness and Nausea. The nausea has subsided but I am still experience waves of dizziness.
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| 38 | 2021-01-10 | fatigue, dizziness, headache |
Metallic taste in mouth, tingly behind eyes, lightheaded, warm sensation throughout chest for severa...
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Metallic taste in mouth, tingly behind eyes, lightheaded, warm sensation throughout chest for several hours, racing heart rate, sudden hot feeling, extreme headache, extreme fatigue, brain fog, irritability, pain at injection site.
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| 38 | 2021-01-10 | cough, throat irritation |
Metallic taste in the back of throat between 15-20 minutes post vaccination, noticeable swallowing a...
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Metallic taste in the back of throat between 15-20 minutes post vaccination, noticeable swallowing and throat irritation at 20-25 minutes post vaccination, tongue and lip numbness and throat tightness at 25-30 minutes, dry hacking cough at 30 minutes. Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions, coughing, speaking 1-2 word sentences, with tachycardia and tachypnea. Treated with IM epinephrine, IV solumedrol and IV Benadryl and IV Benadryl with marked improvement in symptoms.
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| 38 | 2021-01-10 | sweating, shortness of breath, dizziness |
Pfizer vaccine given at 2:55pm. 3:10 Patient felt hot, diaphoretic, dizzy. Assisted patient to wheel...
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Pfizer vaccine given at 2:55pm. 3:10 Patient felt hot, diaphoretic, dizzy. Assisted patient to wheelchair. Patient symptoms improved briefly. Continuously monitored oxygen saturation and pulse. 3:12pm 110/60, P 78, O2 98% RA. 3:15pm call 911 to requested EMS due to patient reporting shortness of breath, throat tightening, chest tightness. 3:18pm 130/80, P 101, O2 99% RA, administered oral diphenhydramine 25mg and 0.5mg Epi (1:1000) via IM injection in right deltoid. 3:25pm 130/80, P 85, O2 93%. Ambulance arrives at 3:28 pm received report and transports patient via ambulance to Hospital.
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| 38 | 2021-01-10 | dizziness, throat irritation | SCRATCHY THROAT , BLURRY VISION, LIGHTHEADEDNESS. SOLUMEDROL, BENADRLY, PEPCID. 1 LITER OF FLUIDS. |
| 38 | 2021-01-10 | throat pain, sweating |
Sore throat for a few hours after the injection Painful body aches, body sweats and chills in the ev...
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Sore throat for a few hours after the injection Painful body aches, body sweats and chills in the evening - Aleve worked temporarily and then the side effects got worse, took another Aleve and eventually was able to sleep it off Arm aches at site of injection - still tender t otouch
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| 38 | 2021-01-10 | headache, chills, fatigue |
That evening I started getting a sore arm. The next morning I woke up w/ a slight headache and just ...
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That evening I started getting a sore arm. The next morning I woke up w/ a slight headache and just did not feel right. As the day progressed I started having body aches, chills, extreme fatigue, still sore arm. I could not stand for long periods of time or I would start to fell like I was going fall right there in the floor.
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| 38 | 2021-01-10 | respiratory tract congestion, body temperature increased, fatigue, throat pain |
The night of the shot I noticed a painful, red, swollen, arm and couldn't sleep on it. 24 hrs after ...
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The night of the shot I noticed a painful, red, swollen, arm and couldn't sleep on it. 24 hrs after shot I started to feel extreme fatigue, muscle aches, slightly sore throat, mild congestion. I had a temperature of 99.1. I went to an urgent care and my BP was elevated (very unusual for me) 140/100 and HR 110 and temp still 99.1. They did a rapid swab on me that was negative. I continued to feel awful the rest of the day. On Sunday the next morning I awoke because I had a very swollen and sore lymph node in my left armpit. I took tylenol and did warm compresses. I had continued fatigue on Sunday and slept the whole day. I also continued with a high heart rate 110-130 with activity. My Bp was 117/70I had a pulse oximeter at home. My temp stayed 99. Monday morning I woke up feeling better. My HR was in the 80 and temp 98.3 and fatigue is gone. I still have mild soreness in my left arm but the redness is fine and warmth is gone. My left armpit is still sore
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| 38 | 2021-01-10 | cough | Wheezing, cough, tongue swelling |
| 38 | 2021-01-10 | shortness of breath, dizziness | chest tightness, trouble breathing, dizziness and blurry vision |
| 38 | 2021-01-10 | fatigue |
fatigue achy on 1/8 and nausea x 1 hour and redness at the injection site on 1/10. Pedialyte with im...
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fatigue achy on 1/8 and nausea x 1 hour and redness at the injection site on 1/10. Pedialyte with improvement of symptoms.
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| 38 | 2021-01-11 | chills, fatigue, fever, headache |
12/18/2020 , 12/19/2020 felt sore and felt fine then Tues, middle of night with head ache and heart ...
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12/18/2020 , 12/19/2020 felt sore and felt fine then Tues, middle of night with head ache and heart rate high blood did not feel good took tyler and head ache chills and heart rate high blood and e k g tack cardi tylernol fever on/ slight fever and lots of water and second 01/08/2020 email the second dose taken fine. Fatigue and tylernol and sore 01/11/2020 headache, headache
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| 38 | 2021-01-11 | headache, chills, fever |
At approx 0000 on 1/11 I started running a fever (102.3 oral), having severe body aches, massive hea...
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At approx 0000 on 1/11 I started running a fever (102.3 oral), having severe body aches, massive headache and uncontrollable shaking and chills
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| 38 | 2021-01-11 | throat pain, shortness of breath, dizziness |
Became very hot, flushing, dizziness, lightheaded, felt like passing out. Followed by jaw tightness ...
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Became very hot, flushing, dizziness, lightheaded, felt like passing out. Followed by jaw tightness and pain, tongue swelling, lip swelling, difficulty breathing, chest tightness, fast heartbeat, increased blood pressure. Given benadryl, epi, solu-medrol and pepcid. Kept for observation. After release, continuing to have intermittent hot flashes, itching all over face and body, occasional jaw tightness, sore throat and tongue, increase in pulse, O2 sats in low 90s,
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| 38 | 2021-01-11 | chills, sweating |
Body aches, chills, and sweats began 15 hours after receiving second dose of vaccine. These symptoms...
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Body aches, chills, and sweats began 15 hours after receiving second dose of vaccine. These symptoms lasted until 11:30 am. Alternating Tylenol and ibuprofen helped.
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| 38 | 2021-01-11 | headache | Facial cellulitis, eye swelling, headache, nausea |
| 38 | 2021-01-11 | chills, headache | Headache, Chills, Nausea |
| 38 | 2021-01-11 | weakness, dizziness, fatigue, headache |
I awoke the next morning after my 2nd dose with the following side effects: Extremely light headed ...
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I awoke the next morning after my 2nd dose with the following side effects: Extremely light headed to the point it was hard for me to walk without feeling like I would pass out, body aches, severe headache, nauseous but never vomited, extremely tired as if I were given a sleep aid, and weak. I called my primary care physician to see if there was anything I could take to help, they advised me to take Ibuprofen and Tylenol. I started to feel better a few hours after taking Ibuprofen. The next day I just had a headache and am feeling tired. I would say the most extreme symptoms lasted about 10 hours and started to slowly feel better after that.
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| 38 | 2021-01-11 | fever |
I had body ache, fever, vomiting, a nausea. It lasted for 3 days. I went to doctor. I receive bliste...
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I had body ache, fever, vomiting, a nausea. It lasted for 3 days. I went to doctor. I receive blister on my mouth. I was in bed and couldn't take anyting.
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| 38 | 2021-01-11 | fatigue |
Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and w...
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Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak; Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak; Jaw/neck/throat area became tight like tensing up; Hard to talk, was shouting out one word at a time; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms; My fingers move often, like a compulsion; This is a spontaneous report from a contactable health care professional, the patient (patient). A 38-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), intramuscular in the left arm on 28Dec2020 19:00 as a single dose, for COVID-19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital The patient had no known medical history or allergies. Concomitant medication included bupropion (BUPROPION), propranolol (PROPRANOLOL), sertraline (SERTRALINE), ethinylestradiol, levonorgestrel (PORTIA 21). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 28DEC2020, the patient experienced Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak. Jaw/neck/throat area became tight like tensing up. Hard to talk, was shouting out one word at a time. My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms. My fingers move often, like a compulsion. Adverse event resulted in a physician office visit. No treatment was given for the event. The clinical outcome of Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak. Jaw/neck/throat area became tight like tensing up. Hard to talk, was shouting out one word at a time. My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms. My fingers move often, like a compulsion was not recovered.
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| 38 | 2021-01-11 | headache, fatigue |
Lymph nodes swollen under L) arm X 5 days very painful , Fatigue X 3 days , headache on left side on...
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Lymph nodes swollen under L) arm X 5 days very painful , Fatigue X 3 days , headache on left side only including neck and torso left side only X 4 days .
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| 38 | 2021-01-11 | fatigue, headache |
Severe fatigue; Headache; Body aches; Feel like my skin is crawling; Nauseous; Arm is very sore; I f...
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Severe fatigue; Headache; Body aches; Feel like my skin is crawling; Nauseous; Arm is very sore; I feel like I'm dying; This is a spontaneous report from a contactable healthcare professional. A 38-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as COVID-19 vaccine), via an unspecified route of administration left arm on an unspecified date (unknown lot number and expiration date) at a single dose; and via an unspecified route of administration left arm on 04Jan2021 18:00 [06:00 PM] (lot number: Eh9899; expiration date: unknown) at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had known allergies to amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine administered in a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Jan2021 17:00 [05:00 PM], the patient experienced severe fatigue, headache and body aches- feel like her skin is crawling and was hit by a freight train. The patient has never had a reaction like this before. The patient was also nauseous, and her arm is very sore, but she doesn't even notice since she feeling like she's dying. The patient has not been tested for COVID-19 since the vaccination. The treatment received by the patient for the adverse event included paracetamol (TYLENOL)/ibuprofen around the clock (OTC medication). The patient reported that the events was non-serious. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the event was not resolved. The following information on the batch/lot number has been requested.
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| 38 | 2021-01-11 | fatigue, dizziness, headache |
Swelling that looked like an egg under my arm, very visible very very sore; Swelling that looked lik...
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Swelling that looked like an egg under my arm, very visible very very sore; Swelling that looked like an egg under my arm, very visible very very sore/couldn't move my arm without it hurting; rash; hot to the touch; bruising; dizziness; nauseous; headache; body ache; muscle ache; very tired; joint pain; loss of appetite; This is a spontaneous report from a contactable healthcare professional. A 38-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ET1685, expiration date not reported), via an unspecified route of administration on the left arm, on 30Dec2020 at 11:45 at a single dose for Covid-19 immunization. Medical history included latex and shellfish allergy. Patient was diagnosed with Covid-19 prior to vaccination. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ergocalciferol (VITAMIN D), calcium, topiramate, and cyanocobalamin (vitamin B12). The patient previously took erythromycin, terbutaline, iodine and experienced drug allergies. On 30Dec2020 at 11:45, the patient experienced swelling that looked like an egg under her arm, very visible very very sore, rash, hot to the touch, bruising, dizziness, nauseous, headache, body ache, muscle ache, very tired, couldn't move arm without it hurting, joint pain, and loss of appetite. On 04Jan2021, the patient had a nasal swab and was tested for COVID-19, both with unknown result. The patient did not receive treatment for the events. The outcome of the events was recovering. The reporter assessed the events as non-serious.
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| 38 | 2021-01-11 | fatigue, somnolence | Vomiting and fatigue/drowsiness on 01/10/2021, fatigue continued through present (1/12/21) |
| 38 | 2021-01-11 | migraine, chills |
caller stated that vaccine caused chills, heart rate increase, nausea, vomiting, body aches and mig...
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caller stated that vaccine caused chills, heart rate increase, nausea, vomiting, body aches and migraines lasting 72 hours.
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| 38 | 2021-01-11 | headache, chills, fever |
diarrhea; headache; fever with 100.4; joint and neck pain; joint and neck pain; heart rate racing (h...
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diarrhea; headache; fever with 100.4; joint and neck pain; joint and neck pain; heart rate racing (higher than normal); intense nausea; pain in stomach; vomiting; chills; This is a spontaneous report from a contactable Other HCP(patient). The 38-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), via an unspecified route of administration in deltoid left on 04Jan2021 12:00 at single dose for COVID-19 vaccination. Medical history included covid-19 from Oct2020 to Nov2020 for five weeks , ongoing depression, ongoing anxiety. Ongoing concomitant medication included escitalopram oxalate (LEXAPRO) for depression, clonazepam (KLONOPIN) for anxiety. The patient experienced heart rate racing on 05Jan2021 with outcome of recovering , intense nausea on 04Jan2021 23:00 with outcome of recovering , pain in stomach on 04Jan2021 23:00 with outcome of recovering , vomiting on 04Jan2021 with outcome of recovering , chills on 04Jan2021 with outcome of unknown , fever with 100.4 on 05Jan2021 with outcome of unknown , joint and neck pain on 05Jan2021 with outcome of not recovered, headache on 05Jan2021 02:00 with outcome of not recovered , diarrhea on 05Jan2021 05:30 with outcome of unknown. It was reported she got her first dose yesterday (04Jan2021) and she was concerned with the side effects she is experiencing because they were so severe. She got the COVID Vaccine around 12:00. After getting the vaccine she felt fine and then went to bed. However, after around 11 pm she woke up from bed with intense nausea and pain in her stomach. She got up and started vomiting. She could not stand up right due to the pain. The nausea was so intense she had to crawl on the floor. She also had chills and had to bundle up in bed. She checked her temperature and she had a fever. She also had joint and neck pain. She also had a headache. She took some Tylenol. She later started to feel like she was sick again, but she did not vomit again. She later felt like her heart was racing. She could not go back to sleep because her heart rate was higher than normal. Then this morning she had diarrhea. She stated she has called out of work due to this. She explained in regards to the chills she took Tylenol and it is still in her system. She does not know if it will come back or not. She clarified the fever she had her temperature was 100.4 on 05Jan2021 and it went down with Tylenol. It went down to 99.5. The joint and neck pain started around the same time in the middle of the night around midnight. The headache started around two in the morning. Her heart rate racing started around midnight. As of now her heart rate had decreased, but it was not back to her normal rate. She had a Pulse Ox and she can keep track of her heart rate. Normally her heart rate is 48 beats per minute. Her heart rate went up to 95 beats per minute. The diarrhea started around 05:30 this morning. She has had no more episodes since 07:30. She had a total of two episodes. There was no Emergency Room or Physician's Office needed. There was no prior vaccinations within 4 weeks. Therapeutic measures(Tylenol) were taken as a result of chills , fever with 100.4, joint and neck pain, headache (headache). Events were assessed as non-serious by the reporter.
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| 38 | 2021-01-11 | headache |
pain at injection site; body aches; mild headache; This is a spontaneous report from a contactable n...
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pain at injection site; body aches; mild headache; This is a spontaneous report from a contactable nurse (patient herself). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142; expiry date: unknown) via an unspecified route of administration, on 04Jan2021, at 0.3 mL, single for COVID-19 immunization. Patient has no relevant medical history. Concomitant medications were not reported. Prior to taking vaccine, she did an antibody test and it was positive for antibodies s in Nov2020, she remembered that she went for a complete physical. All COVID tests were negative but the antibody test was positive. She did a rapid test a week before the vaccine at the end Dec2020. The PCR Test was a couple months before the vaccine in Apr2020 and it was negative. During that time in Apr2020 she had mild symptoms and was not feeling well but then she felt better. The doctor gave her azithromycin and vitamins, a week later she was better. At her job they were doing COVID test every 2 weeks, but she was negative. She had no more symptoms. She has had no issues with vaccines in the past. She would get unspecified flu shots at work for flu vaccination, but would get mild pain at the injection site. Patient received PFIZER-BIONTECH COVID-19 VACCINE on 04Jan2021 and had been experiencing pain at injection site, mild body aches, and mild headaches. Her 1st dose was on 04Jan2021 at 4 o clock. The pain at injection site began on 05Jan2021. The body aches and headache also started on 05Jan2021, but she noticed relief with Tylenol. She has called her physician since she does not want to go in office. Her symptoms were ordinary and mild but bothersome, she doesn't know with this vaccine and what she would be feeling and decided on staying home. The pain at injection site stopped sometime between yesterday and today. Her 2nd dose is scheduled on 25Jan2021. Outcome of the event pain at injection site was recovered on an unspecified date in Jan2021, while for the remaining events was recovering.
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| 38 | 2021-01-12 | fatigue, chills |
13 hours after vaccination developed severe arm tenderness at injection site, aches and chills. The...
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13 hours after vaccination developed severe arm tenderness at injection site, aches and chills. These lasted about 12 hours. Aches and exhaustion continued another 6 hours.
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| 38 | 2021-01-12 | dizziness |
@0928 about 20 minutes post vaccine, she stated she was starting to feel tingling to her neck and ar...
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@0928 about 20 minutes post vaccine, she stated she was starting to feel tingling to her neck and arms bilaterally. NAD, no SOB, v/s 154/110 (normal for her is 102/80s). 98% RA, hr 95, 96.9 temp and no pain. Did report dizziness. patient has a history of anaphylaxis. Evaluated her for 30 minutes after onset of symptoms. C/o anxiety and feeling seasick, never experienced respiratory distress at the end of her additional 30 minutes she reported feeling better.
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| 38 | 2021-01-12 | chills, fatigue, headache |
At 9:30 pm teeth chattering, joint pain, fatigue, headache, chills. I was exp nausea however I have ...
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At 9:30 pm teeth chattering, joint pain, fatigue, headache, chills. I was exp nausea however I have that anyway with my pregnancy.(estimated date of delivery 8/3/2021).
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| 38 | 2021-01-12 | body temperature increased |
Began with shooting sharp pains in left foot gradually going up my left leg. At that point I took al...
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Began with shooting sharp pains in left foot gradually going up my left leg. At that point I took aleve and a trazadone in hopes of getting some rest. I fell asleep. I woke up around 0200 on 1/13/21 with extreme muscle and joint aches, a sensation of pins, needles, and tingling all over my body I felt very jittery and was actually shaking slightly throughout the ordeal. I felt like my nervous system was overloaded and my perception of pain was extremely heightened. At one point during this 4 hour period I had a visual hallucination. By 0600 I was feeling better- more relaxed. Muscle aches and sore joints are still present today. Also have a slight increase in temp 99.6 and injection site pain.
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| 38 | 2021-01-12 | fatigue | Body Aches, Fatigue, Injection site pain |
| 38 | 2021-01-12 | chills, headache | Body ache, chills, headache. Improving. |
| 38 | 2021-01-12 | chills, fatigue | Fatigue, body aches and chills |
| 38 | 2021-01-12 | fatigue, headache, fever |
Fatigue, severe muscle aches, fever of 101.9 and a terrible headache. I only lasted a day and a half...
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Fatigue, severe muscle aches, fever of 101.9 and a terrible headache. I only lasted a day and a half .
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| 38 | 2021-01-12 | fever, headache, chills, sweating, malaise | Fever 102, myalgias, arthalgia, malaise, headach, chills, sweats Lasted about 6 hours |
| 38 | 2021-01-12 | headache, fever | Fever headache body aches nausea chest pain Tylenol |
| 38 | 2021-01-12 | fatigue | Left supraclavicular adenopathy. Fatigue. Joint pain. |
| 38 | 2021-01-12 | fever, fatigue, chills | Low-grade fever, chills, fatigue, body-aches, specifically aching neck, |
| 38 | 2021-01-12 | headache, dizziness |
Patient presented to Facility MD Experiencing Flushing, HA, elevated BP, Faint with Rapid HRT Beat. ...
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Patient presented to Facility MD Experiencing Flushing, HA, elevated BP, Faint with Rapid HRT Beat. She was given water, Juice and laid down. After 30-40 minutes sxs subsided. Spoke to pt said she was Feeling much Better. Spoke to nurse at Rehab center. Pt reported she was Feeling much better By 5pm on 1-12-21.
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| 38 | 2021-01-12 | dizziness |
Patient vaccinated at 1715. Almost immediately after vaccination patient experienced dizziness and ...
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Patient vaccinated at 1715. Almost immediately after vaccination patient experienced dizziness and tongue tingling. Diphenhydramine 50 mg IM was administered at 1726. Patient progressed to swollen tongue and inability to swallow. Epinephrine 0.3 mg IM administered at 1800. Patient transported to ED. In ED patient received fluids, famotidine 20 mg at 1840, and dexamethasone 12 mg IV at 1858. Patient symptoms resolved and she was discharged.
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| 38 | 2021-01-12 | chills, fatigue, fever |
Soreness (Left Arm) x 2 days Fatigue (Intermittently) / 7 days Fever (Intermittently) / 7 days Body ...
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Soreness (Left Arm) x 2 days Fatigue (Intermittently) / 7 days Fever (Intermittently) / 7 days Body Ache/ 3days Chills /24 hrs.
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| 38 | 2021-01-12 | nerve pain |
Systemic: Nerve pain along left arm up along shoulders into neck, numbness, tingling, seems to subsi...
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Systemic: Nerve pain along left arm up along shoulders into neck, numbness, tingling, seems to subside after 30 minutes, but still lingering; symptoms lasted 1 day.
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| 38 | 2021-01-12 | chills, headache, fever |
Woke up to chills, then fever developed, up to 100.8. Fever/chills/body aches/headache lasted until ...
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Woke up to chills, then fever developed, up to 100.8. Fever/chills/body aches/headache lasted until the evening of 1/12. Felt miserable
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| 38 | 2021-01-12 | headache, fatigue |
bad body aches, muscle pain, Headache, fatigue, still ongoing, had 2 negative tests for COVID since ...
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bad body aches, muscle pain, Headache, fatigue, still ongoing, had 2 negative tests for COVID since onset of symptoms
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| 38 | 2021-01-12 | weakness, fever |
nauseous , weakness, fever, racing heart. All symptoms started about 5 hours after vaccination. Feve...
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nauseous , weakness, fever, racing heart. All symptoms started about 5 hours after vaccination. Fever highest so far at 101.6 , heart rate 132 at highest taken.
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| 38 | 2021-01-12 | dizziness |
reports feeling dizzy, walked over to EMS for eval and reported feeling anxious and better within 5 ...
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reports feeling dizzy, walked over to EMS for eval and reported feeling anxious and better within 5 minutes, sent home to husband waiting in car
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| 38 | 2021-01-13 | body temperature increased, headache, fatigue, cold sweat, chills, weakness |
1/12: 12:01am: Shaking chills, body pain, headache, nausea, faint, skin sensitivity, pain at injecti...
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1/12: 12:01am: Shaking chills, body pain, headache, nausea, faint, skin sensitivity, pain at injection site left arm. Temp 98.6 1/12: 0600am: Shaking chills, cold sweat, faint, nausea, headache, body pain, fatigue, skin sensitivity, pain injection site. 1/12: 0630am: Same as above, Temp 100.9, took Ibuprofen 3 tabs. 1/12: 0730am: Less of all symptoms, ate food. 1/12: 12:30pm: Headache, body aches and pains, weakness, fatigue, nausea, skin sensitivity, pain at injection site. 1/12: 1:12pm: Temp 99.5. took ibuprofen 3 tabs. 1/12: 2:15pm-3:40pm: Breakthrough body aches, pains, headache, skin sensitivity, pain at injection site. 1/12: 7:40pm: Body aches, tired. Temp 98.3. took Ibuprofen 3 tabs. 1/13: 0800: Slept well, no further pain medication, no further side effects except mild soreness at injection site. 1/24: 0800: no soreness to injection site.
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| 38 | 2021-01-13 | fatigue, fever, cough, chills |
12 hours after vaccine Fever, chills, muscle pain, joint pain lasting 14 hours. followed by tightnes...
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12 hours after vaccine Fever, chills, muscle pain, joint pain lasting 14 hours. followed by tightness in chest lasting 14 hours. Dry cough lasting 5 hours. Swollen lymph nodes on injection side arm pit lasted 48 hours. Tender abdomen, nausea started at 24 hour mark and lasted about 18 hours. Fatigue lasted 72 hours post vaccine.
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| 38 | 2021-01-13 | chills, headache, fever, fatigue | Fever chills headache fatigue |
| 38 | 2021-01-13 | fever, chills, headache |
Fever of 101.5° f, headache, chills, body ache, joint pain, inner ear pain in both ears and swollen...
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Fever of 101.5° f, headache, chills, body ache, joint pain, inner ear pain in both ears and swollen painful lymph node around collarbone on left side. Collarbone areas are visibly different due to swelling. Most symptoms resolved within 36 hours of second dose of Pfizer vaccine. However, swollen lymph node in left clavicle area has continued to get more painful and swollen. Will seek medical treatment if this does not resolve.
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| 38 | 2021-01-13 | chills, fever |
Fever, chills, body aches, headache. Injection site is red and inflamed. It is also swollen and a...
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Fever, chills, body aches, headache. Injection site is red and inflamed. It is also swollen and a hard lump.
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| 38 | 2021-01-13 | fatigue, headache | Headache, body aches, fatigue |
| 38 | 2021-01-13 | fever, headache, chills | Low grade fever, chills, body aches, headache |
| 38 | 2021-01-13 | throat swelling | Milks swelling of throat |
| 38 | 2021-01-13 | fatigue | Sever sore arm at injection site and to move arm, body aches, and fatigue. |
| 38 | 2021-01-13 | headache, chills | Soreness at the injection site, arm pain, headache and full body chills |
| 38 | 2021-01-13 | chills, fever, fatigue | Subjective fever, chills, myalgias, lymphadenophathy, tachycardia, fatigue |
| 38 | 2021-01-13 | malaise, chills, dizziness |
Symptoms - EE reports after vaccine she waited the 30 minute observation period and felt fine. At ...
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Symptoms - EE reports after vaccine she waited the 30 minute observation period and felt fine. At approximately 7:00 pm EE reports she went to store and when she went to get out of her car she felt really dizzy. EE reports she hadn?t eaten much that day so tried to eat some chocolate covered pretzels and coke. EE denied syncope. EE reports she started feeling ?chest tightness? and starting panicking. EE denies airway issues and SOB. EE said she got nervous and went to Hospital across the street for assessment. EE reports at triage her SPO2 was 100% but slightly tachycardiac. EE reports after her triage assessment she called her daughter to come pick her up and did not seek further medical care. EE reports when she got home she started with generalized itchiness, denies rash. EE reports she took 50 mg Benadryl, 25 mg Atarax, and 40 mg Pepcid at 8:45 PM. EE reports not change in itchiness and took 2nd dose of 50 mg Benadryl around 01:30 (1/14). EE reports she woke up around 06:45 (1/14) with bilateral arm bruising from scratching overnight per EE and feeling chilled. Last day of work and shift - ? scheduled to work tonight (1/14) Home remedies? ? see symptoms for home remedies Any improvement? ? mild improvement Recommendation? EE encouraged to continue to monitor symptoms and to contact EH vaccine support line with further questions or concerns. EE encouraged to take Claritin and Benadryl as outline by the Medical Directive at TCH. EE educated to only take Benadryl if she will be at home today and that is she unable to take Benadryl when at work, EE verbalized back understanding. EE educated if she is still feeling unwell for her shift tonight, to notify her manager and to manage per hospital Illness in the Workplace Policy. EE denied further questions at this time.
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| 38 | 2021-01-13 | dizziness |
Symptoms - EE reports after vaccine she waited the 30 minute observation period and felt fine. At ...
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Symptoms - EE reports after vaccine she waited the 30 minute observation period and felt fine. At approximately 7:00 pm EE reports she went to store and when she went to get out of her car she felt really dizzy. EE reports she hadn?t eaten much that day so tried to eat some chocolate covered pretzels and coke. EE denied syncope. EE reports she started feeling ?chest tightness? and starting panicking. EE denies airway issues and SOB. EE said she got nervous and went to hospital across the street for assessment. EE reports at triage her SPO2 was 100% but slightly tachycardiac. EE reports after her triage assessment she called her daughter to come pick her up and did not seek further medical care. EE reports when she got home she started with generalized itchiness, denies rash. EE reports she took 50 mg Benadryl, 25 mg Atarax, and 40 mg Pepcid at 8:45 PM. EE reports not change in itchiness and took 2nd dose of 50 mg Benadryl around 01:30 (1/14). EE reports she woke up around 06:45 (1/14) with bilateral arm bruising from scratching overnight per EE and feeling chilled. Last day of work and shift - ? scheduled to work tonight (1/14) Home remedies? ? see symptoms for home remedies Any improvement? ? mild improvement Recommendation? EE encouraged to continue to monitor symptoms and to contact EH vaccine support line with further questions or concerns. EE encouraged to take Claritin and Benadryl as outline by the Medical Directive at hospital. EE educated to only take Benadryl if she will be at home today and that is she unable to take Benadryl when at work, EE verbalized back understanding. EE educated if she is still feeling unwell for her shift tonight, to notify her manager and to manage per hospital Illness in the Workplace Policy. EE denied further questions at this time.
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| 38 | 2021-01-13 | chills, sweating, fever |
Within 10 minutes of receiving the vaccine, my heart began to race and I became very warm and sweaty...
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Within 10 minutes of receiving the vaccine, my heart began to race and I became very warm and sweaty. I was brought into another room for monitoring and my heart rate was above 100. After some breathing exercises, it came back down to the high 70s for a few minutes but then increased again into the 90s, at one point it was 113. My chest and throat then began to feel tight and I began sweating again. My face also felt funny on my right cheek. At that point I was first given 25 mg of benedryl then epinephrine. I was then taken to the emergency room via ambulance and was observed for approximately an hour. I was given an additional 25 mg of benedryl and discharged at 4:55pm. I was diagnosed with an allergic reaction and prescribed 25 mg of benedryl every 6 hours over the next 24 hours. The following morning, I experienced a hot flash with profuse sweating followed by chills. I was very tired and felt feverish throughout the day on 1/12 and stayed home from work. On 1/13 I still felt tired but was able to work. Today I feel mostly normal but still occasionally have had heart palpitations.
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| 38 | 2021-01-13 | headache |
sever body aches; head ache; nausea; Arm where vaccine was giving was swollen and red; Arm where vac...
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sever body aches; head ache; nausea; Arm where vaccine was giving was swollen and red; Arm where vaccine was giving was swollen and red; Arm where vaccine was giving was swollen and red and warm to the touch; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient (no pregnancy) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at site of right arm at 15:00 on 28Dec2020 at single dose for COVID-19 immunization. Medical history included eczema psoriasis, allergies: Augmentin, and birth control. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC) for birth control within 2 weeks of vaccination and levocetirizine dihydrochloride (XYZAL). At 06:00 on 29Dec2020, the patient experienced sever body aches, headache and nausea. Arm where vaccine was giving was swollen and red and warm to the touch, body aches lasted for 24 hours, arm issue didn't not go away for 5 days. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. This case was identified as non-serious by reporter. The outcome of event arm where vaccine was giving was swollen and red and warm to the touch was recovered in Jan2021; of rest events was recovered at 06:00 on 30Dec2020.
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| 38 | 2021-01-14 | chills, fever, headache, fatigue |
2000 - neck pain, headache 2200 - mild body aches 0235 - severe chills, muscle/joint pain, headache....
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2000 - neck pain, headache 2200 - mild body aches 0235 - severe chills, muscle/joint pain, headache. 0600 - fever 102.5F tympanic, took Tylenol 1000 mg + ice packs 0730 - temp 101.9 F; headache severe w/ nausea 0800 - took ibuprofen 600 mg; fatigue, took nap 0930 - temp 100.4 F 1400 - headache continues but much less severe; temp 99.0 F
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| 38 | 2021-01-14 | headache, fatigue, chills, fever |
Developed a fever of 101 12 hours post vaccine administration along with other symptoms. Took Tyleno...
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Developed a fever of 101 12 hours post vaccine administration along with other symptoms. Took Tylenol at 03:20 am with improvement in symptoms. Fever up 100.7 persisted after Tylenol wore off along with myalgias. No other symptoms beyond what was listed. Employee Health was contacted. chills, fatigue, fever, headache, injection site pain and new or worsened muscle pain
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| 38 | 2021-01-14 | fever, headache, chills, fatigue |
Fever at 103.1; Chills; Body aches; Fatigue; Headache; First dose administered on 19Dec2020; second ...
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Fever at 103.1; Chills; Body aches; Fatigue; Headache; First dose administered on 19Dec2020; second dose administered on 07Jan2021; This is a spontaneous report from a non-contactable nurse (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 (12:00) (Lot number: EL0140; Expiration date was not reported), and then the second dose on 07Jan2021 (06:00) (Lot number: EK9231; Expiration date was not reported), both intramuscularly on the left arm at a single dose for COVID-19 immunization at the hospital. The patient's medical history and concomitant medications were not reported. The patient's first vaccine dose was received on 19Dec2020, and the second dose was received on 07Jan2021 (06:00). On 07Jan2021 (23:00), the patient had fever at 103.1 (unit was not reported); chills; body aches; fatigue; and headache. The patient did not receive any treatment for the reported adverse events. The outcome of the events was recovering for 'fever at 103.1 (unit was not reported)', 'chills', 'body aches', 'fatigue' and 'headache'; and was unknown for 'first vaccine dose was received on 19Dec2020, and the second dose was received on 07Jan2021'. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. No follow-up attempts are possible. No further information is expected.
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| 38 | 2021-01-14 | fever, chills | Fever, chills, hives, body aches |
| 38 | 2021-01-14 | headache | Headache |
| 38 | 2021-01-14 | fever, sweating, fatigue, chills |
I woke up 12 hours after vaccination with fever, chills, and body aches. This lasted approximately 3...
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I woke up 12 hours after vaccination with fever, chills, and body aches. This lasted approximately 36 hours with extreme fatigue and sweating over the course of 2 days.
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| 38 | 2021-01-14 | chills | Im having sime pretty aggressive chills and nausea |
| 38 | 2021-01-14 | migraine |
Migraine headache; This is a spontaneous report from a contactable nurse reporting for herself. A 38...
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Migraine headache; This is a spontaneous report from a contactable nurse reporting for herself. A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular from 20Dec2020 11:00 in left arm to 20Dec2020 11:00 at single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medication included cetirizine hydrochloride (ZYRTEC). On 20Dec2020 17:00, the patient experienced migraine headache approximately 6hrs after injection. The patient recovered on unspecified date. No treatment was given to the patient for the event. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 38 | 2021-01-14 | fatigue, fever, dizziness |
My heart rate, I was like in AFib; very high fever of 103; dizzy, light headed; arms sore; exhausted...
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My heart rate, I was like in AFib; very high fever of 103; dizzy, light headed; arms sore; exhausted like an extreme fatigue; palpitations; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration on 30Dec2020 at 38-years-old at a single dose for COVID-19 immunization. Medical history included blood clotting disorder from an unknown date and unknown if ongoing. The patient experienced the following events and outcomes: my heart rate, I was like in AFib (medically significant) on 31Dec2020 with outcome of recovering, very high fever of 103 (non-serious) on 31Dec2020 with outcome of unknown, dizzy, light headed (non-serious) on 31Dec2020 with outcome of unknown, arms sore (non-serious) on 31Dec2020 with outcome of unknown, exhausted like an extreme fatigue (non-serious) on 31Dec2020 with outcome of not recovered, palpitations (non-serious) on 31Dec2020 with outcome of not recovered. The clinical course was reported as follows: The patient stated, "the day after the shot I got a very high fever of 103. I was dizzy, lightheaded. My heart rate I was like in AFib, it was going from 60s to 50s all over the place. And this was the next day after the vaccination. That evening nothing my arms was just sore. But the next day all of these side effects just started in and even still today I just feel so exhausted like an extreme fatigue and I am still getting like palpitations." The patient stated, "So I went to urgent care and they check my vitals and stuff and when they wanted me to send me to the hospital. But I told them I will get a ride and I go by myself just because I didn't want, capable of an ambulance ride and I ended up just going home because I couldn't get a hold up anybody. So, I came home and took my blood thinner medication because I do have blood clotting disorder." In regard to the outcomes of the events, the patient stated, "I am not experiencing all of them still definitely my heart is much better. I am still getting palpitations but nothing near how it was that first day. I am experiencing extreme fatigue."
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| 38 | 2021-01-14 | migraine, throat pain | Nausea, racing heart, shakey, migraine, sore throat |
| 38 | 2021-01-14 | throat pain, headache | Racing hearr, shaking, body aches, head hurts so bad i cant walk, sore throat |
| 38 | 2021-01-14 | headache, dizziness, fatigue |
Shakiness, feeling of wanting to faint, headache, fatigue, exhaustion , nauseous So far I have taken...
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Shakiness, feeling of wanting to faint, headache, fatigue, exhaustion , nauseous So far I have taken Excedrin
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| 38 | 2021-01-14 | influenza like illness, chills |
Took 2nd dose shot at approx 9am on 1/13/21. By approximately 5pm began to experience flu like symp...
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Took 2nd dose shot at approx 9am on 1/13/21. By approximately 5pm began to experience flu like symptom with no fever. Body aches, chills, jittery/insomnia. I took 4 doses of ibuprofen between 6pm on 1/13 and 6pm on 1/14. Effectiveness of ibuprofen was none to minimal. and symptoms fully returned within 3-4 hours. Symptoms lasted from 6pm on 1/13 until going to sleep at 10pm on 1/14. Woke up on 1/15 at 6am and all symptoms were resolved. I has no symptoms from 1st dose other than pain at the injection site for 24 hours.
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| 38 | 2021-01-14 | fatigue, chills, influenza like illness |
Took second dose shot at 9am on 1/13/21 - by 5pm the same day I started to experience flu like sympt...
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Took second dose shot at 9am on 1/13/21 - by 5pm the same day I started to experience flu like symptoms - no fever but had muscle aches, chills, jittery/restless/insomnia, fatigue - these symptoms continued until 10pm on 1/14. Took four doses of ibuprofen between 6pm on 1/13 through 6pm on 1/14. The ibuprofen was eith ineffective or slightly effective for a short period of time but all symptoms returned within 3-4 hours after taking ibuprofen. All symptoms resolved upon waking at 6am on 1/15/21.
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| 38 | 2021-01-14 | chills | chills, muscle pain, Nausea swelling and redness on injection site |
| 38 | 2021-01-14 | throat irritation |
dry, tight, scratchy throat; dry, tight, scratchy throat; dry, tight, scratchy throat; This is a spo...
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dry, tight, scratchy throat; dry, tight, scratchy throat; dry, tight, scratchy throat; This is a spontaneous report from a contactable pharmacist. A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) intramuscular on 06Jan2021 18:15 (06:15 PM) at a single dose for COVID vaccine. Medical history included anxiety; known allergies to latex, penicillin, wheat, gluten. Concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. It was unknown if the patient received other vaccines within four weeks prior to the COVID vaccine and there were no documented other medications within 2 weeks of vaccination. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). On 06Jan2021 18:15, the patient complained of dry, tight, scratchy throat after receiving vaccine; assessed as non-serious in which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient was monitored and instructed to monitor at home. Treatment was not received for the events. It was unknown if she was diagnosed with COVID-19 prior to vaccination and also unknown if she had COVID-19 tested post vaccination. The outcome of the events was unknown.
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| 38 | 2021-01-14 | fatigue, throat pain, fever |
sore throat; Fatigue; fever; injection site soreness; This is a spontaneous report from a contactabl...
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sore throat; Fatigue; fever; injection site soreness; This is a spontaneous report from a contactable other HCP (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via uknown route of administration, on 06Jan2021 at 11:15 AM (at the age of 38 years old) as a single dose in the right arm for COVID-19 immunization at hospital facility. Relevant medical history included anxiety and depression. The patient has known allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021 evening, the patient experienced injection site soreness at 6:30 PM, fatigue and fever at 7:30 PM. Fatigue and fever were gone by morning. Injection site soreness faded every day. On 08Jan2021, the patient experienced sore throat. No treatment was received for the events injection site soreness, fatigue, fever and sore throat. The outcome of the events injection site soreness, fatigue, fever and sore throat was recovering. The patient was not pregnant at time of vaccination. Since the vaccination, the patient had been tested for COVID-19 via COVID test Nasal Swab on 08Jan2021 with pending result. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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| 38 | 2021-01-15 | discomfort |
Approximately 28 hours after injection I started experiencing intermittent numbness and tingling in ...
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Approximately 28 hours after injection I started experiencing intermittent numbness and tingling in the right hand. At 33 hours post injection developed a deep dull aching pain throughout entire right arm. This worsened, and after 2 more hours intermittent sharp shooting pain down the arm. Pain rated 6 out of 10 intermittently with a constant 3 out of 10 full ache. Difficulty falling asleep due to discomfort and at one point the pain woke me up from sleep. It was resolving by early the next morning, and disappeared by hour 48 post injection. These pains were not inclusive of the soreness and tenderness of the injection site or the muscle pain when lifting the arm. Those symptoms are still present to a minimal extent 54 hours after injection, at the time I am writing this report.
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| 38 | 2021-01-15 | headache | Body aches day after injection. Headache every day for 6 days. |
| 38 | 2021-01-15 | chills, fever | Chills, muscle aches, low grade fever 99.7, whole left arm numbness |
| 38 | 2021-01-15 | fever, headache, fatigue, dizziness, chills | Fever 101 even after Tylenol and Advil Headache Chills Lightheaded Nausea Fatigue Foggy feeling |
| 38 | 2021-01-15 | headache |
Headache, joint pain, back pain. Swelling of joints on left side, which is the side immunization was...
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Headache, joint pain, back pain. Swelling of joints on left side, which is the side immunization was received. Entire upper arm where injection was received is sore all the way to elbow. Elbows and knees hurt like they were hyperextended. These symptoms started at 1000 am the day after the immunization.
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| 38 | 2021-01-15 | headache |
developed headache, myalgia, arthralgia, fatigue, collarbone & back motrin helped 1/13 begain again ...
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developed headache, myalgia, arthralgia, fatigue, collarbone & back motrin helped 1/13 begain again 1/14 redness tangerine size at injection site- motrin 1/15/21 recovered no redness at injection site- aches gone
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| 38 | 2021-01-16 | throat irritation |
Allergic reaction started about 30-35 minutes after injection. First symptom was dry mouth, tickle i...
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Allergic reaction started about 30-35 minutes after injection. First symptom was dry mouth, tickle in throat, and felt like tongue was swelling followed by hot flashes, ?cloudy? brain. My words didn?t want to form although I knew what I wanted to say. I was speaking very slowly. Heart rate was fast.
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| 38 | 2021-01-16 | fatigue, fever, chills |
Covid vx Pfizer Swollen lymph nodes under arm on the same side as injection site. Fatigue, nausea, c...
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Covid vx Pfizer Swollen lymph nodes under arm on the same side as injection site. Fatigue, nausea, chills, body aches, fever
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| 38 | 2021-01-16 | malaise, fever, headache, chills | Fever up to 102.5F, extreme malaise, headache, chills lasted for about 1 day |
| 38 | 2021-01-16 | headache, fever, chills, fatigue |
Fever, chills, tiredness, fatigue, massive headache, body aches, sore and bump on my left arm. These...
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Fever, chills, tiredness, fatigue, massive headache, body aches, sore and bump on my left arm. These have caused me to not come to work for two days. I came back to work 1/16/21, still having headache, soreness on my left arm and feeling tired.
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| 38 | 2021-01-16 | sweating, headache, weakness, fatigue, chills, fever |
Fever, shaking chills >12 hours, drenching sweats, severe myalgias, headache, generalized weakness, ...
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Fever, shaking chills >12 hours, drenching sweats, severe myalgias, headache, generalized weakness, fatigue
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| 38 | 2021-01-16 | weakness, cough, shortness of breath, fatigue, dizziness | Shortness of breath, cough, dizziness, severe air hunger, weakness, fatigue, |
| 38 | 2021-01-18 | weakness, headache, fatigue, dizziness, sweating |
Received dose at 1205 noon on January 15, 2021. I completed the 30 minutes after vaccination due to ...
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Received dose at 1205 noon on January 15, 2021. I completed the 30 minutes after vaccination due to history of food allergies/medication allergies/intolerances and is prescribed epinephrine. After 30 minutes no reaction was seen in return to work, as a healthcare, CMA. At 1500 hrs. became incredibly dizzy, flushed, hot sweats. Sat down with cool window open, facecloth. Legs became tingling and numb, blood pressure was taken at over 130/90, nausea increasing, could not keep eyes open due to dizziness and light, with headache developing. After 30 to 45 minutes of observation from healthcare staff/coworkers became incredibly weak in arms and legs, head became incredibly faint, nausea increased, headache, dizziness, extreme fatigue in regards to wanting to sleep. At which time clinical lead nurse/supervisor brought myself to emergency room department for further evaluation. Was brought into emergency room for further evaluation developed at this time a lump in throat feeling, and was given an IV of Benadryl 25mg and Pepcid 20mg with an hours of observation. Within an hour of observation extreme fatigue tingling numbness and dizziness head decreased. And was discharged from emergency room for vaccine reaction around 20:00. Home with Benadryl 25 mg and Pepcid 20 mg, 3 times daily to treat reaction. After reaction been dealing with headaches and nausea.
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| 38 | 2021-01-19 | throat swelling, throat irritation |
11 minutes after receiving shot, scalp on head started itching, tongue started swelling, area around...
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11 minutes after receiving shot, scalp on head started itching, tongue started swelling, area around tonsils felt like it was swelling. Pt received epi, and lips/tongue/throat continued to swell and itching spread to different parts of face.
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| 38 | 2021-01-19 | throat irritation |
18 minutes after shot patient reported itchy throat similar to what she gets with bee stings. Gave B...
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18 minutes after shot patient reported itchy throat similar to what she gets with bee stings. Gave Benadryl 50mg. BP 115/90 HR 102 Pulse ox 98%. Patients provider was in house and came and assessed her. At 11:28 she recommended a second dose of Benadryl 50mg which was given. Patient much improved. MD will follow up, second shot not recommended by provider at this time.
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| 38 | 2021-01-19 | throat irritation |
Felt hot, flushed, tingling. Then mouth and throat started to burn. Throat felt like closing. Diffic...
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Felt hot, flushed, tingling. Then mouth and throat started to burn. Throat felt like closing. Difficult to swallow water. Able to take Benadryl liquid within 5 minutes of reaction starting and drink water (4 bottles of 16 ounces). 15 minutes later felt returning to normal status. No epinephrine used.
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| 38 | 2021-01-19 | fever, chills, headache | Has a fever, chills, and headache |
| 38 | 2021-01-19 | dizziness | Nausea , dizziness body aches |
| 38 | 2021-01-19 | fatigue, headache |
Nausea.Headache, fatigue, muscle aches,body soreness; and soreness at vaccination site - about 6 hr...
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Nausea.Headache, fatigue, muscle aches,body soreness; and soreness at vaccination site - about 6 hrs later; Two days after vaccine tender to touch left elbow started hurting - later that day I could feel a hard rod-like structure in the elbow on that side > Two days after vaccine - whole arm was hurting. Developed Lymphadenopathy. Fourth day after vaccine: Auxiliary tail of Left breast was hard as well. Called my PCP - warm compresses and Ibuprofen. My arm - I still feel a hard vein in my left arm. The other symptoms went away after 6 or 7 days. (Although nausea stopped after two days.)
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| 38 | 2021-01-19 | malaise |
Patient c/o "flushing" at 1725. Patient offered water. 1730 patient complained "I am not going to l...
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Patient c/o "flushing" at 1725. Patient offered water. 1730 patient complained "I am not going to lie, I am not feeling well." Reported that "the water didn't want to go down" and c/o "throat shutting down." Reports feeling nauseous and started to itch both lower arms. 1737 0.5ml epinephrine administered IM to right deltoid, 911 called. BP 132/82, pulse 92, O2 96% on RA. EMS arrived at 1745 and transported to ER at 1758. Called client morning of 1/15 and reported Benadryl given IV while transported to ER, discharged to home at 2130 on 1/14.
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| 38 | 2021-01-19 | dizziness, fever |
Pregnant at the time of vaccination?: Yes;Pregnant at the time of vaccination?: Yes;Pregnant at the ...
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Pregnant at the time of vaccination?: Yes;Pregnant at the time of vaccination?: Yes;Pregnant at the time of vaccination?: Yes; Dizziness;nausea;fever; This is a spontaneous report from a contactable nurse. This is the maternal report. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 11Jan2021 14:30 at a single dose on right arm for COVID-19 immunization. Medical history included none. No allergies to medications, food, or other products. Concomitant medication included prenatal vitamins. The patient experienced dizziness, nausea, and fever on 12Jan2021 10:00. Treatment was not received for the events. The outcome of the events dizziness, nausea, and fever was recovering. The mother reported she became pregnant while taking bnt162b2 (Pregnant at the time of vaccination?: Yes). The events were assessed as non-serious. The mother was 24 Weeks (gestational period) pregnant at the onset of the event. The mother was due to deliver on 03May2021. Last menstrual date: 24Jul2020. Patient did not receive any other vaccines. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 38 | 2021-01-19 | headache, dizziness |
Systemic: Headache-Medium, Systemic: Dizziness accompanied by elevated blood pressure (175/111), blo...
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Systemic: Headache-Medium, Systemic: Dizziness accompanied by elevated blood pressure (175/111), blood pressure dropped within 10 minutes, most likely induced by anxiety-Severe
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| 38 | 2021-01-19 | fatigue, somnolence, chills, sweating |
When I got up at 0530 yesterday (1/19) my right arm was so sore I couldn't lift it. I got to work at...
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When I got up at 0530 yesterday (1/19) my right arm was so sore I couldn't lift it. I got to work at 0700 and felt really drained and tired. I fell asleep without realizing it at some point and a coworker saw me and woke me up at 0930. I attended a lecture at 1000 and started feeling chills, aches, and was sweating. I tried to take notes but couldn't remember how to spell a lot of basic words and couldn't get my brain to focus. My boss sent me home at 1145. I was driving home and when I got off the interstate I couldn't remember which way to turn at the light off the exit. I had to pull up a navigation app on my phone to remember how to get home. When I got home I took my temperature and it was 98.5F. I slept for 3 hours, picked my kids up from school, and then slept for another 2 hours. I took my temperature at 1900 and it was 98.5F still. My chills and aches had lessened but not disappeared by the time I went to bed at 2100, but by the time my alarm went off at 0530 this morning I felt completely back to normal.
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| 38 | 2021-01-19 | fever, fatigue |
Woke up at 7 am on the 19, Feeling extreme fatigue, body aches, low grade temp. I called the virtual...
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Woke up at 7 am on the 19, Feeling extreme fatigue, body aches, low grade temp. I called the virtual IU Health line to report symptoms. I spent all day in bed till symptoms started to subside which was around 4:30pm 01/19/2021. I was completely symptom free by 01/20/2021 at 0930 am.
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| 38 | 2021-01-19 | fatigue, headache, somnolence |
general fatigue (sleepiness), muscle aches, headache, left arm sore - 2-3 days and then the symptoms...
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general fatigue (sleepiness), muscle aches, headache, left arm sore - 2-3 days and then the symptoms resolved
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| 38 | 2021-01-19 | fatigue, body temperature increased, headache, chills | mild headaches, chills, body ache, severe fatigue, mild nausea. temp 99.7 |
| 38 | 2021-01-21 | headache, sweating, body temperature increased |
12 hours after my first dose (1/19) I woke up with a high temperature, extreme body aches, sweating,...
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12 hours after my first dose (1/19) I woke up with a high temperature, extreme body aches, sweating, headache and nausea. These symptoms continued until the following morning (1/21) and then begin to subside. It's now 1/22 and the symptoms are coming back. I've taken Tylenol and ibuprofen, but I am still experiences headache, body aches, upset stomach and brain fog.
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| 38 | 2021-01-21 | dizziness, headache |
About 9 am on 1-21-2021 started to ?feel off?, between this time and 11am I would get light headed ...
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About 9 am on 1-21-2021 started to ?feel off?, between this time and 11am I would get light headed at random. At 11am I started to see ?black floaters? and developed a slight headache. Coworker (another ICU RN) took blood pressure: 234/148 and tachycardia. Was made to rest while arrangements could be arranged and given 4 chewable baby aspirin. Was then sent to urgent care.
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| 38 | 2021-01-21 | fatigue, headache, chills, nasal congestion | Chills, headache, body aches , tiredness and stuff nose |
| 38 | 2021-01-21 | headache, runny nose | Had a head ache 8 days, Two or three days later diarrhea 1 day , running noise 1 days . |
| 38 | 2021-01-21 | fever, fatigue, chills | Muscle ache, fever, chills, nausea, fatigue, sore arm. |
| 38 | 2021-01-21 | headache | Neck Pain, throbbing headache, muscle pain everywhere |
| 38 | 2021-01-21 | chills, shortness of breath, fatigue |
Next day after of tired, fatigue, muscle ache, chills, arm ache, shortness of break and took a tyle...
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Next day after of tired, fatigue, muscle ache, chills, arm ache, shortness of break and took a tylenol. 01/13/2021 walk -in clinic and high heart rate and shortness of breath and fatigue. Covid -19 positive 12/04/2020
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| 38 | 2021-01-24 | dizziness |
Dizziness; Tachycardia; This is a spontaneous report from a contactable other HCP. This other HCP re...
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Dizziness; Tachycardia; This is a spontaneous report from a contactable other HCP. This other HCP reported for self that the 38-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID-19 Vaccine, Lot#: EL0140, Expiry Date: 31Mar2021), via an unspecified route of administration on 05Jan2021 13:15 on Deltoid, Right at single dose for covid-19 immunisation. Medical history included she did get a monthly allergy injection about 3-4 weeks prior to the COVID-19 Vaccine. She said she did not have any reaction to the allergy shot, clarifying she has always done well with her allergy shots. Concomitant medications were none. She said she got dizzy for about 30 minutes afterwards, and then was all better. Caller asked if Pfizer has any guidance on how she should proceed with the second COVID-19 Vaccine dose. Caller was advised she would be transferred to Pfizer Medical Information for further assistance. Reported she got really dizzy approximately 10 minutes after receiving the COVID-19 Vaccine, and the dizziness lasted for about 30 minutes after that. She said the dizziness completely resolved. Reported she also got a little tachy (clarified as tachycardia) during the time period she was dizzy. She said she wasn't sure if she became tachycardic because she was worried when she became dizzy. She said the tachycardia resolved with the dizziness. No treatment was received. The events stared from 05Jan2021 and considered as Medically significant. The outcome of the events was recovered on 05Jan2021. Vaccination Facility Type was Hospital. No Vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE was require a visit to: Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. Relevant tests was none.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of dizziness and tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 38 | 2021-01-24 | chills, fever, headache |
Pain in the body and headache, Fever, inflammation of the right axillary ganglion and chills. Sympto...
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Pain in the body and headache, Fever, inflammation of the right axillary ganglion and chills. Symptoms presented on 1/21/2021 and continued on 1/22/2021. Tylenol was taken continuously every four hours. On 1/23/2021 the symptoms were alleviated.
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| 38 | 2021-01-24 | chills, runny nose, body temperature increased |
temp of 100.4, chills, diarrhea, muscle aches, runny nose--symptoms resolved 1/20, also had a covid ...
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temp of 100.4, chills, diarrhea, muscle aches, runny nose--symptoms resolved 1/20, also had a covid exposure so will get tested in 5-7 days post exposure
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| 38 | 2021-01-25 | fever, shortness of breath |
AT 2130 ON 1/20/21 DEVELOPED SHAKES, THAT PROGRESSED TO 'CONVULSING. DEVELOPED FEVER OF 104.3. SEVER...
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AT 2130 ON 1/20/21 DEVELOPED SHAKES, THAT PROGRESSED TO 'CONVULSING. DEVELOPED FEVER OF 104.3. SEVERE ARM, NECK, AND CHEST PAIN. SHORTNESS OF BREATH THAT IMPROVED OVER TIME. ON 1/23/21 COMPLAINED OF SEVERE ITCHING OVER ENTIRE BODY
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| 38 | 2021-01-25 | fever, headache, fatigue |
On the afternoon of 1/23/21, I began having achiness and fatigue, which lasted through 1/26/21. Head...
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On the afternoon of 1/23/21, I began having achiness and fatigue, which lasted through 1/26/21. Headache, nausea, and fever ranging from 99.1-100.9 also experienced with onset on 1/24/21 through 1/25/21.
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| 38 | 2021-01-25 | headache |
This is a spontaneous report from a contactable consumer. A 38-year-old female patient received BNT1...
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This is a spontaneous report from a contactable consumer. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if the patient had COVID prior to vaccination. It was unknown if the patient received other vaccines in four weeks or other medications in 2 weeks. The patient experienced muscle aches and headache on 08Jan2021. It was reported that the patient was complaining of continuous muscle aches and headache four days after receiving the vaccination (as reported). The patient has not been tested for COVID post vaccination. The outcome of the events was not recovered.
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| 38 | 2021-01-25 | fever | fever, body aches, neurological tremors to leg |
| 38 | 2021-01-25 | chills, headache, dizziness |
really big sharp headache; lots of vowel movements (Diarrhea); Chills; dizziness; This is a spontane...
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really big sharp headache; lots of vowel movements (Diarrhea); Chills; dizziness; This is a spontaneous report from a contactable healthcare professional. A 38-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (right arm, second dose) from 12Jan2021 17:00 to 12Jan2021 17:00 at a single dose for COVID-19 vaccination. Medical history included UTI. Concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020 (first dose). It was reported by the patient that she was awaken in the middle of the night because of a really big sharp headache also with lots of bowel movements (Diarrhea). The patient also had Chills and dizziness; all on 13Jan2021. There was no treatment for the events. The outcome of the events was not recovered. Information on the Lot/batch number has been requested.
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| 38 | 2021-01-26 | throat pain |
At the vaccination day only soreness at the injection site. I started feeling bad on 12/27/20 with a...
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At the vaccination day only soreness at the injection site. I started feeling bad on 12/27/20 with a sore throat. Monday I had a bit of sinus congestion and Tuesday 12/29/20 no sense of smell or taste. I was tested that day on 12/29/20 and was positive.
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| 38 | 2021-01-26 | dizziness |
Dizziness and lightheadedness. Given juice and crackers; had not eaten since breakfast. Also given ...
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Dizziness and lightheadedness. Given juice and crackers; had not eaten since breakfast. Also given water. Symptoms resolved. Monitored for 30 minutes.
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| 38 | 2021-01-26 | chills, fever |
Expected side effects were noticed roughly 15hrs after vaccine was received. At approximately 18hrs ...
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Expected side effects were noticed roughly 15hrs after vaccine was received. At approximately 18hrs post vaccination elevated temperature was documented. My temperature continued to increase throughout the day. By 10pm on January 11th all symptoms experienced post vaccine had resolved. Below is a timeline of events as well as measures taken during recovery phase. - Severe chills associated with elevated temperature. Highest documented temperature was 102.1 roughly 24hrs post vaccination. Severe muscle aches in bilateral lower extremities (during elevated temp only). Moderate bilateral hip pain (during elevated temp as well). No were antipyretics taken during this event. Oral water intake increased during these hours.
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| 38 | 2021-01-26 | fever, chills |
G3P1011 at 19wks EGA given Pfizer Covid-19 vaccine 17 days after first in series. Within 24 hours of...
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G3P1011 at 19wks EGA given Pfizer Covid-19 vaccine 17 days after first in series. Within 24 hours of administration, developed fevers exceeding 104 degrees (104.7 max, tympanic), tachycardia to 130s, rigors with fevers not responding to maximal doses of oral acetaminophen and ibuprofen, requiring hospital admission for IV fluids and IV antipyretics and anti-inflammatory agents.
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| 38 | 2021-01-26 | migraine, headache, shortness of breath, chills, cough |
Headache, nausea, general soreness through out body, chills, migraine, difficulty breathing with non...
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Headache, nausea, general soreness through out body, chills, migraine, difficulty breathing with non-productive cough (on day 2). treated with Tylenol, IBU, and routine migraine medication, hydration.
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| 38 | 2021-01-26 | migraine, headache | Headache/migraine, lasted 12-15 hours, took ibuprofen |
| 38 | 2021-01-26 | headache, migraine |
Nausea; vomiting; Metallic taste; Headache; migraine; didn't have an appetite; lost taste, lost the ...
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Nausea; vomiting; Metallic taste; Headache; migraine; didn't have an appetite; lost taste, lost the sense of taste; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported a 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176) via unspecified route single dose for COVID-19 immunization on 08Jan2021, 10 am, at 38-year-old. Medical history was not reported. Concomitant medication included: celecoxib (CELEXA) 10 mg for an anti-depressant; alprazolam (XANAX) 0.25mg three times a day. Once the patient took that second vaccine, she had the metallic taste and had some headache and migraine at that time (08Jan2021). When the patient got the vaccine, within one minute, she started getting her usual migraine on the right side of head (08Jan2021), that was pretty much instantly. She didn't have an appetite (Jan2021), she only vomited when she ate. She had nausea and vomiting, it was about 2 o'clock that afternoon (08Jan2021, 2 pm). Every time she ate, she vomited and lost taste, lost the sense of taste. The patient was still nauseated (Hence, ongoing checked for nausea) and she hadn't tasted anything. She hadn't drink or ate anything yet this morning but last night her taste was starting to come back. But she still couldn't identify something. No treatment received. Action taken for BNT162B2 was not applicable. Outcome of the event nausea was not resolved, outcome of the other events was unknown.
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| 38 | 2021-01-26 | headache, dizziness, fatigue |
Shot recieved Wednesday. By Wednesday night, I had a headache (forehead and back of neck) and fatig...
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Shot recieved Wednesday. By Wednesday night, I had a headache (forehead and back of neck) and fatigue. Friday I became dizzy, and had 2 near fainting spells (this included dizziness, weak muscles, and slight loss of sight). I became achy (back and shoulders) and my headache continued. These dizzy spells and headaches have continued for 6 days. The dizziness is starting to subside, however the headache and fatigue remains.
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| 38 | 2021-01-26 | throat swelling |
Within 2 minutes of receiving vaccine, patient reported experiencing throat swelling, face and lip t...
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Within 2 minutes of receiving vaccine, patient reported experiencing throat swelling, face and lip tingling. Patient was administered diphenhydramine PO while in clinic. At this time, patient declined to be seen in the ED and was released from clinic after additional monitoring. Patient received a course of prednisone from another physician later that day. 2 days later the patient began experiencing severe abdominal pain and was seen in the ED. Labs, right upper quadrant ultrasound, and abdominal CT were within normal limits and was determined that symptoms were likely still part of COVID vaccine anaphylactic reaction. The patient was evaluated by the acute care surgery service who did not find anything concerning and was discharged home from the ED with return precautions and instructions to follow-up with primary physician. The patient follow-up with PCP and was continued on a 5 day course of steroids. The patient will not receive a second vaccine dose at this time and was referred to see an allergist for further testing.
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| 38 | 2021-01-26 | headache, fatigue |
headache; Right arm pain; fatigue; myalgia; This is a spontaneous report from a contactable healthca...
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headache; Right arm pain; fatigue; myalgia; This is a spontaneous report from a contactable healthcare professional (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration on right arm on 12Jan2021 08:30 (dose number 2) at a single dose for COVID-19 immunization. Medical history included allergic rhinitis. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks and no other medication in two weeks. There were no concomitant medications. The patient previously took dexilant and had known allergies to the medication. The patient experienced right arm pain, fatigue, myalgia and headache on 12Jan2021 15:00. Treatment for the events included Advil 200 mg. The patient was tested for COVID (Nasal Swab) on 19Nov2020 which showed negative result. The outcome of the events was not recovered.
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| 38 | 2021-01-26 | malaise, discomfort, shortness of breath, dizziness, sweating |
hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a s...
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hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 38-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand= Pfizer/Biontech, lot/batch number and expiry date were not reported), via an unspecified route of administration in the right arm on 11Jan2021 14:45 at SINGLE DOSE for Covid-19 vaccination. She received the vaccine in a facility. Medical history included gastrooesophageal reflux disease. No other vaccine in four weeks. Concomitant medications included ergocalciferol (VIT D) and lansoprazole (PREVACID). On 11Jan2021, within about 10 minutes of getting the vaccine she reported that her heart began to race and she became sweaty and uncomfortable. After another 5 minutes or so she began to have difficulty breathing as her chest and throat felt very tight and restricted. She also became lightheaded. Her heart rate was over 100, then dropped into the 70s, then shot back up over 100. Her face had a weird sensation as well. She was given Benadryl first and then epinephrine and had to go to the emergency room via ambulance for observation. She was released after an hour and had to take Benadryl every 6 hours for the next 24 hrs and diagnosed with an allergic reaction. On 12Jan2021, she had a hot flash upon waking up and felt generally under the weather all day. Her arm was very sore at the injection site. She missed a day of work due to the whole ordeal. On 13Jan2021, she felt more normal but still have some tightness in her chest with a fluttering feeling. The outcome of event diagnosed with an allergic reaction was not recovered; for other events was recovered. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between event allergic reaction to vaccine and BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 38 | 2021-01-26 | fever, nasal congestion |
intense chest pain; nasal congestion; Fever; body ache; This is a spontaneous report from a contacta...
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intense chest pain; nasal congestion; Fever; body ache; This is a spontaneous report from a contactable physician. A 38-year-old not pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at left arm on 06Jan2021 14:00 at single dose for COVID-19 immunization. Patient had Covid prior vaccination. There were no concomitant medications. No other medications in two weeks. No other vaccine in four weeks. On 07Jan2021, The patient experienced fever and body ache for the first 2 days. On the 3rd day (19Jan2021) experienced intense chest pain and nasal congestion. she needed to go to Emergency Room where she stayed for 4 hours, and performed Thorax CT. No treatment received. The outcome of events was recovering.; Sender's Comments: Based on a compatible temporal relationship, causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 38 | 2021-01-26 | fatigue, chills, dizziness |
severe dizziness; disorientation; Tired; muscle aches; L ear pain; chills; This is a spontaneous rep...
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severe dizziness; disorientation; Tired; muscle aches; L ear pain; chills; This is a spontaneous report from a contactable Other HCP (patient). A 38-year-old female (pregnant: No) patient received 1st dose of BNT162B2 (COVID vaccine, lot number= EK9231) on 11Jan2021 12:30 PM on Left arm for covid-19 immunization. Medical history and concomitant drug were not reported. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Patient experienced severe dizziness, disorientation, unable to finish any tasks. Tired, some muscle aches, L ear pain and chills (no fever) on 11Jan2021 01:00 PM. No treatment. Outcome of the event was Recovered/Resolved with Sequel. No further information is expected. Information on the Batch/Lot number has been obtained.
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| 38 | 2021-01-27 | migraine |
Complex migraine with neurological symptoms: numbness to R upper extremity, trouble speaking. Pati...
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Complex migraine with neurological symptoms: numbness to R upper extremity, trouble speaking. Patient presented to Emergency Dept. Sxs resolved in one hour.
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| 38 | 2021-01-27 | malaise, chills |
Intense abdominal cramps; chronic diarrhea; chills; feeling unwell; soreness in injection site; musc...
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Intense abdominal cramps; chronic diarrhea; chills; feeling unwell; soreness in injection site; muscle aches; This is a spontaneous report from a contactable other healthcare professional (reported for self). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular (right arm) on 06Jan2021 at single dose for Covid-19 immunization. The patient's medical history included sciatica and Allergy: sulphur drugs. Concomitant medication included Multivitamins (unspecified). The patient previously took aspirin [acetylsalicylic acid] and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that initially after the vaccine (Jan2021; unspecified date), she experienced soreness in injection site and muscles aches, but these symptoms were mild. On 11Jan2021, the patient experienced intense abdominal cramps, chronic diarrhea, muscle aches, chills, and feeling unwell (also reported that these symptoms developed 5 days after vaccine). The adverse events resulted in Doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse events. The patient has been tested for COVID-19 post vaccination: Covid test type post vaccination was Nasal Swab, Covid test name post vaccination=Pcr; Covid test date=13Jan2021; Covid test result=Negative. The outcome of events was not recovered.
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| 38 | 2021-01-28 | fatigue, headache, chills |
Temperature; chills; body aches; headaches; nausea; vomiting; diarrhea; fatigue; stomach pains; This...
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Temperature; chills; body aches; headaches; nausea; vomiting; diarrhea; fatigue; stomach pains; This is a spontaneous report from a contactable other healthcare professional (patient). This 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3249) via an unspecified route of administration in the left arm on 11Jan2021 at 10:45 at single dose for COVID-19 immunisation. Relevant medical history included penicillin allergy and allergy to clindamycin and doxycycline. Concomitant medications were not reported. The patient had a nasal swab COVID test result positive on 01Jan2021 after the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJ1685) administered on 21Dec2020 in the left arm for COVID-19 immunization. On 11Jan2021 at 21:00, the patient experienced temperature, chills, body aches, headaches, nausea, vomiting, diarrhea, fatigue and stomach pains. The patient underwent a Nasal Swab on 11Jan2021 which was positive. The patient did not receive corrective treatments. The patient had not recovered from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021030273 same reporter/patient, different dose of COVID-19 vaccine/event
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| 38 | 2021-01-28 | headache |
The first round of the vaccine she only had a super mild sore arm and a slight headache.; The first ...
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The first round of the vaccine she only had a super mild sore arm and a slight headache.; The first round of the vaccine she only had a super mild sore arm and a slight headache.; sore; This is a spontaneous report from a contactable nurse. A 38-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284, expiry date: 30Apr2021), intramuscularly on 28Dec2020 at SINGLE DOSE at left deltoid for covid-19 immunisation. Medical history included ongoing pernicious anaemia, a b12 deficiency. She gives herself B12 shots. She was diagnosed 2-3 years ago. She also had a Myomectomy, 15 cm uterine fibroid , removed this past summer. Concomitant medication included ongoing cyanocobalamin (B12 [CYANOCOBALAMIN]) for pernicious anemia. The first round of the vaccine she only had a super mild sore arm and a slight headache. She was a little suspicious because of the headache after the first one. She hasn't been around anyone in a couple of weeks. She has been working from home. She has not been exposed to people. She keeps feeling like she needs to stretch because she is sore. The patient underwent lab tests and procedures which included COVID 19 test on an unspecified date: negative, COVID-19 antibody test on an Unspecified date, Result: negative. The outcome of the events was unknown.
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| 38 | 2021-01-28 | headache, cold sweat, chills |
nasty headache; felt hot; Shivers; achy; Nauseous; eyesight/ felt like she was straining; sensitivit...
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nasty headache; felt hot; Shivers; achy; Nauseous; eyesight/ felt like she was straining; sensitivity to light; eyeballs felt sore; cold sweats; when she talked, she felt like she had to close her eyes because of pressure; arm was hurting really bad; received the 2nd vaccine yesterday/ date of the first vaccine was 28Dec2020; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: 30Apr2021), intramuscularly on the left arm, deltoid on 14Jan2021 15:30 to 14Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included ongoing pernicious anaemia, a B12 deficiency diagnosed 2-3 years ago (she gave herself B12 shots and she cannot convert B12 through her food), and myomectomy (15 cm uterine fibroid, removed this past summer). Concomitant medication included ongoing cyanocobalamin (B12) for pernicious anemia. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: 30Apr2021), intramuscularly on the left arm, deltoid on 28Dec2020 at a single dose for COVID-19 immunization; and a flu shot (the MA gave it in the back of her arm, it was pretty significant). The patient was a nurse and informed that she received the second COVID vaccine the day before report (14Jan2021). She woke up on the day of report on 15Jan2021 03:00 with a nasty headache, she felt hot, had the creepy crawly shivers, was achy and when she talked, she felt like she had to close her eyes because of pressure, and she was nauseous. She figured this was probably normal but she couldn't get a hold of her doctor and the hospital she worked at did not know what to tell her. She was wondering if she can take Tylenol or ibuprofen and has even thought about drinking caffeine, that it might help her headache. She didn't have a prescribing doctor as she got it at work. The first round of the vaccine she only had a super mild sore arm and a slight headache. She received the second vaccine at 3:30pm and then went to bed when she got home. She woke herself up at 3 am because her arm was hurting really bad. She started feeling like she couldn't keep her legs still. She felt hot, achy, and was shivering. She hasn't taken her temperature. When she woke up at 3 am she got on her phone, and her eyesight felt like she couldn't quite focus. It wasn't bad, but she felt like she was straining. Then her head started hurting at 5-7 am. She was very sensitive to light. She woke up and couldn't go back to sleep. She had cold sweats, and was shivering. Every time she stood up, she was chattering. She felt achy almost like growing pains. She woke up with the arm pain, and then 10-15 minutes later, she started feeling that creepy crawly feeling. She got up and the cool fan hit her, and she realized how bad she was shivering. The shivering intensified at times but hasn't gotten worse. She had just called employee health and realized that when her eyes were open when she was talking was when she felt nauseated. She has noticed the nausea in the past half hour. She did not know if it was related to the headache or what. She had to cover her eyes, her eyeballs felt sore. When she talked with her eyes open, she felt a little queasy. She was just straining to see. Her vision was not blurry but she can tell she was straining. She did not know if it was because of the headache and nausea. When she got out of bed, the cold fan did not feel cold but it made her shiver. She was a nurse was trying to be socially responsible as she did not want to get COVID. She was a little suspicious because of the headache after the first one. She hasn't been around anyone in a couple of weeks and had been working from home. She has not been exposed to people. She kept feeling like she needed to stretch because she was sore. The patient was tested for COVID pre-surgery (myomectomy) and was negative. She was also tested for COVID antibodies and she did not have any. She was vaccinated at a hospital facility. Patient received no other vaccines on that day. The adverse events did not require any visit to the emergency room or physician office. Patient did not receive prior vaccines in the previous 4 weeks. Outcome of the events cold sweat and "tested for COVID antibodies and she did not have any" was unknown, nasty headache was reported as worsened (not recovered), and the remaining events was not recovered. The reporter considered the events serious due to medically significant events and related to the suspect drug.; Sender's Comments: Based on the information currently available, a possible contributory role of BNT162B2 vaccine in the development of the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 38 | 2021-01-31 | fever, fatigue, headache, sweating, influenza like illness, dizziness, cough, runny nose, chills, throat pain |
Day 1 (day of vaccination): Within 15 minutes of receiving the jab i experienced heart palpitations,...
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Day 1 (day of vaccination): Within 15 minutes of receiving the jab i experienced heart palpitations, fever, dizziness, a dry mouth/throat and heat in my head/upper body. After being discharged from recovery an hour later i returned home but felt very anxious all night. Heart palpitations continued on and off. Day 2: Severe cramp/pain started in my arm, neck and shoulders. Headache. Sweating. Days 3 & 4: Flu symptoms; headache, shivers/fever, runny nose, sore throat, cough, severe muscle and joint pain. Skin was so sensitive to touch i could not wash. Muscles hurt so much i could not move around. Extreme fatigue. Days 5 & 6: Cold symptoms started to resolve. Muscle and joint pain still very severe - difficulty walking/moving around, stiffness and aches in every part of my body. Extreme fatigue. Days 7, 8 & 9: Cold symptoms gone. Muscle and joint pain still severe. Extreme fatigue. Day 10: Pain in muscles started to resolve but not in joints. Fatigue still present. Day 11: Fatigue starting to resolve, joints still very sore.
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| 38 | 2021-01-31 | chills, fatigue, headache, migraine, fever, runny nose, somnolence |
Vomiting for 12 hours, diarrhea for 24 hours, headache/migraines for 7 days, body aches for 7 days, ...
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Vomiting for 12 hours, diarrhea for 24 hours, headache/migraines for 7 days, body aches for 7 days, extreme fatigue, slept for 28 hours at one time, no appetite, runny nose, fever, chills,.
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| 38 | 2021-02-03 | shortness of breath, cough |
Bad cough; Trouble breathing; Tingling around mouth; Numbness in jaw and neck; Shaking; Red face and...
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Bad cough; Trouble breathing; Tingling around mouth; Numbness in jaw and neck; Shaking; Red face and chest; Slight itching; This is a spontaneous report from a contactable healthcare professional (the patient). A 38-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular in the left arm on 18Jan2021 at 10:30 (at the age of 38-years-old) as a single dose for Covid-19 immunization. Medical history was not reported. The patient was allergic to penicillin. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1685) on 28Dec2020 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ALERTEC), both for unknown indication from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Jan2021 at 11:00, the patient experienced bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching. Treatment was given when seen by paramedics with an emergency room visit which included a second dose of allergy medication. The clinical outcome of the events bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The reported events were likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), considering the plausible temporal relationship and clinical course of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 38 | 2021-02-04 | somnolence |
face started itching; throat was getting dry; face was starting too itch and be red; hives after sec...
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face started itching; throat was getting dry; face was starting too itch and be red; hives after second dose of vaccine; This is a spontaneous report from a contactable Other HCP reported for herself. This 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL1283, Expiry Date: 30Apr2021), via an unspecified route of administration on 18Jan2021 06:45 at single dose injected into left arm for COVID-19 immunisation. Medical history included asthma from 2010. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT EJ1685, EXP 31Mar2021.) on 18Jan2021 at 04:00PM, injected into her right arm for COVID-19 immunisation, uses salbutamol (ALBUTEROL, NDC: 6699301968, LOT: VE7L, EXP: Nov2021) inhaler as needed for asthma and took inhaled steroids, but nothing recent. The patient got the second dose of the vaccine at 06:45AM, and the hives began on the 21Jan2021, she noticed them about 06:20AM and she had to be at work at 07:00AM. She said she treated that with diphenhydramine hydrochloride (BENADRYL, 25mg LOT: P120108. EXP May2022, UPC: 193968051518) because her face started itching and her throat was getting dry, so she took BENADRYL 25mg this morning about 06:40AM. She says she took one dose of this by mouth, because it seems to make her sleepy and she had to work. She says she got to work and started working, and her face was starting too itch and be red, and her throat was super dry, this was at 07:20AM, so she took prednisone (NDC: 20603-5338-31, LOT 8675217, EXP Dec2020) 60mg by mouth. She says this was expired, but she still took it, it is in a dose pack that has a box that says distributed by (Company name). She says she took Prednisone 60mg, one time today by mouth. She says she has asthma so she keeps a prescription of Prednisone at home that her doctor writes so she can have it, she says with asthma she keeps Prednisone around. She says she also applied equate Hydrocortisone cream 1% (LOT: 0JT0306, EXP Aug2022) that she got over the counter to the hives topically. She says that the label for that says underneath anti-itch it says intensive healing that it is mixed with vitamins, chamomile and Vitamins A, C, and E. Equate Hydrocortisone cream 1% UPC: Unknown, the tube has a barcode with no number, it did have a box that she did throw away. She thought hives was medically significant, but it is not getting worse, it is worrisome, but she is improving with the medicine she used for treatment. The outcome of hives was recovering. The outcome of other events was unknown.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 38 | 2021-02-04 | shortness of breath, headache, throat irritation |
feeling some increasing shortness of breath; feeling some increasing shortness of breath; scratchy t...
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feeling some increasing shortness of breath; feeling some increasing shortness of breath; scratchy throat; some swelling in her bilateral periorbital area; have a mild headache; This is a spontaneous report from a contactable Pharmacist. A 38-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, lot # EL3302) intramuscular at single dose at right arm on 14Jan2021 11:30 for Covid-19 immunisation, administered at hospital. Medical history included, chronic headaches and vertigo, depression, type 2 diabetes mellitus (DMT2), hypertension, vitamin d deficiency, sleep apnoea syndrome (OSA), chronic pain, psoriatic arthropathy, allergies: ACE inhibtors, gabapentin, lisinopril, Lyrica, milk products, nuts. Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included: amlodipine (manufacturer unknown) 2.5mg, apremilast (manufacturer unknown), bupropion (manufacturer unknown) 150mg bid, calcipotriene (manufacturer unknown) topical, carvedilol (manufacturer unknown) 12.5mg bid, ergocalciferol (VIT D, manufacturer unknown) 1000 units, duloxetine (manufacturer unknown) 20mg bid, dicyclomine (manufacturer unknown) 20mg qid, losartan (manufacturer unknown) 50mg qday. The patient previously received the 1st dose of bnt162b2 (BNT162B2, lot # EL1284) intramuscular at single dose at left arm on 23Dec2020 12:30 PM for Covid-19 immunisation, administered at hospital. Patient denied any allergic reaction to the initial dose of Covid vaccine. No other vaccine has been received in 4 weeks. On 14Jan2021 12:00 PM after vaccination, she has being monitored for the mandatory 15-30 minute period, when she started feeling some increasing shortness of breath, scratchy throat, some swelling in her bilateral periorbital area. She was then taken to the ED for further evaluation. Patient denied any allergic reaction to the initial Covid vaccine 3 weeks before. She denied any abdominal pain, diarrhea, nausea, vomiting, chest pain, shortness of breath. She had a mild headache. In ED, patient received treatment with diphenhydramine 25mg IV, epinephrine 0.3mg IM, famotidine 20mg IV and dexamethasone 10mg IV, and LR 1,000mL bolus @ 1228, ketorolac 15mg @1312, ondansetron 4mg @1312. Patient monitored and discharged at 1530. Post vaccination, the patient has been tested with nasal swab for COVID-19 and resulted negative on 15Jan2021. Therapeutic measures were taken as a result of events. The outcome of recovered in Jan2021.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association
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| 38 | 2021-02-07 | headache, chills, somnolence, fever |
Feverish, chills, headaches, nausea, dry mouth, and sleepiness the day after the Vaccine was taken. ...
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Feverish, chills, headaches, nausea, dry mouth, and sleepiness the day after the Vaccine was taken. Started out slowly late morning around 9am and got worse by the afternoon. Took Motrin to relieve symptoms and slept. The next day felt better but in the evening on 2/5/21 felt itchy starting from arms and neck. Then after about 10 min of itchiness in that area and started itchiness down to my stomach and legs. I took allergy medication prescribed by my physician: Cetirizine HCL 10mg tablet (1 tablet). No issues after that. Had some issue with the itchiness from the first dose around the 3rd-5th day after the first vaccine was given. Didn't take any allergy medications and had a tiny bit of dark circular spots on limps and torso but wasn't severe. Thought that was from something I ate, or clothes detergent, etc. so shrugged it off.
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| 38 | 2021-02-21 | pneumonia, weakness |
2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness,...
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2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM
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| 38 | 2021-02-21 | chills, fever, throat pain, headache, fatigue |
5:30 pm started with mild Headache. Progressed to nausea and more prnounced HA. At 7:30 began havin...
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5:30 pm started with mild Headache. Progressed to nausea and more prnounced HA. At 7:30 began having chills and fever. Slept all day. Awoke with HA and fatigue. My heart felt like it was beating fast with physical activity. Then developed a sorethroat.,
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| 38 | 2021-02-21 | chills, fatigue, shortness of breath | Chills, fatigue, hallucinations, shortness of breath, chest pain, and body aches |
| 38 | 2021-02-21 | headache |
I began having headaches nightly 2 nights after my second dose. On 2/7 my blood pressure was about 1...
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I began having headaches nightly 2 nights after my second dose. On 2/7 my blood pressure was about 135/90. On 2/9 my blood pressure was 150/90 or 95 and then it increased by the time I went to my doctor?s office that afternoon. I had severe pre eclampsia on 2/8 and was induced and delivered 2/9 with a 34 week old baby. She had an infection and pulmonary hemorrhage.
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| 38 | 2021-02-21 | headache | burning in arm, and headache |
| 38 | 2021-02-22 | headache |
I had headache and nausea for the rest of the day that I got the vaccine. After that I was fine. As...
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I had headache and nausea for the rest of the day that I got the vaccine. After that I was fine. As a result I didn't feel like doing anything but laying down. Also as expected, I had pain at the injection site.
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| 38 | 2021-02-22 | headache, fatigue |
On 1/7/2021 around 10am I had normal arm pain, my right arm started swelling, my skin turned really ...
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On 1/7/2021 around 10am I had normal arm pain, my right arm started swelling, my skin turned really read, red hard rash, my face turned very red, pain on my shoulder & neck, and very bad headaches, my work send me o the emergency room, & also I had hard time seeing everything was very hard to see. I felt very nauseas I couldn't eat for the first couple of days, a lot of body aches & felt very fatigue. In the emergency room they prescribed me Trimodal & Zofran. I had to miss 4 days of work it lasted about 7 days the first 4 days my symptoms were sever but by the 5th day it was getting better.
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| 38 | 2021-02-22 | headache, fever |
On the next day the patient started to have fevers, headaches, couldn't stand up. In the second and ...
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On the next day the patient started to have fevers, headaches, couldn't stand up. In the second and third day after the vaccination the patient started to feel joint pain, tingling sensation.
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| 38 | 2021-02-22 | malaise, chills, headache, fatigue |
Sore arm, swollen eye (lump under the skin and visible in the rim of the eye, fatigue, malaise, head...
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Sore arm, swollen eye (lump under the skin and visible in the rim of the eye, fatigue, malaise, headaches, chills, diarrhea. All recovered other than the sore eye.
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| 38 | 2021-02-22 | headache, malaise, head discomfort |
Within 30 minutes, I started to have a very mild headache. It felt like a pressure headache. I took ...
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Within 30 minutes, I started to have a very mild headache. It felt like a pressure headache. I took Motrin. About 6 hours later that was gone. That night, about 8 hours after vaccine, I began to have muscle aches - whole body. I was very sore. I went to bed. Next day, I had severe joint and muscle aches and pains. The Motrin did not help that. Ice did not help, heat did not help and rest did not help. No headache. I wasn't red in face etc. Over the next week, I the muscle aches and joint aches were varying between moderate to severe. Some days it did restrict my activity completely. It started to get better week two - but still moderate to severe. I had some abdominal pain on upper left side and my right side (upper, as well) The upper right side pain would go away with ice but the upper left side wasn't helped with that. The only thing in those two weeks that helped was Celebrex (Motrin stopped helping). After two weeks - around 2/5/2021, I saw my Dr - a virtual visit. He told me to double up on the dose of Celebrex to help with muscle aches, joint aches and right side abdominal pain. Heart palpitations - irregular heartbeat. On 2/7/2021, I took a test for COVID and it was negative. The joint and muscle aches were moderate to mild the third week. There was no more abdominal pain in third week. Week 4 - mild joint and muscle aches - only a few days that week and that was it. Last week was the first week where I had a few days that were fine. And this week, I have been completely fine. Had general malaise for three weeks solid. And now it's gone.
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| 38 | 2021-02-22 | shortness of breath, head discomfort, headache |
Within 30 minutes, I turned bright red - my face and my forearms. Not a rash or raised rash. It was ...
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Within 30 minutes, I turned bright red - my face and my forearms. Not a rash or raised rash. It was a deep red flushing. I took a dose of oral Benadryl it didn't go away. It felt like a sunburn. I had a headache starting at the back of my head. 1st and second day, I had pain in my joints. Not muscular pain. It came and went the joint pain - behind my left knee was hurting really bad and then it went away. Then my right wrist would start hurting and then it would go away, etc. The second day, the headache was more mild - like a mild pressure in my head. The redness was still there - the red face and red arms. My left arm at the site was cherry red and about the size of two inch circle and somewhat raised. The third day, my headache was worse. It was not like a normal headache but an overall pressure in head. Pink and a bit larger but didn't hurt as bad on arm- the redness continued for six days on my face. The headache lasted 14 days straight - Motrin, ice, heat and extra sleep was tried for treatment. On 15th day it started to let up. On 16th day, it was very mild headache. On the 17th day, it was a full blown headache again. Day 18 it was gone. On the second week, I had mild pain in my stomach and then that went away. On day 3, I had about an hour - twice that day - where I was short of breath and then it went away - it was just that day - about noon and at night. I took Benadryl and when I woke up that didn't happen again. Doctor called on day 12 - when my headaches weren't going away. He took some labs. My labs were normal except thyroid (and I already have a condition for my thyroid). Dr. gave me a medication for headache but I didn't take it - it had a possibility of making me tired and I didn't want to take it.
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| 38 | 2021-02-28 | malaise, chills, shortness of breath |
Breathing difficult; Chills; Body aches; Nauseous with and no appetite; Nauseous with and no appetit...
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Breathing difficult; Chills; Body aches; Nauseous with and no appetite; Nauseous with and no appetite; Not feeling too well; One minute she was cold, and then one minute she was hot; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL330Z; Expiration date was not reported) on 26Jan2021 (08:45) at a single dose on the left deltoid (left shoulder area), with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK8176; Expiration date was not reported) on 05Jan2021 (when the patient was 38 years old) for COVID-19 immunization. On 26Jan2021, after the second dose of vaccination, the patient was not feeling too well; had difficulty breathing; had chills; body aches; and was nauseous with no appetite. Along with the chills, the patient further stated that one minute she was cold, and then one minute she was hot on 26Jan2021. The patient did not receive any treatment for the reported events. The outcome of the events was not recovered for 'chills' and 'nauseous with and no appetite'; and was unknown for 'breathing difficult', 'body aches', 'not feeling too well' and 'one minute she was cold, and then one minute she was hot'.
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| 38 | 2021-03-02 | malaise, discomfort |
My right eye,lips and face had discomfort; My right eye,lips and face had discomfort; My right eye,l...
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My right eye,lips and face had discomfort; My right eye,lips and face had discomfort; My right eye,lips and face had discomfort; I felt malaise for the rest of that day; right sided discomfort; This is a spontaneous report from a contactable nurse (patient). This 38-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231) via an unspecified route of administration on 21Jan2021 at 14:00 (at the age of 38-years-old) as a single dose in the right arm for COVID-19 immunization. The patient did not have any medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccine, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient reported taking unspecified concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 21Jan2021 at 14:30 the patient experienced right sided discomfort. Her right eye, lips, and face had discomfort; not pain but a strange feeling. The patient also felt malaise for the rest of that day (21Jan2021) and the following day. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcome of right sided discomfort, right eye, lips, and face discomfort, and malaise was recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 38 | 2021-03-02 | headache |
Severe body aches and headaches 12 hours after administration of 2nd dose.; Severe body aches and he...
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Severe body aches and headaches 12 hours after administration of 2nd dose.; Severe body aches and headaches 12 hours after administration of 2nd dose.; First dose's administration date 13Jan2021, second dose's administration date: 30Jan2021; First dose's administration date 13Jan2021, second dose's administration date: 30Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262, expiry date: not reported), via an unspecified route of administration at left arm on 30Jan2021 at SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included polycystic ovary syndrome (PCOS), gilbert's syndrome, bipolar disorder, and allergies to sulfa. The patient received unspecified concomitant medication received within 2 weeks of vaccination. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283), at left arm on 13Jan2021 at 06:30 PM for COVID-19 Immunisation. On 31Jan2021 at 04:30 AM, the patient experienced severe body aches and headaches 12 hours after administration of 2nd dose. The reporter considered the events non-serious. There was no treatment received for the events. It was also reported that since the vaccination, the patient has not been tested for COVID-19. The outcome of the events severe body aches and headaches was unknown. No follow-up attempts are possible. No further information is expected.
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| 38 | 2021-03-05 | fever |
# AKI with non-nephrotic range proteinuia and microscopic hematuria # Neutrophilia # Fevers # Nor...
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# AKI with non-nephrotic range proteinuia and microscopic hematuria # Neutrophilia # Fevers # Normocytic anemia # Thrombocytosis # Coagulopathy # RUE Superficial venous thrombosis # Subconjunctival hemorrhage # Flame hemorrhage R fundus # Mild iridocyclitis # CRP elevation # Procalcitonin elevation # D Dimer elevation # Anasarca # Elevated BNP # Hypoalbuminemia # Small pericardial effusion # Elevated alk phos, bilirubin (direct predominant), and AST # Elevated lipase # Hypocomplementemia with low CH50 # Elevated IL2 Receptor (8540) # Aseptic meningitis w CSF with lymphohistiocytic predominant pleocytosis (25 nuc cells with 49% lymphs, 35% histiocytes, 16% pmn, glucose 41, protein 155 with neg meningoencephalitis panel)
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| 38 | 2021-03-09 | headache, dizziness |
symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; s...
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symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; This is a spontaneous report from a contactable Other HCP. A 38-year-old non-pregnant female received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 (Lot number: EL3302) via intramuscular route of administration at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included environmental allergies, Type 2 diabetes mellitus, Mixed hyperlipidemia, Attention deficit hyperactivity disorder, Obesity and Anxiety from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium at 20mg, Desogestrel/Ethinylestradiol (Azurette) at (23) 0.15mg-0.02mg (21)/0.07mg (S), clotrimazole and betamethasone at 1%-5%, cyclobenzaprine at 10mg, escitalopram oxalate (lexapro) at 20mg, metformin at 500mg, esomeprazole magnesium (nexium) at 20mg, montelukast sodium (singulair) at 10mg, amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (Adderall) at 20 mg, cetirizine hydrochloride (zyrtec) at 10 mg, fluticasone proplonate at 50mcg. It was unknown if the patient had illnesses at the time of vaccination and up to one month prior. Patient was seen in office on 27Jan2021 and reported symptoms of Headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors causing change in handwriting for the past 1.5 to 2 weeks after receiving vaccination. Upon review of Neurological symptom, patient was positive for loss of balance and coordination 4/5 strength. In all extremities, and 4/5 grip strength, CT of Head with and W/O contrast was ordered. CBC, CMP, free T4, HgbA1c, lipid, 'TSH, Urinalysis, Vitamin B12, Folate and CK laboratory ordered. CT Head with and w/o Contrast on 27Jan2021 showed no acute intracranial process Identified. No evidence of enhancing lesion. Patient had not completed laboratory at this time. It was unknown if the patient had doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
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| 38 | 2021-03-18 | chills, headache, fever |
Episode of Syncope which caused a fall; Episode of Syncope which caused a fall; Headache; Chills; Fe...
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Episode of Syncope which caused a fall; Episode of Syncope which caused a fall; Headache; Chills; Fever; Body Aches; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration, administered in the left arm on 26Feb2021 at a single dose (at the age of 38-years-old) for Covid-19 immunisation in a workplace clinic. Medical history included allergies, migraines, low vitamin D and penicillin. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took Bactrum and doxycycline and experienced allergies. The patient was not pregnant at time of vaccination. The patient took the first dose of BNT162B2 on 05Feb2021 10:30 in the left arm at the age of 38-years-old for Covid-19 immunisation. No other vaccine was received in four weeks. The patient did not have COVID prior to vaccination. On 27Feb2021 at 02:30 AM, the patient experienced headache, chills, fever, body aches and an episode of syncope which caused a fall. The events resulted in emergency room/department or urgent care. The patient had a CatScan, EKG, IV medications, blood and urine test. The patient was not tested for COVID post vaccination. The patient recovered from the events on an unspecified date.
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| 38 | 2021-03-22 | dehydration, weakness, fever |
103 .5 fever; dehydration; muscle aches; vomiting; weakness; This is a spontaneous report from a con...
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103 .5 fever; dehydration; muscle aches; vomiting; weakness; This is a spontaneous report from a contactable Nurse. A 38-year-old female patient (no pregnant) received 2nd dose of BNT162B2 (lot number=ENS318) Intramuscular on 03Mar2021 10:00 AM on Left arm for COVID-19 immunisation. Medical history was Fibromyalgia, allergic to insect stings and fleas. No other vaccine in four weeks. Other medications in two weeks included venlafaxine hydrochloride (EFFEXOR), gabapentin, cefixime (FLEXERIL), and hydrocodone bitartrate/paracetamol (NORCO). Historical Vaccine was 1st does of BNT162B2 (lot number=ENS 318) Intramuscular on 10Feb2021 11:00 AM on Left arm for COVID-19 immunisation. Patient experienced 103 .5 fever, dehydration, muscle aches, vomiting and weakness from 03Mar2021 06:00 PM with outcome was recovering. Events resulted in Emergency room/department or urgent care, Hospitalization (1 day). Treatment included IV fluids, Tylenol, Zofran. Drew labs which were normal. No covid prior vaccination. Covid test post vaccination: Nasal Swab Negative on 04Mar2021, PCR Result Pending. No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Sender's Comments: Based on the close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported fever, dehydration, muscle aches, vomiting and weakness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 38 | 2021-03-29 | malaise, fever, fatigue, headache |
Arm soreness; headache; body aches; low fever; general fatigue; feeling of illness; This is a sponta...
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Arm soreness; headache; body aches; low fever; general fatigue; feeling of illness; This is a spontaneous report from a contactable healthcare professional (patient). This 38-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) on 23Feb2021 at 14:00 (at the age of 38-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included psoriatic arthritis and hidradenitis suppurativa. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included spironolactone (ALDACTONE) and women's multivitamin from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 on 27Jan2021 at 14:30 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 23Feb2021 at 23:30 the patient experienced "same as generally expected," arm soreness, headache, body aches, low fever, general fatigue, and feeling of illness. The event were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of arm soreness, headache, body aches, low fever, general fatigue, and feeling of illness were recovering. It was also reported that since the vaccine the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 39 | 2020-12-31 | fever, discomfort, fatigue, cough, headache |
About 45 mins to an hour of receiving the vaccination , i felt a terrible pounding headache, I took...
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About 45 mins to an hour of receiving the vaccination , i felt a terrible pounding headache, I took Tylenol ES 500mg after felt relief but decided to sleep early. When I woke up this morning my injection site arm felt so painful and heavy and i had fevers between 103-101.5 though I took some tylenol 500mg every 6 hours. Tachycardic between 140-120bpm, i still have terrible headache, muscle & joint pains, extreme fatigue. Some dry cough but no shortness of breath.
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| 39 | 2020-12-31 | shortness of breath | HIVES, SOB, THROAT CLOSING UP, WHEEZING |
| 39 | 2020-12-31 | chills, fever, headache, weakness | Severe Headache for 3 days, chills weakness and fevrerish |
| 39 | 2020-12-31 | headache, fever, malaise, fatigue, chills | Tiredness, fever (101.2), chills, muscle pains, headach, feeling unwell |
| 39 | 2021-01-01 | sweating, weakness, cold sweat, fatigue |
Covid Pfizer vaccine dose one on 12/21/20 - at 18 minutes post vaccination, globus sensation, diapho...
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Covid Pfizer vaccine dose one on 12/21/20 - at 18 minutes post vaccination, globus sensation, diaphoresis, neuropathic crawling all over scalp, loss of consciousness, heart rate 35 bradycardia event. Responders said I was out for a minute or so then regained consciousness. Pupil dilation during event per responders. ICU MD responder states no radial pulse but had carotid pulse which was weak at initial loss of consciousness. Given fluids. Blood pressure normal during fluids. Improved heart rate without tachycardia. Had recurrence of clammy hands, globus sensation with frequent swallowing/throat clearing about 30 minutes after initial event while still receiving fluids. No airway compromise or stridor. Received PO Benadryl 25 mg. Transferred to ER for monitoring for an additional 90 minutes with complete resolution of globus sensation about 30 minutes after Benadryl. Fatigue and weak post event.
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| 39 | 2021-01-01 | dizziness | Within 45 min, patient had nausea, dizziness, and was given ondansetron and fluids with improvement |
| 39 | 2021-01-01 | shortness of breath |
shortness of breath, difficulty breathing, chest tightness. She administered epinephrine and recover...
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shortness of breath, difficulty breathing, chest tightness. She administered epinephrine and recovered quickly
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| 39 | 2021-01-02 | sweating, headache, respiratory tract congestion, fatigue, throat irritation |
23rd: hot flash/sweating within 15 minutes of receiving vaccine, Sore am, itchy throat, horse voice...
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23rd: hot flash/sweating within 15 minutes of receiving vaccine, Sore am, itchy throat, horse voice; 24th: sore arm, headache, fatigue, congestion; 25th: headache, nausea, fatigue, congestion. 26th through today - daily Headache w/nausea (OTC's not helping headaches).
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| 39 | 2021-01-03 | dehydration, fever, headache, fatigue, chills, dizziness |
12/29/20 ~1115 Received Pfizer COVID-19 vaccine. Only issue within the 15minute wait time is tendern...
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12/29/20 ~1115 Received Pfizer COVID-19 vaccine. Only issue within the 15minute wait time is tenderness in injection site. No adverse effects until 2 pm (dizziness, headache, fatigue, nausea, chills). Got home by 5pm. Worsened symptoms. Temperature hit 40C. Myalgias and joint pain started. Took Tylenol 1gm. Recurrent fever and chills. Symptoms did not get better. 12/30/20 started having pressure and stabbing chest pain. Went to ED for dehydration and nausea. Negative chest xray and troponin. COVID PCR also negative. As of 1/4/2021, writer is still experiencing same symptoms to a lesser extent.
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| 39 | 2021-01-03 | fatigue, headache, night sweats, malaise |
2 hrs post injection sudden onset of severe dry mouth that lingered but gradually resolved. Still dr...
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2 hrs post injection sudden onset of severe dry mouth that lingered but gradually resolved. Still dry next morning and a couple hrs later it switched to increased salivation. The evening after injection I had a headache and just felt general malaise and fatigue, "run down". Difficulty sleeping that night due to body aches. HEadache, neck and lower back pain. Skin sensitivity when touched, bed sheets kinda hurt my skin. The bodyaches and malaise persisted through out day 2. Tylenol seemed to help. I slept better that night but woke up with night sweats, completely drenched. Arm pain at injection site on day 2 that resolved by mid day. Now 1 week later I have extreme fatigue yesterday and today. I do have hypersomnia but not even my adderall is helping. Not sure if this is related or not.
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| 39 | 2021-01-03 | weakness, fatigue |
Around 24 hours post COVID vaccination into her left delt, she woke up with severe left shoulder an...
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Around 24 hours post COVID vaccination into her left delt, she woke up with severe left shoulder and neck muscle pain. She got in touch with her provider and was treated with valium and Celebrex. She reported about 2 cm swelling and fatigue. Thirty hours post vaccination, she had pain and swelling and could barely move. Dr. needed to take valium and Celebrex though for those 48 hours, and would have gone to the ER if they had not helped (the pain was that debilitating)
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| 39 | 2021-01-03 | chills, sweating, headache, shortness of breath, fever | Headache sweats body chills fever trouble breathing |
| 39 | 2021-01-03 | shortness of breath, sweating, dizziness |
I developed immediate flushing, sweating, rapid heartbeat (was around 110bpm, is normally around 75b...
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I developed immediate flushing, sweating, rapid heartbeat (was around 110bpm, is normally around 75bpm), and lightheadedness. I sat down and had a few sips of water. Within a few minutes, I felt like I was having a difficult time getting a good breath in. I raised my hands over my head and took slow deep breaths to try and keep my breathing under control. I stayed at the hospital for about 45 minutes, over which time I had a few bites to eat and some water. The flushing and sweating resolved within that time. The lightheadedness and "feeling of doom" lasted about 3 hours. I had no anxiety going into this vaccine, nor have I had a reaction like this before.
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| 39 | 2021-01-03 | sweating, malaise, fever, fatigue, headache, dizziness |
I received the COVID vaccine on Monday Dec. 21, 2020 at 14:30. By 17:00 I was not feeling well. I ...
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I received the COVID vaccine on Monday Dec. 21, 2020 at 14:30. By 17:00 I was not feeling well. I was tired, had a headache, muscle aches, nausea and a fever of 101 F. The headache, low grade fever and significant malaise continued through Tues Dec 22 and Wed Dec 23. On Thursday morning Dec 24 at 2:30 AM, I woke from sleep with the urge to use the bathroom. I suddenly felt light-headed and dizzy and had a diaphoresis that soaked my hair and PJs. Fortunately my husband who is a nurse anesthetist helped me through the episode safely and was able to get me back to bed. I am not sure if that event was related to the vaccine or if I happened to be a little dehydrated and had a vaso-vagal event. I did not take any medications because I was allowing my body to have a natural response to the vaccine.
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| 39 | 2021-01-03 | fever, chills |
Nausea, chills, arthralgia/myalgia, low-grade fever: all symptoms began 16 hours after vaccine and s...
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Nausea, chills, arthralgia/myalgia, low-grade fever: all symptoms began 16 hours after vaccine and subsided within 24 hours of vaccine.
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| 39 | 2021-01-03 | headache, shortness of breath, fatigue |
Pfizer-BioNTech COVID-19 Vaccine EUA 12-31-2020 Nausea & Headache, 1-1-2021 Headache 1-2-2021 Heada...
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Pfizer-BioNTech COVID-19 Vaccine EUA 12-31-2020 Nausea & Headache, 1-1-2021 Headache 1-2-2021 Headache & shortness of breath, 1-3-2021 Headache, shortness of breath, fatigue,& cold sore on top lip, 1-4-2021 Headache, shortness of breath, cold sore, fatigue, and right shoulder blade and neck hurts.
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| 39 | 2021-01-03 | skin warm |
Severe hives all over body- trunk of body fully covered in raised, red, blotchy, "firey" patches of ...
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Severe hives all over body- trunk of body fully covered in raised, red, blotchy, "firey" patches of hives; also, under armpits, over the shoulders, panty lines, behind knees, on and under breasts, back, onto neck and face (chin, lip area, eye brow area)
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| 39 | 2021-01-03 | fever |
Tingling in lower legs- neuropathy like; Fever 102.9; Tingling in lower legs- neuropathy like; Sever...
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Tingling in lower legs- neuropathy like; Fever 102.9; Tingling in lower legs- neuropathy like; Severe cramping in hands and feet; Severe bone pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the first dose of bnt162b2 (COVID-19 vaccine) lot no: EL0140, via an unspecified route of administration in left arm on 18Dec2020 15:15 at a single dose for COVID-19 immunization. Medical history included acid reflux and known allergies to PCN, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of report. Concomitant medication included omeprazole (PROTONIX), ibuprofen (MOTRIN). No other vaccines were administered in four weeks. On 19Dec2020 at 14:30, the patient experienced fever 102.9 "normal for vaccines i know", tingling in lower legs neuropathy like, severe cramping in hands and feet, and severe bone pain. The patient recovered from the events in Dec2020. The patient did not receive treatment for the events. The events were reported as non-serious. The patient didn't have COVID prior to vaccination and was not tested post vaccination.; Sender's Comments: A possible causal association between administration of bnt162b2 and the onset of neuropathy like cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 39 | 2021-01-03 | cough, throat pain, runny nose |
Vaccinated at mass vaccination event for nursing home staff and residents on 12/18/2020. Developed c...
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Vaccinated at mass vaccination event for nursing home staff and residents on 12/18/2020. Developed cough, runny nose, sore throat, loss of taste and smell and tested positive for COVID-19 on 12/24/2020. Had exposure to COVID+ mother whom she takes care of.
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| 39 | 2021-01-04 | nerve pain |
48 hours after covid vaccine, acute onset neuralgia - nerve pain involving entire body (had shingles...
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48 hours after covid vaccine, acute onset neuralgia - nerve pain involving entire body (had shingles 1 year ago - same type pain but this time head to toe, comes and goes but consistent).
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| 39 | 2021-01-04 | chills, malaise, headache, dizziness |
Administration of vaccine was given about 3 inches too low, not sure if it went into muscle or subcu...
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Administration of vaccine was given about 3 inches too low, not sure if it went into muscle or subcutaneous but I did end up with an injection site reaction 2 days later to include a 2x3 inch red, itchy, raised, hot to the touch welt. Also had extreme dizziness, nausea, headache 2 days after injection. Dizziness, nausea, headache subsided after 24hrs however injection site reaction will go away and come back randomly. Seems to coincide with getting sick? Was fine up until 12/29 when I did end up getting sick to include headache, body aches, chills. I went to go get covid tested which was negative. I ultimately had a sinus/ear infection. However injection site reaction had gone away UNTIL I got sick on 12/29 then it showed up again and still have it as of today.
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| 39 | 2021-01-04 | headache, dizziness | Dizziness, headache |
| 39 | 2021-01-04 | fatigue |
Employee was feeling fatigued on Mon, 1/4. By Tuesday afternoon while at work, she was experiencing ...
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Employee was feeling fatigued on Mon, 1/4. By Tuesday afternoon while at work, she was experiencing body aches and "felt my heart racing." She was sent to the ER by her supervisor and her SBP was 180s and HR was 120s. Employee does not have a hx of HTN or heart conditions.
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| 39 | 2021-01-04 | chills, fever, fatigue | Fever of 100.2, chills, fatigue, sore arm |
| 39 | 2021-01-04 | chills, fever, headache | Fever, chills, nausea, headache, body aches |
| 39 | 2021-01-04 | fatigue, malaise, headache |
Headache; fatigue; general malaise; This is a spontaneous report from a contactable nurse (patient)....
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Headache; fatigue; general malaise; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number EJ1685, via an unspecified route of administration on Left arm from 22Dec2020 09:00 to 22Dec2020 09:00 as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included ademetionine (SAME). On 24Dec2020 09:00, the patient experienced headache, fatigue, general malaise at about 48 hours after receiving vaccine. Lasted about 1 day. The outcome of the events was recovered on 25Dec2020.
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| 39 | 2021-01-04 | fever, fatigue, malaise, runny nose, headache |
I had arm soreness from the time of injection to the next few days, Saturday morning I had moderate ...
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I had arm soreness from the time of injection to the next few days, Saturday morning I had moderate tiredness and body aches and headaches that were really bad until the 23rd that was sporadic. I felt feverish malaise really bad headache and body aches. I took Tylenol and Advil around the clock. on the 20th I also had very mild runny nose for 2 days. I went to get a covid test on the 23rd and it was negative. Symptoms resolved by the 25th I had no symptoms
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| 39 | 2021-01-04 | sweating |
PT was verbalizing prior hesitancy to vaccine once received @ 10:58 - 3 minuets post injection PT C/...
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PT was verbalizing prior hesitancy to vaccine once received @ 10:58 - 3 minuets post injection PT C/O neck/ throat feeling tight, sis increased to C/O feeling like heart was racing, feeling diaphoretic and shaky. EMS called to car for assessment BP- 156/106 pulse - 110 follow pulse - 76 BP- 132/87. PT up and standing to help case symptoms PT had also C/O L side pain after dose administered, 11:30 patient states she starts to feel ok, then she no longer feels "normal" C/O heaviness in head/ neck.
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| 39 | 2021-01-04 | chills |
Patient having extreme chills starting at 6am. She took anti-inflammatory and came to work. Temp 97....
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Patient having extreme chills starting at 6am. She took anti-inflammatory and came to work. Temp 97.8
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| 39 | 2021-01-04 | cold sweat, chills, fatigue |
Pfizer-BioNTech COVID-19 Vaccine EUA I recieved the vaccine at 0800 on 1/2/21. By 1430 I started fe...
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Pfizer-BioNTech COVID-19 Vaccine EUA I recieved the vaccine at 0800 on 1/2/21. By 1430 I started feeling tired with some chills. By 1700, I was having nausea and vomiting. I woke the next day (1/3) around 0700 still having nausea, but also my hands and feet were very cold and my arms and legs were cold and clammy. This continued throughout the day. It is now 1/5 and I'm still having some nausea and my extremities are still cold and will sometimes tingle.
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| 39 | 2021-01-04 | headache, chills, fever |
burning of eyes; hot flashes followed by rigors; severe muscle pain; For hrs post injection I had ho...
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burning of eyes; hot flashes followed by rigors; severe muscle pain; For hrs post injection I had hot flashes; skin pain; joint pains; numbness of the whole arm; site pain; Headaches; low grade fever; This is a spontaneous report from a contactable nurse (patient). A 39-years-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EJ1685, Expiration Date: 31Mar2021), via an unspecified route of administration in left arm on 28Dec2020 09:00 at single dose for COVID-19 immunization. Medical history included obesity, asthma, hypothyroidism, vitamin D deficiency, multiple tendonitis, allergies to horses, cats, and dogs and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included mometasone furoate (ASMANEX), colecalciferol (VITAMIN D), levothyroxine sodium (SYNTHROID) and hydroxychloroquine, all received within 2 weeks of vaccination. The patient stated for hours post injection she had hot flashes but the worst was 12hrs after. She experienced severe muscle pain/ skin pain, joint pains, burning of eyes, Headaches, low grade fever, site pain, numbness of the whole arm, hot flashes followed by rigors. The events started on 28Dec2020 21:00. Treatment received for the events included Tylenol. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolving.
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| 39 | 2021-01-04 | dizziness, chills |
feeling really dizzy; Blood pressure was kind of high; Chills; Feeling little cold; Pulse was like 1...
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feeling really dizzy; Blood pressure was kind of high; Chills; Feeling little cold; Pulse was like 100; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL0140), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 vaccine. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL). The patient was feeling really dizzy, and it started maybe like 5 to 7 minutes after received it, and patient laid in a room and blood pressure was kind of high and patient was feeling chills and little cold and pulse was like 100. Treatment in response to the adverse events included fluids just like water and juices. Patient drank like 2 or 3 juices and a bottle of water and laid down in the bed at the hospital probably for about an hour. Due date for next shot for patient was 12Jan2021. Outcome of events was unknown.
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| 39 | 2021-01-04 | throat pain |
result back w positive covid; positive COVID-19 test with symptoms; This is a spontaneous report fro...
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result back w positive covid; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse reporting for herself. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 19Dec2020 11:00 (at age 39 years old) as a single dose (Dose 1) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient was not administered any other vaccine in the 4 weeks prior to COVID-19 vaccination. Medical history was none. There were no allergies to medication, food, or other products. The patient's concomitant medications were not reported; however the patient had not received any other medications in the last 2 weeks. The patient experienced a sore throat, voice loss on day 4, loss of smell on day 5, went to test, and the result came back with positive COVID. The events resulted in a Doctor's office visit. The patient was tested post vaccination on 22Dec2020 via NAAT-PCR (nasal swab), with a positive result. The patient had not been diagnosed with COVID-19 prior to vaccination. There was no treatment received for the event(s). The clinical outcome of the event positive COVID was unknown The event was reported as non-serious. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The association between the event drug ineffective (COVID-19 infection) with BNT162b2 can not be fully excluded.
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| 39 | 2021-01-05 | sweating, headache, weakness, fatigue, shortness of breath |
10 MINUTES after the injection, I became very hot and flushed, with headache, palpitations, weakness...
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10 MINUTES after the injection, I became very hot and flushed, with headache, palpitations, weakness, and shortness of breath. I sat down, my heart rate was 110 on my I watch. I was breathing heavy and feeling sweaty. The healthcare providers had me lie down on a stretcher and gave me oxygen with my feet elevated. After about 20 minutes, I felt better. Later that day, I came home and slept for 2 hours. The next day, (today) I came home early from work because I feel very tired and having difficulty concentrating. But the other symptoms have gone away.
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| 39 | 2021-01-05 | dizziness, throat irritation | 15 to 30 minutes after vaccination experienced itchy throat and tongue and dizziness |
| 39 | 2021-01-05 | headache |
Approximately 3 days after initial injection, experienced significant brain fog, aphasia, panic, hea...
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Approximately 3 days after initial injection, experienced significant brain fog, aphasia, panic, headache, dropping things.
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| 39 | 2021-01-05 | dizziness | Dizziness, NauseaVomiting, Arm soreness |
| 39 | 2021-01-05 | fever |
Fever of 100 degrees for one week; This is a spontaneous report from contactable healthcare professi...
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Fever of 100 degrees for one week; This is a spontaneous report from contactable healthcare professional, the patient. A 39-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 16Dec2020 at 09:00 (reported as at the age of 39-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Dec2020, the patient experienced fever of 100 degrees Fahrenheit for one week. The patient went to the doctor for the event but was not given any treatment. The patient was tested twice for COVID-19 during the week of the fever in Dec2020 and both time the results were negative. The clinical outcome of fever of 100 degrees Fahrenheit for one week was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 39 | 2021-01-05 | headache | Headache |
| 39 | 2021-01-05 | chills, headache | Myalgias, chills, nausea/vomiting, headache |
| 39 | 2021-01-05 | headache | Patient woke on 1/01/2021 with headache; swelling of left-side of neck; swelling of tongue |
| 39 | 2021-01-05 | fatigue, dizziness, chills, weakness, shortness of breath |
blood pressure went up to 150/101; feeling like fainting; feeling really tired; Weakness; irregular ...
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blood pressure went up to 150/101; feeling like fainting; feeling really tired; Weakness; irregular heart beat; sob; feeling like flushing in the body; chills; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 30Dec2020 07:15 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, depression, cardiac murmur and pvc. The patient hadno known drug allergies and had not tested for COVID-19 prior and after vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID), ergocalciferol (VITAMIN D), tocopherol (VITAMIN E) and sertraline hydrochloride (ZOLOFT). The patient experienced weakness, irregular heart beat, feeling like fainting, sob, blood pressure went up to 150/101, feeling like flushing in the body, chills, feeling really tired, all on 30Dec2020 07:15. The patient received treatment. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "blood pressure went up to 150/101" with BNT162b2 can not fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 39 | 2021-01-05 | throat irritation, throat swelling | experienced throat "swelling" and itchy throat 5 minutes after vaccine |
| 39 | 2021-01-05 | headache, fever |
extreme soreness at injection site; GI upset; sleeplessness; mild fever; pain radiating down left ar...
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extreme soreness at injection site; GI upset; sleeplessness; mild fever; pain radiating down left arm and up to behind left ear; pain radiating down left arm and up to behind left ear; neck tightness; mild headache; This is a spontaneous report from a non-contactable Nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at left arm on 29Dec2020 10:30 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroid, PCOS (polycystic ovarian syndrome), sulfa allergies. Concomitant medications included unknown medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 29Dec2020 13:00, the patient experienced extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild headache. The patient has not been tested for Covid-19 since the vaccination. The patient did not receive treatment for the events. The outcome of the events extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild head ache was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
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| 39 | 2021-01-05 | shortness of breath |
heart rate spiked; difficult to catch breath; This is a spontaneous report from a contactable health...
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heart rate spiked; difficult to catch breath; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration in the right arm, on 18Dec2020 (at the age of 39-years-old) at a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis, depression, acid reflux, and COVID-19 (prior to vaccination). The patient has no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications, within two weeks prior to vaccination, included sertraline (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), liothyronine sodium (T3), and levothyroxine sodium (T4). The patient experienced heart rate spiked and difficult to catch breath on 20Dec2020. The events were reported as non-serious. The clinical course was reported as follows: In Dec2020, the heart rate spiked to 194 when running outside and it was difficult to catch breath, so the patient ran/walked the 3 mile route. The heart rate spiked to 183 during a strength training workout and to 148 during a low impact weight training, which is unusual for the patient (as reported). The patient did not receive any treatment for the events. The clinical outcome of heart rate spiked and difficult to catch breath was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 39 | 2021-01-05 | fatigue, body temperature increased, headache | temp 99.5, fatigue, body aches, headache |
| 39 | 2021-01-06 | headache, weakness |
(1/5/21 at 3:45pm) About 20 minutes after the vaccination I felt weak and with a headache, for the ...
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(1/5/21 at 3:45pm) About 20 minutes after the vaccination I felt weak and with a headache, for the rest of the day. (1/6/21) It was my day off, I was still weak and headache I took Tylenol for the pain. (1/7/21) About 3:00 am I had a lot of headache I got up and took 2 Tylenols,the pain continued but more bearable I went to work at 6am always with a headache and feeling weak. From work they sent me home so that I could take the Covid Test, and also do this report.
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| 39 | 2021-01-06 | migraine |
1st night severe rash over torso, arms, and face. 2 days later vomiting and diarrhea. The whole week...
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1st night severe rash over torso, arms, and face. 2 days later vomiting and diarrhea. The whole week after vaccine horrible migraines.
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| 39 | 2021-01-06 | dizziness |
About 1 hour after receiving the vaccine she began to feel dizzy, felt like she was going to pass ou...
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About 1 hour after receiving the vaccine she began to feel dizzy, felt like she was going to pass out, racing heart and pupils became constricted.
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| 39 | 2021-01-06 | skin warm, dizziness, throat swelling |
Approx 2 minutes after injection I felt warm, flush, tachycardic, dizzy, my hands were shaking and m...
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Approx 2 minutes after injection I felt warm, flush, tachycardic, dizzy, my hands were shaking and my throat felt numb and a little swollen. I was still able to swallow and symptoms did improve after 15 minutes.
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| 39 | 2021-01-06 | dizziness, chills, headache |
At approximately 3am (11 hrs after vaccine), had chills, body aches, severe headache, dizziness. Ch...
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At approximately 3am (11 hrs after vaccine), had chills, body aches, severe headache, dizziness. Chills lasted about 4-5 hours, body aches x 24 hrs, and headache 24 hrs.
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| 39 | 2021-01-06 | nasal congestion, headache | Back pain, body pain, headache, stuffy nouse. Went to do covid test and came positive |
| 39 | 2021-01-06 | fatigue, chills | Body aches, chills, fatigue |
| 39 | 2021-01-06 | weakness, dizziness |
Dizziness and weakness - lasting approximately 45 minutes. Slight dizziness continues now (approx 11...
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Dizziness and weakness - lasting approximately 45 minutes. Slight dizziness continues now (approx 11am) but is subsiding, but continues. Pfizer's information sheet said this may be a sign of an allergic reaction. No medical follow up seems necessary right now, but important to report.
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| 39 | 2021-01-06 | dizziness, fatigue, headache | Dizziness, severe headache, abdominal pain, diarrhea, nausea, fatigue, and muscle pain |
| 39 | 2021-01-06 | chills, fever | Fever High heart rate Chills |
| 39 | 2021-01-06 | headache | Headache & NauseaVomiting |
| 39 | 2021-01-06 | fever, fatigue |
I am not sure if this was a result of the vaccine or not and am trying to be helpful! I woke up 1/4/...
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I am not sure if this was a result of the vaccine or not and am trying to be helpful! I woke up 1/4/2020, feeling nauseous. I vomited about 6 times that day and had diarrhea. Next morning, my face was flushed. I had a low grade fever of 99.5, and checked my BP. On my home machine, my pulse was 135. I decided to go to the hospital. My Apple Watch measured my heart rate to be 150 at one time. At the ER, I was diagnosed with sinus tachycardia and dehydration. I was placed on oxygen as my levels were between 90-93, and I was given IV fluids. I have felt fatigued since then, some nausea, and mild diarrhea still.
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| 39 | 2021-01-06 | headache, fatigue | Joint and Muscle pain, Fatigue, headache and soreness at injection site. |
| 39 | 2021-01-06 | malaise, fever |
Moderate to severe itching at all prior scar sites, some decades old. Severe itching/discomfort sur...
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Moderate to severe itching at all prior scar sites, some decades old. Severe itching/discomfort surrounding Nexplanon implant. Previously broken/fractured bones, and site of 20 year old rotator cuff tear, all throb with dull pain as if they are new injuries. General feeling of malaise, lack of appetite, and mental fogginess. All symptoms continue to persist still 48 hours after vaccination. Also experienced fever of approx. 102 degrees for roughly 24 hours.
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| 39 | 2021-01-06 | fatigue | Nausea and vomiting within 30-45 minutes Fatigue and sore muscles the following day |
| 39 | 2021-01-06 | dizziness |
Sxs 10 minutes post vax with nausea, lightheadedness, flushed. Taken to ED from vax site. Given IVF...
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Sxs 10 minutes post vax with nausea, lightheadedness, flushed. Taken to ED from vax site. Given IVF, Zofran inj.
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| 39 | 2021-01-06 | headache |
When I got my first shot of the vaccine , I had some of the symptoms mentioned including a headache ...
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When I got my first shot of the vaccine , I had some of the symptoms mentioned including a headache but after 24 hours , everything went away, however a few days after after , my headache Came back and has not gone away ever since , yesterday , I went to get my second vaccine but thankfully my headaches haven?t gotten worst.
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| 39 | 2021-01-06 | thirst, body temperature increased, chills, fatigue, headache, weakness |
Woke up at 3am with the chills took my temp was 99.8. Took my morning medicines and then some ibupr...
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Woke up at 3am with the chills took my temp was 99.8. Took my morning medicines and then some ibuprofen, was having body aches and severe chills. Went back to bed and took my temp an hour later was 101.0. Had body aches, chills, thirst, weakness, headache for the rest of the day. Temperature went from 99.0 to the highest of 102.0. Got ahold of covid 19 hotline at work, they said it was a reaction to the shot and should be gone within 72hrs. If not then I would need to get covid tested. Got ahold of my pcp and they ordered a covid test but I told them what the hotline had said and that I would wait to get one done. It has been 24 hour since and now I no longer have a fever and am feeling better just tired.
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| 39 | 2021-01-06 | fever | fever of 101.0 |
| 39 | 2021-01-06 | fever | fever, vomiting and rash |
| 39 | 2021-01-06 | migraine, body temperature increased |
site soreness (started within 3 hours of injection and is still sore 2 days later) , sleep disturban...
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site soreness (started within 3 hours of injection and is still sore 2 days later) , sleep disturbance night of injection, elevated temp of 100deg (started at 0200 on the 6th and lasted for 24 hours), whole body aches esp neck and back pain (Started when temp started and has lasted after temp has stopped for a total of 31 hours). Migraine with sensitivity to light (started at 0400 on the 6th and lasted for 5 hours). Nausea and heartburn (started on the 6th at 1845 lasting 5 hours despite taking famotidine)
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| 39 | 2021-01-06 | pneumonia, fever, throat pain |
woke up with fever and sore throat on 22nd; went to job and got tested and tested positive; on the 2...
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woke up with fever and sore throat on 22nd; went to job and got tested and tested positive; on the 23rd developed right upper lobe pneumonia; on 27th was hospitalized with three lobe pneumonia; On 22nd received got zpack - azithromycin and sudafed; received at hospital doxicycleln IV ; ivermectin and went home with them, as well. Hospital
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| 39 | 2021-01-07 | throat irritation, dizziness |
1000- Employee receives vaccination 1015- Pt reports dizziness to staff 1015- Pt assisted to priva...
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1000- Employee receives vaccination 1015- Pt reports dizziness to staff 1015- Pt assisted to private area for evaluation/assessment (Vitals signs, ABCs) - Denies troubles breathing or swallowing, Denies throat swelling or closure. drinking PO liquids and eats cracker 10:21- reports sensation in throat, continues to deny troubles breathing or swallowing 10:28- 25mg liquid PO diphenhydramine administered PO as 25mg/10mL PO diphenhydramine 10:31- No improvement/worsening in symptoms- emergency response team called to evaluate employee Pt is transported to Urgent Care via wheelchair per Pt request
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| 39 | 2021-01-07 | throat irritation, dizziness |
1000- Pt received vaccine (2nd dose) 1015- Pt reported dizziness, denies troubles breathing or swal...
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1000- Pt received vaccine (2nd dose) 1015- Pt reported dizziness, denies troubles breathing or swallowing Pt assisted to private area- Vital signs checked and assessed for airway, breathing, circulation concerns- denies 1021- Pt reports unusual sensation in throat, continues to deny difficulties breathing or swallowing 10:28- 25mg diphenhydramine administered PO as 25mg/10mL PO Liquid diphenhydramine (Pt declines additional 25mg dosing) Denies changes in symptoms- emergency response team is called and arrives to assess Pt Pt is transported to Urgent Care per Pt request
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| 39 | 2021-01-07 | headache, influenza like illness, fever |
5 minutes after receiving shot I felt a strong headache come on. Tylenol did not alleviate the pain....
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5 minutes after receiving shot I felt a strong headache come on. Tylenol did not alleviate the pain. Later in the day I began to feel flu like symptoms with fever reaching 100.3. Same symptoms Day 2. Now, day 3 I still feel flu like symptoms.
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| 39 | 2021-01-07 | fatigue, chills, fever |
At the 10-hour mark after receiving my second dose, I developed a blotchy rash on my chest and neck ...
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At the 10-hour mark after receiving my second dose, I developed a blotchy rash on my chest and neck (no discomfort or itching). At the 12-hour mark I developed severe chills and body aches and exhaustion which came on very quickly. At (approx.) the 13-hour mark my temperature was 103.3 but it never got any higher than that. For the next 24 hours my temperature hovered around 101-102.
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| 39 | 2021-01-07 | fever, chills, headache |
Fever chills headache nauseous joint pain started 12 hrs after shot and lasted 24 hrs felt tired and...
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Fever chills headache nauseous joint pain started 12 hrs after shot and lasted 24 hrs felt tired and weak on day 2
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| 39 | 2021-01-07 | fever, chills |
Fever/chills, left arm rash, itchy legs, myalgias. Tylenol/benadryl with good effect. No symptoms ...
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Fever/chills, left arm rash, itchy legs, myalgias. Tylenol/benadryl with good effect. No symptoms today.
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| 39 | 2021-01-07 | dizziness |
Had itchy hives on face and neck, some lip swelling, dizziness; Denied SOB or throat tightness. Pfi...
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Had itchy hives on face and neck, some lip swelling, dizziness; Denied SOB or throat tightness. Pfizer vaccine was given at 11:45 AM and reaction onset at 11:55. VS at 12:10: BP 132/67; HR: 100; O2 96%; Epi given at 12:22; Was taken to ED for observation. Patient has PMHx of RA and Asthma; Meds include Methotrexate, Advair, Omeprazole, Vit D; Allergies to PCN and Percocet; Had anaphylactic reaction to sucralose for fit test.
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| 39 | 2021-01-07 | headache | Headache upset stomach, metallic taste, loose stool Narrative: |
| 39 | 2021-01-07 | fatigue, fever, headache |
Headache, Myalgia, Arthralgia, Fever, Fatigue Narrative: Significant impact on life, as symptoms res...
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Headache, Myalgia, Arthralgia, Fever, Fatigue Narrative: Significant impact on life, as symptoms result in time out of work
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| 39 | 2021-01-07 | malaise, headache |
Headache, Myalgia, Arthralgia, malaise Narrative: States she compares the side effects similar to th...
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Headache, Myalgia, Arthralgia, malaise Narrative: States she compares the side effects similar to those she experiences after having a Flu vaccine.
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| 39 | 2021-01-07 | fever, chills | Low grade fever of 100.8, myalgias and chills |
| 39 | 2021-01-07 | headache | POUNDING HEADACHE, COULDNT SLEEP, PAIN UNDER ARM PIT, NECK PAIN, SWELING UNDER ARM PIT |
| 39 | 2021-01-07 | fatigue, cough, shortness of breath, headache |
Pt received 1st dose Pfizer COVID vaccine 12/18/20. On 12/21/20 pt presented to Urgent Care with hea...
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Pt received 1st dose Pfizer COVID vaccine 12/18/20. On 12/21/20 pt presented to Urgent Care with headache, hypertensive, nausea/vomiting, shortness of breath, myalgia, fatigue, cough. COVID, Flu A/B, and RSV PCR all negative, CXR negative. Per provider note, potential side effects 2/2 COVID vaccine administration. Pt received compazine, toradol, zofran. Pt did not receive epi, no ED visit.
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| 39 | 2021-01-07 | fever, fatigue | Rash following first dose Second dose: rash, fatigue, body aches, fever |
| 39 | 2021-01-07 | shortness of breath | She has shortness of breath the next day |
| 39 | 2021-01-07 | throat irritation | Tickle in throat / throat itching, Can't get a full swallow, anxious, jittery |
| 39 | 2021-01-07 | dizziness, cold sweat |
Vagal presyncope. Tachycardia. Cold sweat, lightheadedness about 15min post injection. Having had mu...
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Vagal presyncope. Tachycardia. Cold sweat, lightheadedness about 15min post injection. Having had multiple vagal episodes before, including with other vaccines, I oncreased my SVR by kneeling down. Symptoms resolved after 15min of continuous kneeling.
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| 39 | 2021-01-07 | chills |
chills and body aches starting at 3:30 am lasting throughout the day. injection site soreness and ax...
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chills and body aches starting at 3:30 am lasting throughout the day. injection site soreness and axillary lymph node soreness
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| 39 | 2021-01-07 | fatigue, chills, cold sweat |
extremities were still cold with occasional tingling; hands and feet were very cold and arms and leg...
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extremities were still cold with occasional tingling; hands and feet were very cold and arms and legs were cold and clammy; hands and feet were very cold and arms and legs were cold and clammy; feeling tired with some chills; feeling tired with some chills; nausea; vomiting; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 02Jan2021 08:00 at single dose at left arm for covid-19 immunization. Medical history included arthritis, hip replacement, calcified DVT. Concomitant medication within 2 weeks of vaccination included colecalciferol (VITAMIN D, gummies). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took acetylsalicylic acid (ASPRIN) and experienced allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient received the first dose on 02Jan2021 at 08: 00. At 14: 30, patient started feeling tired with some chills. By 0500 (as reported), patient was having nausea with vomiting. The next morning on 03Jan2021, patient woke at 07:00, patient still had nausea, but also, hands and feet were very cold and arms and legs were cold and clammy. It was 05Jan2021 now and patient still had nausea and extremities were still cold with occasional tingling. Patient didn't receive treatment for events. The report is considered non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events nausea and extremities were still cold with occasional tingling was not recovered, and outcome of other events was recovering.
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| 39 | 2021-01-07 | headache | headache, myalgia, nausea, vomiting, and facial swelling x3 days |
| 39 | 2021-01-08 | somnolence, dizziness |
About 3-5 minutes after I felt so out of it. I felt like I was under the influence of something. I...
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About 3-5 minutes after I felt so out of it. I felt like I was under the influence of something. I tried to read my email and the words were there but didn't have meaning. I had to drive home after my 15 minute observation and plugged my home address into my gps so I wouldn't get lost even though I drove home from Medical Center for years. I got home and laid down and slept for a couple hours and woke up fine. I felt ok the following day and was doing laundry around 6 pm and my arm stopped being sore and I got really dizzy and nauseated and my vision had shadows (reminded me of an ocular migraine) and drank 2 x 16 oz glasses of water and laid down and felt better in about 20-30 minutes.
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| 39 | 2021-01-08 | fatigue, headache |
Extreme fatigue, slight headache...otherwise I feel fine, but the fatigue has made it hard to do thi...
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Extreme fatigue, slight headache...otherwise I feel fine, but the fatigue has made it hard to do things.
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| 39 | 2021-01-08 | headache | Headache Narrative: |
| 39 | 2021-01-08 | headache, throat pain, fatigue |
I have had the "normal" reactions such as; sore arm, ear and throat pain, headache, fatigue, and bod...
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I have had the "normal" reactions such as; sore arm, ear and throat pain, headache, fatigue, and body aches. I have also noticed my neck hurting and this am I notice a knot like form on my left clavicle bone that was not there prior to the the vaccine. I have not had any treatment for this.
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| 39 | 2021-01-08 | fatigue, headache, throat pain, dizziness |
No treatment needed yet. Headache, sore throat, dizzy, fatigue temp 99.4, bilateral arms and feet pa...
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No treatment needed yet. Headache, sore throat, dizzy, fatigue temp 99.4, bilateral arms and feet painful pins and needle sensation.
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| 39 | 2021-01-08 | somnolence, headache, fatigue, weakness |
Pt experienced extreme fatigue and sleepiness the day following her second vaccination for Covid 19 ...
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Pt experienced extreme fatigue and sleepiness the day following her second vaccination for Covid 19 and was found by her family after collapsing on 1/6/21 at 05:30. Upon arousal, she experienced headache, vomiting, weakness, difficulty speaking and difficulty walking with lower extremity weakness. She was taken to urgent care and subsequently admitted for evaluation at hospital and found to have a normal chemistry, blood count, normal lumbar puncture and normal imaging of her neck and brain. Discharge summary notes 3/5 strength and hyporeflexia throughout. Pt had televisit consult with psychiatry and neurology. She is subsequently to be discharged to a Facility without explanation for her sudden onset of progressive lower extremity and vocal weakness. She is noted to have a history of shellfish allergy. She experienced mild symptoms after the first vaccination, but no neurologic or vascular symptoms at that time.
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| 39 | 2021-01-08 | fatigue, cold sweat, dizziness |
Reported feeling onset of dizziness, right side of eye vision change, flushed, and clammy about 7 mi...
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Reported feeling onset of dizziness, right side of eye vision change, flushed, and clammy about 7 minutes after dose #2 of vaccination. No hx of adverse vaccine response. Only seasonal allergies. High-risk pregnancy at 25 weeks. Hx of feeling dizzy when she gets up suddenly, otherwise, no other medical issues. V/S taken over 45 minutes with noted decrease in BPs which was not normal for her. Apple juice x3 given at increments of 15 minutes and finished 1 bottle of water. Reports feeling better and then s/s returned. States she feels tired during episodes and back to normal. Advised to be evaluated in ED since her drive was more than 55 minutes away from hospital. Agreeable and was transported to ED for observation. B/P: 9:51 110/58, 10:09 92/58, 10:25 91/49 HR: 9:49 63, 9:59 80, 10:09 80, 10:25 80 SpO2: 9:49 99, 09:59 99, 10:09 99, 10:25 97 No other interventions given. Wheeled to the ED, room 505 at 10:41. Report given to RN.
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| 39 | 2021-01-08 | nasal congestion, throat pain, influenza like illness |
tachycardia (130-140's), HTN 140/100's, near syncope, nausea, temp 99.0 within minutes. That evening...
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tachycardia (130-140's), HTN 140/100's, near syncope, nausea, temp 99.0 within minutes. That evening face rash and itching. Following day flu like symptoms as well as sore throat and congestion.
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| 39 | 2021-01-09 | chills, fever |
1/5/21 started with fever (up to 101), severe body aches, shaking from being cold even bundled with ...
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1/5/21 started with fever (up to 101), severe body aches, shaking from being cold even bundled with electric blanket, nausea and vomiting. That lasted through 1/8. On 1/7 I started having trouble with taking a deep breath. Chest would get very tight and hurt when I would take a big breath, bend forward, or lay back. I went to express care and they could not rule out pericarditis. Told me to go to the Emergency Room for further work up to rule out spontaneous PE or pericarditis.
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| 39 | 2021-01-09 | dizziness |
15 minutes post injection, I was tachycardic, lightheaded, nearly fell over (nurse caught me as I st...
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15 minutes post injection, I was tachycardic, lightheaded, nearly fell over (nurse caught me as I started to sway), and my throat felt thick like something was stuck in it. Staff sat me into a recliner and called an ICU attending. Benedryl IM was given. Throat symptoms did not get worse but did take about 10-12 hours to resolve.
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| 39 | 2021-01-09 | headache, chills |
Day 2 Friday: Headache, Chills, Vertigo, severe Nausea & Vomiting; Treatment: Esgic for Headache, Zo...
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Day 2 Friday: Headache, Chills, Vertigo, severe Nausea & Vomiting; Treatment: Esgic for Headache, Zofran for N&V Day 3 Saturday: Headache, Fever 101.1, Severe N&V; Same treatment Day 4 Sunday: Moderate N&V with mild headache, no fever, Treatment: Zofran
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| 39 | 2021-01-09 | fever | Fever 100.5, muscle aches, joint pain lasting 24 hours |
| 39 | 2021-01-09 | fever | Fever 101.4 Arm sore |
| 39 | 2021-01-09 | headache, fever, chills | Fever, chills, vomiting, abdominal pain, headache |
| 39 | 2021-01-09 | fatigue, fever, headache, chills, weakness | Fever, chills, weakness, fatigue, headache |
| 39 | 2021-01-09 | headache, fatigue, malaise | Headache, fatigue, body ache, malaise |
| 39 | 2021-01-09 | chills, headache |
Hypotension and presyncope within 2 min of receiving the vaccine Tingling on face and both hands las...
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Hypotension and presyncope within 2 min of receiving the vaccine Tingling on face and both hands lasted for 2 hrs Following day- chills and abd cramping Day 3 -headache
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| 39 | 2021-01-09 | headache, fatigue, fever, dizziness |
My symptoms began approximately 14 hours after I received the vaccine. They started suddenly and in...
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My symptoms began approximately 14 hours after I received the vaccine. They started suddenly and included the following: -Intense dizziness that was also electric like and lasted 36 hours -Severe headache lasted 36 hours and mild for 48 hours -Fever last was intermittent for 48 hours. I only started recording it 24 hours after the vaccine was administered. My max temp was 101. -Nausea (1 episode of vomiting) lasted 36 hours -Muscle aches and joint pain lasted 36 hours -Extreme fatigue lasted 48 hours -Injection site pain and swelling are still present, but are now mild -Enlarged lymph node in armpit of the same arm that vaccine was administered. This was discovered about 24 hours after receiving the vaccine and is still present. It?s about 1 inch in diameter.
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| 39 | 2021-01-09 | dizziness |
Nausea, dry heaves, hot, dizziness after 12 minutes . Observed for 40 minutes. Gave water and snac...
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Nausea, dry heaves, hot, dizziness after 12 minutes . Observed for 40 minutes. Gave water and snacks. BP 121/83, HR 98. Resolved after observation. Husband picked up her.
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| 39 | 2021-01-09 | headache, chills, fatigue | Severe Headache, body aches, chills, fatigue, and metallic taste in mouth |
| 39 | 2021-01-09 | respiratory tract congestion |
Swelling in underarm on left side wher shot administered. Lasted less than 24 hours. Congestion and ...
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Swelling in underarm on left side wher shot administered. Lasted less than 24 hours. Congestion and tenderserness day 3-4, just over
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| 39 | 2021-01-09 | dizziness | dizziness moderate x 45 minutes and currently mild |
| 39 | 2021-01-10 | dizziness, fatigue |
1/8/21 Recieved vaccine. 1/9/21 started feeling dizzy, lightheaded, tired, body aches, right arm ly...
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1/8/21 Recieved vaccine. 1/9/21 started feeling dizzy, lightheaded, tired, body aches, right arm lymph nodes are swollen and tender. 1/11/21 flank pain and upper back pain woke her up today. 1/11/21 made appointment to be evaluated by provider.
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| 39 | 2021-01-10 | dizziness, fatigue, headache, fever, cough, chills |
10 minutes later, minor headache and itching. 4 hours later, lightheadedness/dizziness. ~12 hours la...
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10 minutes later, minor headache and itching. 4 hours later, lightheadedness/dizziness. ~12 hours later (03:30 the next day) fever up to 102, skin felt on fire all over my body, gi cramps, mild intermittent cough, myalgias, fatigue, extreme headache behind my eyes, occiput, and jaw pain, rigors.
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| 39 | 2021-01-10 | fatigue, headache |
About 6hrs after administration, a flat red splotchy rash that resembled a mottling pattern appeared...
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About 6hrs after administration, a flat red splotchy rash that resembled a mottling pattern appeared on both arms from shoulder to elbow, I had moderate pain in all joints of both legs, and severe fatigue came on suddenly. I had to go to bed. The next morning, I had a headache, all joints felt mildly aches, moderate fatigue, and the splotchy rash remained on both arms still from shoulder to elbow. I took ibuprofen and rested in bed most of the day.
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| 39 | 2021-01-10 | fatigue |
Arm pain at injection site. Fatigue and muscle aches for 24 hours. Swelling in armpit/lymph nodes on...
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Arm pain at injection site. Fatigue and muscle aches for 24 hours. Swelling in armpit/lymph nodes on injection site arm.
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| 39 | 2021-01-10 | chills, fatigue, fever |
Arm soreness Fever (99.6 F) (broke about 1/9/21 4 am) Chills Fatigue Took advil (400 mg) 1/9/21 @ ...
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Arm soreness Fever (99.6 F) (broke about 1/9/21 4 am) Chills Fatigue Took advil (400 mg) 1/9/21 @ 2 am and another 400 mg on 1/9/21 at 5:30 pm. Sxs did not recur since 1/10/21
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| 39 | 2021-01-10 | throat pain, headache | Body aches & severe joint pain, from shoulders down to toes, headache & neck pain, sore throat. |
| 39 | 2021-01-10 | fever | FEVER, CHILLS |
| 39 | 2021-01-10 | fever, chills, headache | Fever chills headache |
| 39 | 2021-01-10 | headache, cough, chills, fever |
Fever of 102, chills, rigors, myalgias, severe headache behind my eyes, occiput and jaw, intermitten...
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Fever of 102, chills, rigors, myalgias, severe headache behind my eyes, occiput and jaw, intermittent cough and gi cramping, along with feeling like my skin was on fire, especially on my face
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| 39 | 2021-01-10 | headache | GI upset , headache, chills, left side of body hurts |
| 39 | 2021-01-10 | fatigue, headache | Headache, joint pain, muscle aches and tiredness. |
| 39 | 2021-01-10 | throat irritation, chills, headache, discomfort |
I had a slight headache while at work but was fine. I was home and was a little cold and my throat w...
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I had a slight headache while at work but was fine. I was home and was a little cold and my throat was scratchy. . Then about 9pm all of a sudden I started to get waves of chills. My hand were cold and my feet were frozen. I layered up with sweater and sweatpants to go to bed with a heavy comforter. I just could not get warm. About 1am, I woke up and put on my thick winter socks on because my feet were still frozen. I kept reminding myself to breathe in deeply. I checked my BPM and it was 80-82 and normally its about low 70s. I woke up about 5:30am and had a really bad headache, injection area and arm hurt, my body hurt and felt like I weighed several tons making me so slow. I didn't go to work the next day. My husband took my son to school and I took ibuprofen and went back to bed. Woke up again about 12:30 and felt better.
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| 39 | 2021-01-10 | headache, fever |
I had an expected immune response, low grade fever, headache and body aches, all the resolved within...
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I had an expected immune response, low grade fever, headache and body aches, all the resolved within 10 hours. I only feel the need to report them as they coincided with my first injection rather than my second injection. I am curious if that is because I had COVID 19 in 4/2020 and therefore my immune system was already primed to respond. If it turns out to be a pattern, I think it would be helpful for others who have already had the disease to be given a heads up before their first injection. Thanks for all the work you do!
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| 39 | 2021-01-10 | fever |
I received my vaccine at 8:40 am on 1/6/20. By that evening I noticed I was having decreased urine o...
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I received my vaccine at 8:40 am on 1/6/20. By that evening I noticed I was having decreased urine output. Starting Thursday morning I had very minimal urine output for18 hours. I also had flank pain. During this time I also had a fever, body aches, etc. I am an ED nurse and knew to hydrate myself. I hydrated all day and evening. Thursday night I had no urine output for 6+ hours. Starting Friday morning I had minimal urine output and it was brown tinged. As the day progressed my output increased slowly and changed from brown to pink/orange. I continued to hydrate drastically. Saturday morning my urine was pale yellow and clear and my pain was gone. I believe I had an acute kidney injury. Fortunately I knew to drastically hydrate and maintain that.
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| 39 | 2021-01-10 | fever, fatigue | Lower back pain, fever, fatigue. |
| 39 | 2021-01-10 | dizziness |
My tongue became tingley, numb. My heart started to race and I became dizzy. The numbness has affe...
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My tongue became tingley, numb. My heart started to race and I became dizzy. The numbness has affected the right side of face and throat.
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| 39 | 2021-01-10 | headache, fever, fatigue, chills |
Nausea, body aches, fever chills, left arm pain, left axilla pin with adenopathy. Fatigue. Headache...
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Nausea, body aches, fever chills, left arm pain, left axilla pin with adenopathy. Fatigue. Headache.
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| 39 | 2021-01-10 | headache, dizziness |
Post first dose of pfizer covid vaccine I had 2-3 days of intermittent headaches starting approximat...
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Post first dose of pfizer covid vaccine I had 2-3 days of intermittent headaches starting approximately 4 hours after dose and also 4-5 days of intermittent lightheadedness. I developed redness at injection site 4 days post dose and it is still present as of today even though it seems to be fading. Site is still painful to the touch.
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| 39 | 2021-01-10 | nasal congestion, throat irritation, runny nose |
Redness and itchiness to chest and lower neck around nose as well as minor tongue swelling. I was va...
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Redness and itchiness to chest and lower neck around nose as well as minor tongue swelling. I was vaccinated at 0710, waited my 15 minutes drove home ( 15 min) showered and then just before 9 am realized Inwas itchy. Checked chest area and had red blotches similar in pattern to an anaphylactic reaction I had a few years earlier to betadine exposure. The night of the vaccine Inwoke up with nasal congestion and rhinorhea, itchy ears and throat, watery eyes. This became worse throughout the following day where I continued benadryl 50mg q6 as well as alternating tylenol and ibuprofen for body aches
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| 39 | 2021-01-10 | headache |
Within an hour of the injection patient broke out in hives followed by numbness and tingling on the ...
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Within an hour of the injection patient broke out in hives followed by numbness and tingling on the left side of the face. Mild headache with body soreness started approximately 8 hours after injection and lasted for about 12 hours. Benadryl was taken to relieve the hives, Advil and Tylenol were alternated to relieve headache and body soreness. The numbness of the face was resolved about 12 hours after onset.
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| 39 | 2021-01-10 | headache, dehydration |
developed UTI very quickly; Puffy face and eyes; Puffy face and eyes; Burning inside digestive tract...
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developed UTI very quickly; Puffy face and eyes; Puffy face and eyes; Burning inside digestive tract; Diarrhea; Dehydrated; arm pain; Headache; At bedtime neck stiffness began and worsened; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246/expiration date unknown), dose number 1, via an unspecified route of administration on 02Jan2021 10:30 at a single dose on the left arm for COVID-19 immunization. The patient had no relevant medical history. Concomitant medications included alprazolam (XANAX). The patient experienced arm pain and headache 4 hours post injection requiring Excedrin. At bedtime, neck stiffness began and worsened. She was treated with lidocaine patches and Aleve. She developed diarrhea 33 hours post injection. She went ER because she was dehydrated. She developed UTI very quickly by hour 35 post injection. She had puffy face and eyes, and burning inside her digestive tract. She was treated with Benedryl at home for allergic reaction, Toradol for pain, IV fluids for dehydration and Keflex for infection. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 since vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Dehydration cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 39 | 2021-01-10 | sweating, fever, fatigue, chills |
fatigue, chills, sweating, nausea, 99.1 fever then progressed to a 103 fever, severe pain in legs, t...
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fatigue, chills, sweating, nausea, 99.1 fever then progressed to a 103 fever, severe pain in legs, took Tylenol and brought fever down to 101.7. Next day, woke up to sunburn rash on face, trunk to groin and legs, fatigue lasting all day. Next day 1/9, rash was still there, fever reached 100 lasting all day and fatigue.
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| 39 | 2021-01-11 | somnolence |
1/11/21 at 0625 recieved vaccine. Had taken benadryl to help sleep due to working night shift. Wok...
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1/11/21 at 0625 recieved vaccine. Had taken benadryl to help sleep due to working night shift. Woke up at 2:30pm and noticed swelling to face and inside of inner cheeks. Went to Free Standing ER and recieved Hydroxyzine to help reduce swelling and sent home. 1/12/21 this am noticed the swelling in cheeks was better but now has swollen necks glands and facial swelling is slightly better in cheek better, but lips and rest of face of face still swollen.
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| 39 | 2021-01-11 | chills, headache, fatigue, dizziness |
Arm pain on the Injection site radiating to the left Armpit 3-4 hours after injection. Headache, ch...
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Arm pain on the Injection site radiating to the left Armpit 3-4 hours after injection. Headache, chills, Nausea, dizziness and fatigue for 2 days. January 10 is second covid vaccine date and January 12th woke up with a swollen left Armpit close to the breast. Left axillary lymph node swollen ? Not sure until I see a doctor. Will go to ER or Immediate Care to get it checked out.
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| 39 | 2021-01-11 | chills, fever, malaise | Arm soreness Fever Malaise Chills Body aches |
| 39 | 2021-01-11 | fever, chills | Chills, low grade fever up to 100.4, muscle aches, flushing red skin of neck and chest. |
| 39 | 2021-01-11 | headache |
Client c/o having blurry vision and splitting headache. Also felt very hot. Loss of consciousness....
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Client c/o having blurry vision and splitting headache. Also felt very hot. Loss of consciousness. Able to respond to verbal commands.
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| 39 | 2021-01-11 | nasopharyngitis, malaise, cold sweat |
Cold, clammy, fast HR rate of 143, just didn't feel well could find words to describe it and shaky. ...
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Cold, clammy, fast HR rate of 143, just didn't feel well could find words to describe it and shaky. Left hand numbness opposite site of injection site. Set to ED to be evaluated
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| 39 | 2021-01-11 | headache, fever, chills, fatigue |
Fever (Tmax 100.7), chills, myalgias, fatigue, nausea, headache. Worst symptoms lasted 12 hours. Fev...
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Fever (Tmax 100.7), chills, myalgias, fatigue, nausea, headache. Worst symptoms lasted 12 hours. Fever broke by evening. Next day at work still fatigue and myalgias. Had to leave 3 hours early. No pregnancy complications yet.
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| 39 | 2021-01-11 | fatigue, fever, chills |
Fever 100.8 after Tylenol for 10-24 hours post vaccination. , extreme chills, shaking, waking from s...
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Fever 100.8 after Tylenol for 10-24 hours post vaccination. , extreme chills, shaking, waking from sleep. Severe fatigue, unable to work for 2 days post vaccination. Unable to do daily activities. 24 hours after vaccination fever resolved, temp elevated 99.5-99.8, fatigue is mild to moderate.
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| 39 | 2021-01-11 | dizziness | Flushing dizziness and nausea |
| 39 | 2021-01-11 | headache |
Headache started 24 hours after vaccine lasted 2 days, diarrhea started about 36 hours after vaccin...
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Headache started 24 hours after vaccine lasted 2 days, diarrhea started about 36 hours after vaccine and lasted about 12 hours.
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| 39 | 2021-01-11 | headache | Headache, nausea, left arm pain |
| 39 | 2021-01-11 | headache |
Injection site soreness and headache started on the evening of the day shot was given. The injectio...
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Injection site soreness and headache started on the evening of the day shot was given. The injection site pain was worse the next morning but Tylenol took care of the pain. The headache continued on despite tylenol & ibuprofen, and accompanied by nausea for 4 days, went away for 3 days then came back again until present.
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| 39 | 2021-01-11 | chills, fever |
Nausea; Jumpiness; body aches; Chills; arm hurting; Fever; This is a spontaneous report from a conta...
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Nausea; Jumpiness; body aches; Chills; arm hurting; Fever; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231/expiration date Apr2021), dose number 1, via an unspecified route of administration on 04Jan2021 14:30 at a single dose on the left arm for COVID-19 immunisation. The patient had no relevant medical history. The patient previously had a flu shot for immunization and experienced fever, body aches, jumpiness, and arm hurting. She had no concomitant medications. She did not have any vaccination within 4 weeks prior the administration of the suspect vaccine. The patient was reporting side effects with the Pfizer vaccine. The events started in the morning of 05Jan2021 with the feeling of nausea. She also experienced jumpiness. In the evening, she had body aches, chills, and arm hurting. She also had fever, but it was not a very high fever. She took Tylenol on 05Jan2021 and on 06Jan2021, she had no body aches or fever yet. She felt much better on 06Jan2021. Her second dose is scheduled on the 25Jan2021. The patient received the vaccine at a workplace clinic. The outcome of the event was recovering.
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| 39 | 2021-01-11 | malaise, dizziness |
Patient developed throat tightening. Lightheaded, not feeling well. Administered diphenhydramine 5...
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Patient developed throat tightening. Lightheaded, not feeling well. Administered diphenhydramine 50 mg po once.
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| 39 | 2021-01-11 | fever, dizziness |
Pt had immediate dizziness, followed by fever of 101 the next day, followed by intermittent dizzines...
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Pt had immediate dizziness, followed by fever of 101 the next day, followed by intermittent dizzinesss since, which it now has been about a week, as well as nausea.
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| 39 | 2021-01-11 | sweating |
Received IM injection, 5 minutes later she felt tingling down her left arm. Over the course of the ...
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Received IM injection, 5 minutes later she felt tingling down her left arm. Over the course of the afternoon it spread to her left jaw, neck, face and lips. She proceeded to be seen by UC. She took tylenol. She improved. She had nausea and seats as well. This is similar to the symptoms she had of covid the month previous.
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| 39 | 2021-01-11 | headache, chills |
Received the vaccine and the following day started experiencing aches, chills, nausea and headache. ...
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Received the vaccine and the following day started experiencing aches, chills, nausea and headache. An ERT (emergency response was called at work) ; however, there was no further treatment.
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| 39 | 2021-01-11 | headache, chills, thirst, fever, fatigue |
Shaking from chills and fever, extreme thirst followed by vomiting, moderate headache, body ache, ki...
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Shaking from chills and fever, extreme thirst followed by vomiting, moderate headache, body ache, kidney area pain. Fatigue following. Missed work the following day.
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| 39 | 2021-01-11 | fever |
Supraclavicular lymph node swelling on left side starting second day after vaccine and still present...
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Supraclavicular lymph node swelling on left side starting second day after vaccine and still present at 4th day post vaccine. Pain in the sternocleidomastoid muscle that is mild. Lymph node is tender. Did have fever 12 hours post shot of 102.3 max but none since. No other lymph nodes swollen.
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| 39 | 2021-01-11 | headache, chills |
Symptoms ? EE woke up at 01:00 with body aches, chills and HA. EE reports she went back to bed and ...
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Symptoms ? EE woke up at 01:00 with body aches, chills and HA. EE reports she went back to bed and when she woke up around 07:00 EE reports swelling and tenderness in L axilla region. EE reports complete resolution of body aches, chills and HA approximately 36 hours after vaccine. EE reports she continued with swelling and tenderness to L axilla region through today (1/12). Last day of work and shift - ? working today Home remedies? - rest and Tylenol (last dose Sunday 1/10 in the morning) Any improvement? ? improvement with time per EE Recommendation? EE encouraged to continue to monitor her symptoms and to call vaccine support line with further questions/concerns. EE verbalized back understanding and denied further questions at this time.
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| 39 | 2021-01-11 | fatigue, headache | The day after I had a sore arm, fatigue, headache. |
| 39 | 2021-01-11 | chills, fever |
developed muscle aches, fever, chills, and nausea approximately 15hours post vaccine. unable to rep...
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developed muscle aches, fever, chills, and nausea approximately 15hours post vaccine. unable to report to work the next day, symptoms resolved
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| 39 | 2021-01-11 | dizziness | dizziness, lightheadedness, tongue tingling |
| 39 | 2021-01-11 | fever, headache | fever 101.7 for around 24 hours, headache body aches, arm pain and swelling |
| 39 | 2021-01-11 | chills, fever |
intense chills; uncontrollable shaking; Could not get warm; Had trouble walking; Had trouble sleepin...
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intense chills; uncontrollable shaking; Could not get warm; Had trouble walking; Had trouble sleeping; Felt warm rest of night; Did not have a chance to take my temperature but probably had a fever; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration, at the left arm on Jan2021 09:15 at a single dose for COVID-19 immunization at a hospital. Medical history included obesity. Concomitant medications included ibuprofen (ADVIL), methylphenidate & unspecified multivitamins. The patient previously took tetracycline and experienced allergies. On 06Jan2021 01:00, the patient woke up with intense chills and uncontrollable shaking, could not get warm or stop the shaking, had trouble walking or holding a glass of water shaking was so intense. Patient took ibuprofen helped and symptoms improved after 1-2 hours. The patient also had trouble sleeping and felt warm rest of night. Did not have a chance to take her temperature but probably had a fever. Overslept and missed first work meeting. Patient felt ok by 06Jan2021, 9:30. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient recovered from the events on 06Jan2021, 9:30.
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| 39 | 2021-01-11 | fever, chills |
left arm is really sore; fever/100.7 degrees Fahrenheit; chills/ shivering; feeling cold; body aches...
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left arm is really sore; fever/100.7 degrees Fahrenheit; chills/ shivering; feeling cold; body aches; sick; she was shaking and shivering; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (left deltoid), on 05Jan2021 at 11:00, at a single dose for COVID-19 immunization and preventative (prophylaxis). The patient has no relevant medical history and has no concomitant medications. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient is a registered nurse (RN) and received her first dose of the Pfizer COVID-19 vaccine yesterday. She had side effects from it. Last night (05Jan2021) she was kind of sick, she experienced fever and chills. She was in bed and trying to get cozy, but she was shaking and shivering, she does not know the exact time she experienced these since she was in bed. She checked her fever at 4am and it was 100.7 degrees Fahrenheit. She took Tylenol this morning and she does not think she has a fever as of now. She felt better and but she was still cold but not like last night. She still has body aches, but she is better now, and her body aches were worse when she had the fever. Now that her fever was down, she feels better, she does not know if she feels better since she took the Tylenol. She stated that none of her coworkers got sick. She just wanted to know if she will get better and if these were normal. She hopes she gets better since she never gets sick. She also reported that her left arm was really sore, there is no swelling. When she moves her arm, she can feel it was hurting and she was not able to sleep on her left side. She did not feel pain when she received the injection, she felt the pain after in her left arm. The events did not require emergency or physician visit. Outcome of the event body aches was not recovered, for event "left arm is really sore" was unknown, while for the remaining events was recovering. The reporter assessed the events as non-serious and related to the vaccine.
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| 39 | 2021-01-11 | fever, chills |
mild body aches; After first dose I only had pain at the injection site. After the second dose of th...
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mild body aches; After first dose I only had pain at the injection site. After the second dose of the vaccine I had pain at the injection site as well as mild body aches, chills and a fever of 101.5.; After first dose I only had pain at the injection site. After the second dose of the vaccine I had pain at the injection site as well as mild body aches, chills and a fever of 101.5.; After first dose I only had pain at the injection site. After the second dose of the vaccine I had pain at the injection site as well as mild body aches, chills and a fever of 101.5.; This is a spontaneous report from a contactable nurse. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EJ1685, intramuscular at left arm from 16Dec2020 11:30 to 16Dec2020 11:30 at a single dose then (lot number: EK9231) via an unspecified route of administration at left arm from 05Jan2021 to 05Jan2021 at a single dose for COVID-19 immunization. Medical history included supraventricular tachycardia. Concomitant medication included propranolol. After first dose on Dec2020, the patient only had pain at the injection site. After the second dose of the vaccine on 06Jan2021, the patient had pain at the injection site as well as mild body aches, chills and a fever of 101.5. The patient dis not received any treatment for the adverse events. The outcome of th events was recovering.
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| 39 | 2021-01-11 | lethargy, weakness, chills, fatigue |
swollen lymph nodes at neck and sore to the touch; swollen lymph nodes at neck and sore to the touch...
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swollen lymph nodes at neck and sore to the touch; swollen lymph nodes at neck and sore to the touch; swollen and stiff neck; swollen and stiff neck; chills; hot flashes; radiating pain of arms; numb fingers; blue hands and feet; joint pain; muscle aches; weakness; tirednes; lethargic; This is a spontaneous report from a contactable Other Health Professional (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EL0140, via an unspecified route of administration in the left arm on 04Jan2021 16:45 at a single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, ADHD, overweight, asthma and known allergies to milk, cat, roach mix, dust mites and bermuda grass. Concomitant medication included levothyroxine sodium (SYNTHROID), fluoxetine hydrochloride (PROZAC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), trazodone and montelukast. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination nor was she tested for covid post vaccination. The patient experienced swollen lymph nodes at neck and sore to the touch, swollen and stiff neck, chills, hot flashes, radiating pain of arms, numb fingers, blue hands and feet, joint paint, muscle aches, weakness, tiredness, and was lethargic, all on 04Jan2021 at 17:30 PM with outcome of recovering. The events were reported as non-serious with no treatment received. No follow-up attempts are possible. No further information is expected.
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| 39 | 2021-01-12 | throat swelling |
10:33am Pt c/o difficulty swallowing, and swelling of throat. BP: 147/89 )02sat 99%RA, HR 91 Temp:3...
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10:33am Pt c/o difficulty swallowing, and swelling of throat. BP: 147/89 )02sat 99%RA, HR 91 Temp:36.8 RR :16 10:35am Benadryl 50mg IM given of Left deltoid 10:50am: Patient reassessed symptoms not progressing 11:15am: symptoms resolving
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| 39 | 2021-01-12 | chills, fatigue, headache, malaise, fever |
11 hours after vaccine, chills started. Fever, chills, severe headache and body aches, and fatigue ...
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11 hours after vaccine, chills started. Fever, chills, severe headache and body aches, and fatigue over next 24 hours. Bedridden, would not have been able to work or care for my children. Left eyelid began twitching at that time and has continued to have intermittent periods of twitching over the 5 days since.
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| 39 | 2021-01-12 | fatigue, fever, chills |
Called to report that the evening she received dose, she experienced extreme fatigue and body aches....
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Called to report that the evening she received dose, she experienced extreme fatigue and body aches. Woke up during night on 1/12 with fever, chills, joint pain and body aches. Spoke with her this morning 1/13 and reports feeling better today other than fatigue. Plans to return to work 1/14.
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| 39 | 2021-01-12 | fatigue, chills, headache | Chills, body aches, joint pain, headache, fatigue,nausea |
| 39 | 2021-01-12 | dizziness, lethargy, weakness |
Employee complained of dizziness after sitting for 10 min in observation area. Employee became letha...
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Employee complained of dizziness after sitting for 10 min in observation area. Employee became lethargic and was unable to stand. She complained of R side chest pain and R sided weakness. Symptoms did not go away. Employee sent to ER.
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| 39 | 2021-01-12 | fatigue, headache | Fatigue, joint aches, muscke aches, mild headache |
| 39 | 2021-01-12 | chills, headache, fever | Fever as high as 101.6, headache, chills, muscle pain, vomiting |
| 39 | 2021-01-12 | headache, fever, chills | Fever, chills, muscle ache, joint pain, bones ache, headache. |
| 39 | 2021-01-12 | chills, fever, malaise, influenza like illness, fatigue |
Fever, chills, tiredness, feeling unwell, flu like symptoms; Fever, chills, tiredness, feeling unwel...
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Fever, chills, tiredness, feeling unwell, flu like symptoms; Fever, chills, tiredness, feeling unwell, flu like symptoms; Fever, chills, tiredness, feeling unwell, flu like symptoms; feeling unwell; Fever, chills, tiredness, feeling unwell, flu like symptoms; dose 1 received on 17Dec2020 while dose 2 received on 05Jan2021; This is a spontaneous report from a non-contactable nurse (patient). A 39-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration on 05Jan2021 15:30 at single dose in her right arm for covid-19 immunization. Medical history included hypertension. Concomitant medications the patient received within 2 weeks of vaccination included metoprolol and hydrochlorothiazide. The patient had known allergies to lisinopril and had historical vaccine included her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 17Dec2020 15:30 in her right arm for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever, chills, tiredness, feeling unwell, flu like symptoms on 06Jan2021 15:30. The adverse events fever, chills, tiredness, feeling unwell, flu like symptoms result in any of the following included doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events fever, chills, tiredness, feeling unwell, flu like symptoms. The outcome of the events fever, chills, tiredness, feeling unwell, flu like symptoms was recovering.
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| 39 | 2021-01-12 | headache, chills, body temperature increased, fatigue | Increase body temperature of 100.0, chills, headache, fatigue on 12/27/20-12/29/20 |
| 39 | 2021-01-12 | chills |
Internal Hemorrhage (GI) & urinary Muscles aches chills (L) side pain after 2 days post COVID vaccin...
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Internal Hemorrhage (GI) & urinary Muscles aches chills (L) side pain after 2 days post COVID vaccine #1 & after 1 day post COVID vaccine # 2 Hemorrhoids, bright red blood per rectum. Saw GI doctor. C/o platelet count (low normal)
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| 39 | 2021-01-12 | dizziness |
Patient developed numbness in her lips, had some tachycardia, and dizziness around 5:30 pm. Patient ...
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Patient developed numbness in her lips, had some tachycardia, and dizziness around 5:30 pm. Patient then notified one of the physician who advised her to monitor symptoms and notify on call provider if symptoms worsened. Patient then went home and slept and the next morning was feeling better.
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| 39 | 2021-01-12 | fever |
Patient had the initial Pfizer COVID vaccine on December 18th. She started to having arthralgias, m...
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Patient had the initial Pfizer COVID vaccine on December 18th. She started to having arthralgias, myalgias, fever, fatigue and weakness starting on December 20th. The patient continuously had arthralgias, myalgias and weakness for the next few weeks. Patient follow up with physical therapist once a week to work on muscle weakness. The patient continuously had arthralgias and myalgias until January 10th. Primary care provider on January 7th orders CBC, autoimmune and thyroid panel since patient was having ongoing myalgias and arthralgias. Patient postpone 2nd dose because side effects from previous vaccine were ongoing. Patient got 2nd dose vaccine on January 12th at 4:30pm. On January 13th at 11am the patient initially had nausea and arthralgias. Patient took Zofran 4mg ODT about 11:15am. 30mins later the patient tongue swelled. No lips swelling and no SOB. Patient immediately took liquid Benadryl 50mg to 75mg PO. Patient immediately drove to ED. Patient was observed until 2pm for signs and symptoms of allergic reaction. Patient was discharge and advised to take Benadryl 25mg to 50mg every 4 to 6 hrs prn allergic reaction, Patient took famotidine 20mg at 4pm along with 25mg of Benadryl PO. Tongue swelling began to decrease. Patient also had fever, myalgia and arthralgias at 4:30pm. Took Tylenol 1,000mg and symptoms subsided (fever, myalgia and arthralgias).
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| 39 | 2021-01-12 | dizziness |
Patient received her shot on 1/13/2021 at 11:20am. 12 minutes later she started getting very dizzy....
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Patient received her shot on 1/13/2021 at 11:20am. 12 minutes later she started getting very dizzy. Her face was very red. She was extremely hot. Patient first bp was 140/101 with a pulse of 75. We continued to monitor her for the next 1 hour and 20 minutes until family arrived because she refused for us to call 911 because she did not want a bill. Every time we sat her up she was extremely dizzy. BP was 160/107 when she sat up on the bed. Her husband ended up taking her to the ER because she was still very hot and dizzy. Dr. was here. He listened to her breathing multiple times. There was no signs of allergic reaction. Patient reported a history of panic attacks.
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| 39 | 2021-01-12 | weakness, headache, lethargy, dizziness |
Severe body muscle and bone aches, nausea, episodes of feeling faint, Orthostatic hypotension, loss ...
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Severe body muscle and bone aches, nausea, episodes of feeling faint, Orthostatic hypotension, loss of color in face and lips, headache, weakness, lethargy
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| 39 | 2021-01-12 | body temperature increased, dizziness, headache |
Severe pain in Right shoulder and inability to move arm more that 10 degrees with shoulder flexion o...
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Severe pain in Right shoulder and inability to move arm more that 10 degrees with shoulder flexion of abduction, nausea, vomiting, dizzy (beginning to pass out), chest pain, temp over 102, severe headache
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| 39 | 2021-01-12 | fever, headache |
The day of vaccination developed fever and joint pain 24 hrs later nausea and diarrhea, 48 hrs later...
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The day of vaccination developed fever and joint pain 24 hrs later nausea and diarrhea, 48 hrs later headache and left hand numbness
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| 39 | 2021-01-12 | chills |
chills; get occasionally warmer but temperature is normal/feeling warm in her body or feverish but n...
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chills; get occasionally warmer but temperature is normal/feeling warm in her body or feverish but never had a temperature/ 99 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via unspecified route in the left arm single dose for COVID-19 immunization on 28Dec2020, 16:45 at 39-year-old. No medical history. Concomitant medication was not reported. No additional vaccines administered on same date of the vaccination or within 4 weeks before the vaccination. The patient had a little bit of chills on 31Dec2020. The chills was on and off, it may have even been on 01Jan2021. The patient occasionally felt warmer, but her temperature was normal. She felt warm inside her body or feverish on 29Dec2020 but never had a temperature. She still felt the chills and feverish on and off. She had it all day yesterday 05Jan2021. The temperature was 99 degrees Fahrenheit on 05Jan2021, but she had been working in the house. After she sat down for a while the fever went away. The chills and feeling like she might have fever are persisting through today. She didn't treat the chills or feverish in any way. No physician office or emergency room visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.
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| 39 | 2021-01-12 | chills, respiratory tract congestion, fever, headache |
developed mild head ache and body ache around 7 pm on 1/11/2021, worsened after 7:30 pm with chills ...
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developed mild head ache and body ache around 7 pm on 1/11/2021, worsened after 7:30 pm with chills and fever and severe body ache through the night with mild congestion and more pronounced head ache by 1/12/2021. Took Tylenol to reduce fever. Fever and chills returned as medication effect reduces over 6 hours, it has continued today on 1/13/21
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| 39 | 2021-01-12 | sweating, shortness of breath |
difficulty breathing, pale, rash on chest ,diaphoretic treated with diphenhydramine inj and dexame...
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difficulty breathing, pale, rash on chest ,diaphoretic treated with diphenhydramine inj and dexamethasone injection
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| 39 | 2021-01-12 | fever | fever, joint pain, nausea. called in sick to work. |
| 39 | 2021-01-13 | dizziness |
After second dose of Pfizer COVID-19 vaccine, patient experienced flushing/hot, dizziness, and light...
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After second dose of Pfizer COVID-19 vaccine, patient experienced flushing/hot, dizziness, and lightheadedness. Patient was given water/juice. Patient was instructed to wait an additional 15 minutes for observation but declined and left against medical advice
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| 39 | 2021-01-13 | fatigue |
After the 1st injection I started feeling a little nauseous for the rest of that day and the followi...
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After the 1st injection I started feeling a little nauseous for the rest of that day and the following. 24 hrs. after the vaccine I also felt extreme fatigue that required me to lay down and sleep for about an hour
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| 39 | 2021-01-13 | shortness of breath, throat pain |
Asthmatic reaction- breathing issues going on for upwards of 1 week. Completely out of breath and bu...
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Asthmatic reaction- breathing issues going on for upwards of 1 week. Completely out of breath and burning sensation when trying to breath. Severe sore throat Numb left had day of injection
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| 39 | 2021-01-13 | chills, fever, respiratory tract congestion | CHILLS, FEVER, AND CONGESTION. |
| 39 | 2021-01-13 | shortness of breath, weakness, chills, fever |
Fever; chills; SOB; pain while taking a deep breath; swelling/itchiness left arm; swollen lymph node...
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Fever; chills; SOB; pain while taking a deep breath; swelling/itchiness left arm; swollen lymph nodes on left side under arm; generalized weakness
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| 39 | 2021-01-13 | chills, headache |
H/A head is pounding, Chills shivering, took hours to warm up, nausea, 102.4temp, took Tylenol. Thi...
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H/A head is pounding, Chills shivering, took hours to warm up, nausea, 102.4temp, took Tylenol. This AM still have H/A, sore arm, 98.8 temp. Pain in right upper arm.
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| 39 | 2021-01-13 | headache |
Pain at injection site; body aches; headache; This is a spontaneous report from a contactable other ...
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Pain at injection site; body aches; headache; This is a spontaneous report from a contactable other health professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, on 06Jan2021 at SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Historical vaccine included BNT162B2, intramuscular from 16Dec2020 to 16Dec2020 (1st dose; lot: PAA156051). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. There were no concomitant medications. The patient experienced pain at injection site, body aches and headache. The outcome of event was recovering. No treatment received. No follow-up attempts possible. No further information expected.
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| 39 | 2021-01-13 | fever, chills |
Patient with fevers, chills a few days after vaccine. Additionally reporting lower GI bleeding with ...
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Patient with fevers, chills a few days after vaccine. Additionally reporting lower GI bleeding with no prior history. Patient received clearance for second vaccine from GI provider and undergoing further work-up for bleeding. Lab work demonstrating some decrease in platelets as well. Bleeding controlled after a few days.
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| 39 | 2021-01-13 | migraine |
Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Ras...
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Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH9899), intramuscular, in the left arm on 23Dec2020 at 10:30 AM (at the age of 39-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination was not reported. The patient previously took prochlorperazine edisylate (COMPAZINE) and experienced drug hypersensitivity. On 23Dec2020 at 8 PM, the patient experienced rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week. The events were reported as non-serious. The patient did not receive any treatment for the rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week. The clinical outcome of the events rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 39 | 2021-01-13 | fatigue, night sweats |
Sore arm; fatigue; night sweats; This is a spontaneous report from a contactable Other Health Profes...
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Sore arm; fatigue; night sweats; This is a spontaneous report from a contactable Other Health Professional (patient). A 39-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 22Dec2020 07:15 at a single dose for COVID-19 immunization at the hospital. Medical history included anxiety from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medications included ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), escitalopram oxalate (LEXAPRO), birth control and unspecified MVI. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm, fatigue and night sweats on 22Dec2020 with outcome of recovering. No treatment was given for the events. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on batch/lot number was requested.
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| 39 | 2021-01-13 | dizziness, sweating, shortness of breath |
Tingling, lightheaded, SOB, diaphoretic. Administered 50 IM Benadryl and symptoms were not resolvin...
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Tingling, lightheaded, SOB, diaphoretic. Administered 50 IM Benadryl and symptoms were not resolving. Called EMS for transport to ED.
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| 39 | 2021-01-13 | fatigue, headache, chills, fever |
Upper arms soreness; Upper arms soreness; Chills; Headache; lower stomach and lower back cramping; l...
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Upper arms soreness; Upper arms soreness; Chills; Headache; lower stomach and lower back cramping; lower back cramping; fever 102; Fatigue; joint and muscle pain; joint and muscle pain; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 39-year-old female patient (not pregnant) received the second dose of BNT162B2 (Pfizer BioNTech COVID-19 Vaccine), intramuscularly in left arm on 06Jan2021 08:00 AM at single dose for COVID-19 immunisation. Facility type vaccine was in hospital. Medical history included Sulfa allergy. There were no concomitant medications. The patient received the first dose of BNT162B2 on 16Dec2020 07:30 and experienced upper arms soreness. The patient didn't have other vaccine in four weeks or other medications in two weeks. The patient was not diagnosed with COVID-19 prior vaccination and didn't test COVID-19 post vaccination. After receiving the 2nd dose, the patient experienced upper arm soreness, chills, headache, lower stomach and lower back cramping, fever 102, fatigue, joint and muscle pain on 06Jan2021, 05:00 PM. No treatment was received for the events. Seriousness criteria was no. The outcome of the events was recovering. Information about lot/batch number has been requested.
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| 39 | 2021-01-13 | chills, fatigue, dizziness, fever |
Within minutes of getting the vaccine I had a brief(maybe 30 seconds) episode of dizziness. I didn't...
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Within minutes of getting the vaccine I had a brief(maybe 30 seconds) episode of dizziness. I didn't have any other symptoms during my 15 min observation period, but when I got to my car to leave the hospital, I had another episode of dizziness that lasted a couple minutes and then stopped. I didn't have any other incidents of dizziness, but started feeling fatigued and had chills that afternoon. Tuesday evening I had a slight fever, diarrhea, tachycardia, and palpitations. Over night I developed body aches. Most of the symptoms were pretty much gone within 24 hrs, but the fatigue and tachycardia lasted into Friday. My heart rate was consistently 115-125 bpm from Tuesday evening through Friday.
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| 39 | 2021-01-13 | fever, fatigue, headache |
felt kind of tired; Tested positive for COVID after receiving the first dose of the COVID Vaccine; T...
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felt kind of tired; Tested positive for COVID after receiving the first dose of the COVID Vaccine; Tested positive for COVID after receiving the first dose of the COVID Vaccine; slight fever; body aches; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (the patient) reported that a 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730) via unspecified route of administration on the left arm/shoulder on 22Dec2020 at single dose for COVID-19 immunisation. Medical history included gained weight since the pandemic started. The patient's concomitant medications were not reported. Patient received first dose of the vaccine. She had symptoms right after she got the vaccine the next day, on 23Dec2020. She had a slight fever, body aches, and a headache, which she never gets. She had these for about 2-3 days, they lingered around, and kicked back up around 26Dec2020/27Dec2020. She also felt kind of tired. She got covid 19 infection tested on 02Jan2021 and the results came back positive on 03Jan2021. Patient was calling to report this and see what to do about the second dose. She was supposed to get her second dose next Tuesday. The outcome of events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
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| 39 | 2021-01-13 | headache |
rash developed on 50% of her body; vomiting; nausea; headache; severe muscle aches; This is a sponta...
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rash developed on 50% of her body; vomiting; nausea; headache; severe muscle aches; This is a spontaneous report from a contactable nurse reported for herself. This 39-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via Intramuscular at left arm on 16Dec2020 at 01:00 PM at single dose (lot number: EK5730) for COVID-19 immunisation. Medical history was unknown. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), zolpidem tartrate (AMBIEN) and vitamins. The patient previously took dicycloverine hydrochloride (BENTYL), amlodipine and azithromycin (ZITHROMAX), all experiencing allergies. The patient experienced rash developed on 50% of her body, vomiting, nausea, headache, severe muscle aches 24 hours post vaccination on 17Dec2020 10:45 AM. The patient was treated with Benadryl, Tylenol, IM Solumedrol. The patient had Covid test post vaccination by Nasal Swab on 28Dec2020 and on 04Jan2021, both with negative results. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of all events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the rash and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 39 | 2021-01-13 | cough |
tested positive/had the COVID infection/cough; tested positive/had the COVID infection/cough; PFIZER...
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tested positive/had the COVID infection/cough; tested positive/had the COVID infection/cough; PFIZER-BIONTECH COVID-19 VACCINE at 1.3 mL; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 19Dec2020 at 1.3 mL, single for COVID-19 immunization. There were no medical history and concomitant medications. She received the first COVID-19 vaccine dose on 19Dec2020 then she tested positive on 22Dec2020. She got the first dose of the COVID vaccine and now she had the COVID infection. She was wondering if she should continue to get the second dose. She was also wondering if it will affect whether or not she gets the second dose. She couldn't find information online about what to do. Before she got the vaccine, she did take a test on an unspecified date to make sure she was negative, and she was. She had a cough at the end of the call. Outcome of the events was unknown. Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 39 | 2021-01-14 | chills, headache, fatigue |
2ns shot -- headache that started shortly after the shot that worsened and was not alleviated with t...
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2ns shot -- headache that started shortly after the shot that worsened and was not alleviated with tylenol. headache lasted about 1.5 days. chills started at about 3 am on 1/13/2021 and lasted for about 1 day. body aches lasted for one day on 1/13. fatigue started on 1/13 and lasted through 1/14. painful left axillary lymph node swelling starting on 1/13 and continuing to present day. 1st shot -- sore arm, painful left axillary lymph node swelling
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| 39 | 2021-01-14 | fever, chills |
After second dose, extreme chills and shivering that lasted 2.5 hrs. Temperature of 100.1F; After se...
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After second dose, extreme chills and shivering that lasted 2.5 hrs. Temperature of 100.1F; After second dose, extreme chills and shivering that lasted 2.5 hrs. Temperature of 100.1F; This is a spontaneous report from a contactable Consumer (patient). This 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL3248/expiration date: unknown), via unknown route of administration, on 08Jan2021 at 07:15 AM (at the age of 39 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history was unknown. The patient had known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS). The patient previously received the first dose of BNT162B2 (lot number: Eks5730/expiration date: unknown) on 18Dec2020 at 02:45 PM (at the age of 39 years old) as a single dose in the left arm via unknown route of administration for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Jan2021 at 09:30 PM, after the second dose, the patient experienced extreme chills and shivering that lasted 2.5 hrs with temperature of 100.1F. The patient took ibuprofen and temp went down. Then give or take a few hours, the temperature was rising again. The patient stated that she is " self-medicating currently and hope it does not get worse". Treatment was received for the events extreme chills and shivering included ibuprofen. The outcome of the events extreme chills and shivering was not recovered. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19.
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| 39 | 2021-01-14 | fever, chills | CHILLS,FEVER AND ANXIUS. |
| 39 | 2021-01-14 | dizziness | DIZZINESS, HEART RACING |
| 39 | 2021-01-14 | headache |
Moderate Bilateral jaw pain with moderate headaches; started about 3-4 days after shot, persistent, ...
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Moderate Bilateral jaw pain with moderate headaches; started about 3-4 days after shot, persistent, constant- despite ice and ibuprofen. Pain is intense but manageable to go to work. I am getting really worried about this pain. No problem increased pain with eating, but or talking
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| 39 | 2021-01-14 | fatigue |
Muscle pain, from lower back down.; I had no feeling at all below the waist; fatigue; Muscles would ...
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Muscle pain, from lower back down.; I had no feeling at all below the waist; fatigue; Muscles would feel like they were seizing up and clenching throughout the night; This is a spontaneous report from a contactable nurse. A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration in left arm on 07Jan2021 18:30 at a single dose for COVID-19 immunization. The vaccine was administered in a hospital. Medical history included Von Willebrand's disease. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ibuprofen. On 07Jan2021 23:00, the patient experienced muscle pain, from lower back down, Muscles would feel like they were seizing up and clenching throughout the night, for a short time she had no feeling at all below the waist and incredible fatigue. The outcome of the events was not recovered. The patient was not tested for COVID-19 post vaccination. The events was assessed as non-serious by the nurse. The patient did not received any treatment for the events.
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| 39 | 2021-01-14 | fatigue, headache, fever, dizziness |
Nausea; vomiting; dizziness with vertigo; dizziness with vertigo; headache; fever; severe body aches...
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Nausea; vomiting; dizziness with vertigo; dizziness with vertigo; headache; fever; severe body aches in lower back; fatigue; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246), via intramuscular on 07Jan2021 11:45 at single dose in left arm for covid-19 immunization. Medical history included asthma, hospitalized with pertussis related bronchiolitis/hypoxia in Apr2020. The patient's concomitant medications received within 2 weeks of vaccination included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergies to medications, food, or other products included erythromycin and pancuronium bromide (PAVULON). The patient previously received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), via intramuscular on 17Dec2020 17:00 at single dose in right arm for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The patient experienced nausea, vomiting, dizziness with vertigo, headache, fever, severe body aches in lower back and fatigue from 36 to 50 hours post vaccination on 09Jan2021. The patient did not receive any treatments. The outcome of the events was recovered in Jan2021.
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| 39 | 2021-01-14 | fatigue |
Slight joint pain in hips at 0700 on 1/9/21 progressing to severe pain in hips, back, and neck by 12...
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Slight joint pain in hips at 0700 on 1/9/21 progressing to severe pain in hips, back, and neck by 1200. Unable to move without pain rated 9/10. Tylenol and Motrin used PRN. Also noted fatigue and redness, swelling, pain at injection site. Called in to work 1/9/21 and 1/10/21. Pain continued rated at 8/10 until 1/12/21 when patient visited Urgent Care at 0930 . Provider gave 10mg oral Decadron and 30mg Toradol IM. Oral prednisone 50mg prescribed for 3 days starting 1/13/21. And continue regiment of tylenol, motrin, heat, bath for relief of symptoms. 1/13/21 patients lower back pain resolved. 1/14/21 patients left hip pain resolved. Right hip pain continues at same intensity, though somewhat more controlled with PRN tylenol, motrin, heating pad. Unable to work as of the submission of this report.
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| 39 | 2021-01-15 | headache, fatigue, body temperature increased, chills |
Chills, headache, nausea at 2:00am, temp 101.3 at 4:30am with headache, body ache, nausea, fatigue. ...
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Chills, headache, nausea at 2:00am, temp 101.3 at 4:30am with headache, body ache, nausea, fatigue. Temp 101.4 at 10:30am with headache, body ache, nausea, fatigue. Temp 101.7 at 4:30pm with headache, nausea, body ache, fatigue.
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| 39 | 2021-01-15 | shortness of breath | Swollen tongue and sob with decreased swallow |
| 39 | 2021-01-16 | chills, fatigue |
Approximately 15 hours after I received my second COVID-19 vaccination I developed chills and body a...
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Approximately 15 hours after I received my second COVID-19 vaccination I developed chills and body aches, which woke me up from sleep. When I woke up in the morning I had extreme fatigue; even walking to the bathroom was a challenge. I spent most of the day in bed, unable to do my normal daily activities. These symptoms lasted approximately 18 hours then completely resolved.
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| 39 | 2021-01-16 | weakness, fatigue |
Immediately after the shot, felt very weak. took two tablets of Tylenol 500mg and went to bed. slept...
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Immediately after the shot, felt very weak. took two tablets of Tylenol 500mg and went to bed. slept for 9 hours. the next day began itching around the middle - stomach and back had to work so did not take anything for it. by the second day the itching was generalized. only temporarily relieved by application of cortisone - 10. the 3rd day I took cetirizine but it didn't seem to help much. the 4th day I took Benadryl and the itching reduced for the next few days. took another Benadryl on the 7th day. itching more localized to the stomach and back. Today, it came back to generalized again. from the scalp to the soles of the feet. I have to work so cannot take Benadryl at this time. Thought I would not need to see the Dr, hoping it would get better but as it stands today I will need to go see the Dr.
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| 39 | 2021-01-16 | cough, weakness, migraine, headache, fatigue, shortness of breath, dizziness |
Sore arm at the injection site 24 hours post vaccine then symptoms of nausea, weakness, tired, head...
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Sore arm at the injection site 24 hours post vaccine then symptoms of nausea, weakness, tired, headache started 12/20/2020, 4 days post the vaccine. Went to the ER on the 12/21/20-12/22/20 due to increase headache, vomiting, diarrhea, dizzy, dry cough, weak/extremely fatigue. At the ER was given IV fluid, Zofran, Phenergan, tested for the Flu and Covid, also had blood work. All my blood work came back in normal ranges, FLU and Covid test were negative as well. Discharged from the ER with Phenergan, the next 3 days I had a migraine and had to be in a dark room with lights off, still very dizzy, tired, shortness of breath with movement, could not eat it made me nauseas. Called for follow up with PCP he then put me on steroids, for 7 days. 12/28 called PCP office again, was put on another round of steroid treatment with antibiotic. Was off work from 12/21/2020-01/02/21 due to the sickness post the vaccine
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| 39 | 2021-01-17 | fatigue |
Ache and discomfort in right shoulder, neck, and upper back accompanied with extreme swelling of rig...
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Ache and discomfort in right shoulder, neck, and upper back accompanied with extreme swelling of right axilla that is sensitive to palpation. Extreme fatigue was also noted for 2 days following vaccination. Treatment included alternating doses of Tylenol 500mg and Advil 400mg, heat compress, and lymph massage. Swelling and other symptoms resolved 48hrs after they began.
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| 39 | 2021-01-17 | fever, fatigue, headache | Headache, muscle/body aches, hot and cold flashes, fatigue, and low grade fever. |
| 39 | 2021-01-17 | chills, headache | Nausea, body aches, extreme cold chills then hot flashes, heachache |
| 39 | 2021-01-18 | headache, fatigue, shortness of breath, cough |
severe headache behind the eyes; Initially extreme fatigue; started to have shortness of breath; mus...
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severe headache behind the eyes; Initially extreme fatigue; started to have shortness of breath; muscle aches; cough; second dose on 05Jan2021 08:30; This is a spontaneous report from a contactable physician (patient). A 39-year-old female patient received second dose of BNT162B2 (Lot number: EL3246), intramuscularly on 05Jan2021 08:30 in left arm at single dose for COVID-19 immunization. Medical history included known allergies: latex and asthma. Patient did not have COVID prior vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), drospirenone/ethinylestradiol (YASMIN), melatonin, and ibuprofen (MOTRIN). Patient previously took montelukast sodium (SINGULAIR) and experienced allergy. Patient received first dose of BNT162B2 (Lot number: EK5730), intramuscularly on 18Dec2020 09:00 in left arm at single dose for COVID-19 immunization. Patient experienced initially extreme fatigue, then muscle ached all within 12-24 hours, severe headache behind the eyes. Then when thought was getting better, she started to have shortness of breath, worsening fatigue, and cough; all on 05Jan2021 12:00. These events were resulted in emergency room/department or urgent care. COVID was tested post vaccination. COVID test type post vaccination was nasal swab. COVID test name post vaccination was COVID 19 nasopharyngeal swan. COVID test date was on 08Jan2021. Test result was pending. Treatment received included nebulizer treatment, and steroid course. Patient was not recovered from these events.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile, causality between events severe headache and extreme fatigue and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 39 | 2021-01-19 | head discomfort, dizziness |
39yo female with no documented allergies c/o being dizzy post vaccination with COVID19 Pfizer BioNTe...
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39yo female with no documented allergies c/o being dizzy post vaccination with COVID19 Pfizer BioNTech vaccine dose #1. No supportive treatment nor antidote given. Continued to state that she has mild pressure to her head. Ambulated without problem discharged to self.
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| 39 | 2021-01-19 | fatigue |
Around 12 hrs later, I started feeling general fatigue, chills, no fever and achy all over. Didn't ...
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Around 12 hrs later, I started feeling general fatigue, chills, no fever and achy all over. Didn't sleep well. I didn't take any meds since I'm pregnant. Symptoms peaked around 26 hours after vaccine. I slept almost all day. A very deep sleep. I started to feel a little better gradually. At 36 hours, I was completely back to normal. I am currently 31 weeks. I was 29 when I received the vaccine. Even with everything I experienced, I would do it again.
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| 39 | 2021-01-19 | chills, fever, fatigue, headache |
Began having chills, fever 101.6, dry mouth, headache and body ache. Took ibuprofen and fever subsid...
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Began having chills, fever 101.6, dry mouth, headache and body ache. Took ibuprofen and fever subsided. Still having chills and extreme fatigue. Fever came back again.
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| 39 | 2021-01-19 | dizziness, headache |
Caused my Fibromyalgia to flare, started have inflammation in my joints especially my ribs, headache...
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Caused my Fibromyalgia to flare, started have inflammation in my joints especially my ribs, headaches, dizziness, nausea, anxiety was also having RUQ pain which hasn?t been figured out yet. My bones and muscles and joints and tissue hurt.
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| 39 | 2021-01-19 | fatigue, headache |
Day 2 broke out in hives and headache Day 3- starting feeling extremely fatigue Day started feelin...
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Day 2 broke out in hives and headache Day 3- starting feeling extremely fatigue Day started feeling sore, legs hurt, and muscle aches Today Day 9 legs still sore and muscle aches, and fatigue Taking Benadryl at night for itching due to hives and Tylenol for soreness and muscle aches
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| 39 | 2021-01-19 | headache, fever, chills |
FEVER, CHILLS, JOINT PAIN; MUSCULAR PAIN; HEADACHE; VOMIT. TOOK ACETAMINOPHEN 500MG 2 TABS EVERY 4 H...
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FEVER, CHILLS, JOINT PAIN; MUSCULAR PAIN; HEADACHE; VOMIT. TOOK ACETAMINOPHEN 500MG 2 TABS EVERY 4 HRS
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| 39 | 2021-01-19 | fatigue, headache, headache, fatigue | Fatigue, body aches, injection site pain, headache |
| 39 | 2021-01-19 | headache, chills, fatigue, fever | Headache, fatigue, fever (102), chills, body aches, joint pain |
| 39 | 2021-01-19 | headache, fever, influenza like illness, chills, dizziness, throat irritation |
Immediately following vaccine dizziness, itching feeling in throat and skin, and nausea. A few hour...
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Immediately following vaccine dizziness, itching feeling in throat and skin, and nausea. A few hours after the vaccine, headache, nausea, dizziness continued. Face and left arm (vaccine site) felt like they were internally on fire. Twenty-four hours after the vaccine, flu-like symptoms (cold chills, fever, nausea, muscle aches to the point of it hurting to move, joint pain), headache, skin itching. Treatment was tylenol, ibuprofen, and benadryl.
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| 39 | 2021-01-19 | fatigue, fever, sweating, chills |
Lymphadenopathy to left arm pit. Fever, chills, sweats, muscle pain, and a lot of fatigue. Was unabl...
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Lymphadenopathy to left arm pit. Fever, chills, sweats, muscle pain, and a lot of fatigue. Was unable to work as had great deal of pain in arm pit it was like baseball swollen in size.
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| 39 | 2021-01-19 | headache, chills, throat pain, fatigue |
No adverse eventa occured after first vaccine. Three hours after second vaccination I started to fee...
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No adverse eventa occured after first vaccine. Three hours after second vaccination I started to feel adverse reactions. It started with sore throat, tiredness, body ache. Next morning work up with swollen lymph nodes, body ache, tiredness, headache, and the chills. Today feel alot better and adverse reactions have seem to subside.
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| 39 | 2021-01-19 | weakness |
Patient received Vaccine and during observation period began starring forward and not responding to ...
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Patient received Vaccine and during observation period began starring forward and not responding to staff. Patient was taken to the emergency room and evaluated and noted to have a flat affect and general weakness. Patient did not loos consciousness or have any signs of distress. Was admitted to the hospital and noted that she had been in out of country for a week (possibly had cosmetic surgery)
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| 39 | 2021-01-19 | sweating | Sweaty palms & fingers, "quizy stomach" nausea |
| 39 | 2021-01-19 | weakness |
Symptoms have worsened. I have an electric feeling in my legs and I am a lot weaker. I am waiting fo...
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Symptoms have worsened. I have an electric feeling in my legs and I am a lot weaker. I am waiting for an appointment with a neurologist. I also have a wheelchair that was donated.
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| 39 | 2021-01-19 | headache | Unrelenting headache for 12 days |
| 39 | 2021-01-19 | runny nose, shortness of breath, fatigue, malaise, nasal congestion |
day after 2nd injection increased fatigue, arm soreness and shortness of breath overnight requiring ...
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day after 2nd injection increased fatigue, arm soreness and shortness of breath overnight requiring rescue inhaler. Fatigue and general malaise continued x 7 days with intermittent shortness of breath requiring use of rescue inhaler. (Prior to vaccine inhaler used 3/year post vaccine requiring inhaler 2x per day). Increased post nasal drip with shortness of breath at night 02-03am each night and head congestion ear fullness during day requiring rest increased benadryl and decongestant use.
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| 39 | 2021-01-19 | headache, fever |
fever (101.4), horrible headache with use of medications to relieve, generalized body aches, sore L ...
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fever (101.4), horrible headache with use of medications to relieve, generalized body aches, sore L arm
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| 39 | 2021-01-19 | headache, fever | fever, aches, vomiting headache |
| 39 | 2021-01-19 | fever, chills, fatigue | sore arm, chills, low grade fever, body aches, fatigue |
| 39 | 2021-01-20 | headache, malaise, chills, fever, fatigue |
I received my second covid 19 vaccine on 1/18/21. I was 7 weeks pregnant at that time. About 14 ho...
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I received my second covid 19 vaccine on 1/18/21. I was 7 weeks pregnant at that time. About 14 hours after receiving the injection, I developed a fever of 100.4 accompanied by feeling unwell like I had the flu. Symptoms included local pain at the injection site, chills, malaise, headache, joint pains and fever with temp max of 102.6 at about 26 hours post vaccine. Tylenol 1000mg taken. Then I slept until the next morning. Symptoms improved by 36 hours post vaccine. Afebrile but feeling tired following throughout the next day.
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| 39 | 2021-01-20 | fatigue, headache |
Local injection site redness swelling heat and pain/local site is very painful and still red; Local ...
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Local injection site redness swelling heat and pain/local site is very painful and still red; Local injection site redness swelling heat and pain; Local injection site redness swelling heat and pain; Local injection site redness swelling heat and pain/local site is very painful; headache; extreme fatigue; diarrhea; This is a spontaneous report from a contactable Nurse (patient). A 39-year-old female patient received the second dose of BNT162b2 (Lot number: EL1284), intramuscular in left arm on 08Jan2021 15:00 at single dose for covid-19 immunization. Medical history included Hemeplegic migraines, wolff-parkinson-white syndrome (wpw), hypertension (htn), known allergies: Penicillin (PCN) and Sulfonamide (sulfa). The patient's concomitant medication was unspecified product. The patient previously received the first dose of BNT162b2 (Lot number: EH9899), at the age of 39-year-old, intramuscular in left arm on 18Dec2020 15:00 at single dose for covid-19 immunization. The patient experienced local injection site redness swelling heat and pain. Also noted was headache, extreme fatigue and diarrhea. But local site is very painful and still red day 3. The events were occurred at 12:00 on 09Jan2021. The patient did not receive the treatment for the events. The patient was not pregnant. The outcome of the events was recovering.
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| 39 | 2021-01-20 | weakness, fatigue, fever |
diarrhea; weakness; fatigue; low grade fever/my fever reached 102; body aches; This is a spontaneous...
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diarrhea; weakness; fatigue; low grade fever/my fever reached 102; body aches; This is a spontaneous report from a contactable Nurse(patient). A 39-year-old female patient received first dose BNT162B2 (lot number EJ1685) , via an unspecified route of administration at Arm Left on 20Dec2020 12:15 at the 39 years old at single dose for COVID-19 immunization. The medical history included septic shock, from 2014 multi organ failure. There were no known allergies. The concomitant medications were topiramate(TROKENDI), lisdexamfetamine mesylate(VYVANSE), bupropion, sertraline, paracetamol(TYLENOL). On 22Dec2020 12:00 the patient started to have a low grade fever and body aches. On 23Dec2020 12:00 her fever reached 102 Fahrenheit, she had body aches, diarrhea, weakness and fatigue. This continued until 27Dec2020. The patient took Tylenol and Advil for fever. Tylenol and Advil helped some with fever but not always. There was no treatment received for body aches, diarrhea and weakness and fatigue. The events low grade fever, fever reached 102, body aches, diarrhea, weakness and fatigue resulted in Emergency Room Visit. There was no other vaccine in four weeks. The patient had not COVID prior vaccination. The patient had not COVID tested post vaccination. The outcome of the events was recovered on 27Dec2020.
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| 39 | 2021-01-21 | chills, fever, fatigue | -fever of 102.8 -body aches -pain under injected arm -chills -tired |
| 39 | 2021-01-21 | body temperature increased, sweating |
Approx 9pm onset shakes, sweating , increase in temp99-100 F , chest pain , muscular pain and tight...
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Approx 9pm onset shakes, sweating , increase in temp99-100 F , chest pain , muscular pain and tightness throughout body. In middle of night started vomiting . Approx 6am called primary MD. Was instructed to go to nearest hospital.
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| 39 | 2021-01-21 | fever, headache, fatigue, chills |
CHILLS AND FEVER ON 1ST DAY AFTER VACCINE. MUSCLE ACHE, HEADACHE, NAUSEA AND TIREDNESS ON 2ND DAY. T...
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CHILLS AND FEVER ON 1ST DAY AFTER VACCINE. MUSCLE ACHE, HEADACHE, NAUSEA AND TIREDNESS ON 2ND DAY. TOOK TYLENOL AND IBUPROFEN
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| 39 | 2021-01-21 | fever, cough |
Fever, body aches , joint pain, dry cough, loss of taste of spice only. All symptoms resolved except...
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Fever, body aches , joint pain, dry cough, loss of taste of spice only. All symptoms resolved except loss of taste of spice. COVID test neg.
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| 39 | 2021-01-21 | respiratory tract congestion, headache, fatigue |
Headache/congestion nausea diarrhea body aches bone ache extreme fatigue very painful arm At inject...
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Headache/congestion nausea diarrhea body aches bone ache extreme fatigue very painful arm At injection site
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| 39 | 2021-01-21 | discomfort, fatigue |
Received the vaccine at 9:30.am on Wednesday. By noon on Thursday,felt soreness in arm. By 6pm, I f...
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Received the vaccine at 9:30.am on Wednesday. By noon on Thursday,felt soreness in arm. By 6pm, I felt a heaviness in every muscle- had to go to bed. Took Advil and had a good nights rest. Woke up the next morning, feeling better but I started feeling fatigued and achy by noon. I had to leave my job and went home and slept for 3 hours. Had dinner but had to go back to bed due to fatigue. Took Advil and Tylenol and feeling better on Friday morning.
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| 39 | 2021-01-24 | body temperature increased, discomfort |
1 week after receiving the first dose, in the afternoon i had loose stool followed by some mild abdo...
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1 week after receiving the first dose, in the afternoon i had loose stool followed by some mild abdominal cramping for the rest of the day. I took some ibuprofen. The following morning (Wednesday), the pain was on my right abdomen and right flank area only. It was persistent, achy, soreness. My insides felt very tender to put any pressure on my right abdomen or flank. The pain on the right side of my back became more intense as the day went on. I had sharp right flank pain when lifting my right leg after showering to get dressing and use lotion. When I was walking up the stairs I turned to the left and had a sharp pain in the right flank again, taking my breath away for a moment. Around 4pm I took ibuprofen. About an hour later my eyes felt hot and tired. My cheeks were pink. My temp was 99.2. I generally just didn't feel good from this achiness. I took Benadryl and went to bed at 7pm, and slept for about 12 hours, waking once at midnight. The following day (Thursday) I felt 99% better and contacted my doctors office. When putting pressure on the same areas I could feel very slight tenderness if I pushed hard. That evening and into the next morning (Friday) I was mildly achy on my right side but barely at all. I didn't feel any more discomfort until this past week on the 22nd or 23rd. During sexual intercourse I felt that same mild internal tenderness on my right side. At this time, I don't believe I have any pain. My urine seems unusually clear, light colored, and smaller volume but this is very subjective. I have some abdominal swelling but this has been present since my breast reconstruction in January of 2020 and seems to get worse or better depending on the days activities or meals so it's hard to know what causes what. Labs were done on 1/22 showing decreased kidney fuction. Pending tests include an ultrasound of the Right Ovary that remains after the hysterectomy, bladder, and kidney. In addition to a 24 hour urine and some other urine studies.
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| 39 | 2021-01-24 | headache, fever, fatigue, dizziness |
Recieved the 2nd dose of Covid on 1/21/2021 at 8am the symptoms started that night around 9pm. Fat...
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Recieved the 2nd dose of Covid on 1/21/2021 at 8am the symptoms started that night around 9pm. Fatigue, achy, and nausea. Wake up at 11pm with fever 104.8, ears pounding, dizziness, swollen elbow and hand pain on same arm of injection. Fever over the next 24hrs went to 105.9. Nausea and extreme jaw pain and joint pain. fever resolved after 26hrs. Still having dizziness, arm around injection site is warm to touch, swollen, and joint painful. headache and neck pain still. treating with motrin and tylenol that was started 26hrs after the injection.
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| 39 | 2021-01-24 | chills, fever, fatigue |
chills, fever (highest 102.8), body aches onset around 1am (approx 16 hrs after receiving dose); wok...
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chills, fever (highest 102.8), body aches onset around 1am (approx 16 hrs after receiving dose); woke up around 5am and fever had come down; by the time I awoke again at 11am I felt very tired but all other symptoms had resolved
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| 39 | 2021-01-25 | fever, headache |
12 hours after the second dose I experienced body aches, low grade fever for about 6 hours. After t...
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12 hours after the second dose I experienced body aches, low grade fever for about 6 hours. After that I had upper and lower back pain, neck pain and a mild headache.; 12 hours after the second dose I experienced body aches, low grade fever for about 6 hours. After that I had upper and lower back pain, neck pain and a mild headache.; 12 hours after the second dose I experienced body aches, low grade fever for about 6 hours. After that I had upper and lower back pain, neck pain and a mild headache.; 12 hours after the second dose I experienced body aches, low grade fever for about 6 hours. After that I had upper and lower back pain, neck pain and a mild headache.; 12 hours after the second dose I experienced body aches, low grade fever for about 6 hours. After that I had upper and lower back pain, neck pain and a mild headache.; breastfeeding; breastfeeding; This is a spontaneous report from a contactable other healthcare professional (HCP). The reporter reported for herself and her child. This is the mother report. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231), via an unspecified route of administration on 08Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included breast feeding from an unknown date and unknown if ongoing. The patient previously took BNT162B2 on 18Dec2020. The patient stated on 08Jan2021, 12 hours after the second dose, she experienced body aches, low grade fever for about 6 hours. After that she had upper and lower back pain, neck pain and a mild headache. She took Advil and felt normal shortly after for the rest of the day and there after. She would categorize my symptoms as mild. The outcome of the events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021030867 Parent/fetus cases.
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| 39 | 2021-01-25 | fatigue, dizziness |
1:08 Injection; 30 min wait time , 1:40 Tingly lower lip and dizzy 1:45 Benadryl 50mg; bp 122/7...
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1:08 Injection; 30 min wait time , 1:40 Tingly lower lip and dizzy 1:45 Benadryl 50mg; bp 122/72 HR 83, pox 99 2pm still dizzy ", somewhat ; somewhat less tingly lip" couldn't give a scale 2:20 per DNS Deb, improved slightly. 2:30 very tired - may be contributed to 50mg Benadryl. 2:30 medical director examined. She feels okay, sent home with another staff member. Suggest contact her dr tomorrow and before next vaccine. Suggest do it at a medical facility.
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| 39 | 2021-01-25 | throat irritation |
First vaccine on 12/30/20 almost immediately after receiving vaccine metallic taste in mouth, follow...
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First vaccine on 12/30/20 almost immediately after receiving vaccine metallic taste in mouth, followed by itchy throat and felt throat slightly thighten took Benadryl and received relief Second dose on 1/20/21 took a Zyrtec per doctor?s instruction prior to receiving vaccine about 15 minutes after receiving second dose tongue numbness and weird taste in mouth now and developed itchy face, managed with Zyrtec although itchiness not resolved, taking Zyrtec every day since second dose, yesterday 1/25 in afternoon still medicated under Zyrtec face began to swell on left side of face, persistent itchy face, itchiness went down to other areas including neck, chest, bumps on left hand now on an oral steroid per my doctor
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| 39 | 2021-01-25 | fatigue |
General fatigue day of injection which resolved by morning. On day 6 after vaccination I developed a...
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General fatigue day of injection which resolved by morning. On day 6 after vaccination I developed a large well demarcated rash with warmth and swelling around the injection site. This has now mostly resolved this morning.
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| 39 | 2021-01-25 | cough |
Patient was given vaccine #2 and approximately 15 minutes post vaccination she developed a cough. Sh...
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Patient was given vaccine #2 and approximately 15 minutes post vaccination she developed a cough. She used two puffs on her inhaler and then she started to feel tightness in her throat. She was then given 25 mg of liquid Benadryl. She then developed trouble swallowing and was given 0.3 mg of sub-q epinephrine. Patient did not develop any respiratory distress and vital signs remained stable. She was transferred to the Emergency Department.
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| 39 | 2021-01-25 | fever, chills |
SYMPTOMS LASTING 2 DAYS: MILD SKIN & MUSCLE SORENESS @ INJECTION SITE.. SEVERE CHILLS AND BODY ACHES...
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SYMPTOMS LASTING 2 DAYS: MILD SKIN & MUSCLE SORENESS @ INJECTION SITE.. SEVERE CHILLS AND BODY ACHES. FEVER FLUCTUATING BETWEEN 99.4 AND 101.2. TOOK IBUPROFEN EVERY 4 HRS AS NEEDED TO REDUCE FEVER.
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| 39 | 2021-01-25 | cough, respiratory tract congestion, fatigue |
Sore arm; a little tired; second dose was due 25Jan2021; Tested positive for COVID-19 on 03Jan2021/c...
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Sore arm; a little tired; second dose was due 25Jan2021; Tested positive for COVID-19 on 03Jan2021/congestion and cough; Tested positive for COVID-19 on 03Jan2021/congestion and cough; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). This 39-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via intramuscular at left deltoid on 28Dec2020 11am at single dose for COVID-19 immunization. Medical history included non-smoker with no other illness. Concomitant medication was none. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Patient reported after receiving her first dose of the COVID-19 vaccine on 28Dec2020, she had sore arm and a little tired, other than that felt fine. She stated second dose was due 25Jan2021. She was tested positive for COVID-19 (Rapid Covid testing) on 03Jan2021. She already decided going to wait the 90-day-period to get the second dose of the vaccine. Since she was quarantined she wanted to what she should do. She stated her having testing positive for Covid did not have anything to do with the vaccine. She still had some lingering symptoms, congestion and cough. Nothing had worsened, but just wouldn't go away. She did not receive any other vaccines the same day or 4 weeks prior. No history of problems with vaccines in past. She had not had antibodies checked yet. It was reported no AE required a visit to emergency room/physician office. The patient was not hospitalized. The patient received no additional therapies for COVID-19. Patient's outcome with COVID-19 was recovering, and the rest of events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tested positive for COVID-19 (Rapid Covid testing), which is considered ineffective of BNT162B2, and the administration of BNT162B2.
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| 39 | 2021-01-25 | throat swelling |
Swollen Throat; This is a spontaneous report from a contactable consumer. A 39-year-old female patie...
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Swollen Throat; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received the first dose of BNT162B2 (lot number unknown), via an unspecified route of administration in left arm, on 12Jan2021 04:15 PM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient's medical history included Pennicilin allergies. Concomitant medication was none. No other vaccines were received within 4 weeks prior to the COVID vaccine. No medication received within 2 weeks of vaccination. The patient experienced swollen throat on an unknown date. No treatment was received for the event. The outcome of the event was recovered. Information on the lot/batch number has been requested.
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| 39 | 2021-01-25 | fever, headache |
Woke up with a low fever, body aches, left arm pain and a little headache after taking the 2nd Covid...
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Woke up with a low fever, body aches, left arm pain and a little headache after taking the 2nd Covid vaccine dose. I took Tylenol and my fever and body aches went away. Still got a minor headache and left arm pain.
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| 39 | 2021-01-25 | chills, fever |
chills; muscle ache; low grade fever up to 100.3; a red flushed rash on neck and chest; This is a sp...
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chills; muscle ache; low grade fever up to 100.3; a red flushed rash on neck and chest; This is a spontaneous report from a contactable nurse (patient). A 39-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 09Jan2021 12:00 at single dose in left arm for covid-19 immunization. The patient had no other medical history and no known allergies. Concomitant medication included vitamin D3 and daily multivitamin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), on 20Dec2020 07:30 in left arm for covid-19 immunization. The patient had no covid prior vaccination and no covid tested post vaccination. The patient reported that on 10Jan2021 02:00 about 14 hours after 2nd vaccine she had chills, muscle aches, and low grade fever up to 100.3 for the next 12 hours. Then she experienced a red flushed rash on neck and chest for about 12 hours after the previous symptoms. All symptoms gone after about 24 hours. The patient did not receive any treatments for events. The outcome of the events was recovered on 11Jan2021.
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| 39 | 2021-01-25 | fever, chills |
fever; Chills; a very big Lymph Node on my left arm armpit; This is a spontaneous report from a cont...
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fever; Chills; a very big Lymph Node on my left arm armpit; This is a spontaneous report from a contactable other hcp (patient). A 39-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported), via an unspecified route of administration on the left arm on 10Jan2021 10:43 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included gabapentin. The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899, expiry date not reported) on the left arm on 24Dec2020 for COVID-19 immunization. The patient experienced fever, chills, and a very big lymph node on their left arm armpit on 11Jan2021 21:00. The outcome of the events was unknown.
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| 39 | 2021-01-26 | fever, fatigue, headache |
Body aches; Exhaustion/fatigue; Low grade fever; Headache; Foggy; This is a spontaneous report from ...
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Body aches; Exhaustion/fatigue; Low grade fever; Headache; Foggy; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 39-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0142) intramuscular in Left arm on 12Jan2021 08:30 at single dose for COVID-19 immunisation. She received the first dose (lot number=EJ1685) intramuscular in left arm on 22Dec2020 08:30 AM at age of 38 years old for COVID-19 immunisation. The patient medical history was not reported. There was no known allergies. Concomitant medication included phentermine. On 12Jan2021 21:30, the patient experienced body aches, exhaustion/fatigue, low grade fever, headache, foggy. No treatment received for events. The patient was not pregnant. Events outcome was recovering.
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| 39 | 2021-01-26 | chills, headache, nasal congestion | Employee suffering from headache, congestion, chills & muscle ache. |
| 39 | 2021-01-26 | night sweats, fatigue, fever | I had a fever, fatigue, achy , night sweats. |
| 39 | 2021-01-26 | chills, headache |
I woke up around 2am with chills, an intense headache and body aches. I have pain at my injection si...
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I woke up around 2am with chills, an intense headache and body aches. I have pain at my injection site.
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| 39 | 2021-01-26 | fever, migraine, malaise, discomfort |
L Axillary lymphadenopathy; Fever 102.8 (H); muscle aches/heaviness; Migraine; Tachycardia; Chest pr...
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L Axillary lymphadenopathy; Fever 102.8 (H); muscle aches/heaviness; Migraine; Tachycardia; Chest pressure/pain; Chest pressure/pain; elevated BP; malaise; This is a spontaneous report from a contactable 39-year-old female Nurse reported for herself. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number E10140), intramuscular in arm left on 11Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included Low BP, depression, insomnia, latex allergy. The patient was allergy to morphine and diltiazem (CARDIZEM). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, E10140) on 24Dec2020 10:45 AM, intramuscular in left arm at age of 39 years old for Covid-19 immunization. Concomitant medication included cefixime (FLEXERIL), diphenhydramine hydrochloride (UNISOM), acetylsalicylic acid (ASPIRIN) and ibuprofen. The patient experienced l axillary lymphadenopathy, fever 102.8, muscle aches/heaviness, migraine, tachycardia, chest pressure/pain, elevated bp, malaise, all on 11Jan2021 23:00 with outcome of recovered with sequelae. The patient underwent lab tests and procedures which included blood pressure: elevated on 11Jan2021, body temperature: 102.8 on 11Jan2021 (H), nasal swab: negative on 12Jan2021 (Covid test post vaccination). The events were non-serious, result in emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient received Bolus of IV (intravenous) fluids for treatment.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 39 | 2021-01-26 | influenza like illness, malaise, headache, fatigue |
Patient rec'd Pfizer #1 on 1/22/21 (L deltoid) @ 3:30 p.m. 1/22 @ 4 p.m. - Hives & itching started ...
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Patient rec'd Pfizer #1 on 1/22/21 (L deltoid) @ 3:30 p.m. 1/22 @ 4 p.m. - Hives & itching started after obs, "feeling unwell" so patient returned to obs for additional 15 min. Cleared to RTW. After eating, @6 p.m. patient noted difficulty swallowing in evening & change in voice so she thought she had throat swelling. Took Benadryl 25 mg PO and Tylenol rapid release for HA. Hives resolved that evening and patient went to sleep. Over the weekend, had flu like symptoms, nausea, fatigue, HA. Took Benadryl 12.5 mg PO on 1/23 and continued Tylenol through weekend. 1/26 - 1/27: Signs and symptoms resolved
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| 39 | 2021-01-26 | nerve pain, chills, fatigue, headache |
Severe neuralgia pain over 75% of her skin surface; Severe neuralgia pain over 75% of her skin surfa...
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Severe neuralgia pain over 75% of her skin surface; Severe neuralgia pain over 75% of her skin surface; Severe joint pain; Muscle aches; Swollen lymph nodes; Headache; Fatigue; Upper body sporadic shivering; Interval between the first and second doses of BNT162B2 is 27 days; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246), via an unspecified route of administration in right arm, on 14Jan2021 at 17:15, at a single dose, for COVID-19 immunization. The patient's medical history included sporadic neuralgia, numbness to patches on legs, shift-work sleep disorder, and generalized anxiety. The patient's concomitant medications included armodafinil (NUVIGIL), paracetamol (TYLENOL), and alprazolam (XANAX). The patient previously took ferric subsulfate (MONSELS Solution) and experienced allergy; and the first dose of BNT162B2 (Lot Number: EH9899) on 18Dec2020 (6 PM) for COVID-19 immunization (in left arm). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 14Jan2021 (05:15 PM), the interval between the first and second doses of BNT162B2 is 27 days. On 15Jan2021 at 9:15 AM, the patient experienced severe neuralgia pain over 75% of her skin surface beginning at 14 hours post-second dose (as reported) and still continuing now at 30 hours post-dose. Also, the patient experienced severe joint pain, muscle aches, swollen lymph nodes, headache, fatigue, and upper body sporadic shivering (not cold). It was unknown if the patient received treatment for the events. The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
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| 39 | 2021-01-26 | shortness of breath, sweating |
Systemic: Patient got really sweaty about an hour after the vaccine. Blood pressure was elivated an...
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Systemic: Patient got really sweaty about an hour after the vaccine. Blood pressure was elivated and patient reported mild SOB.-Medium
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| 39 | 2021-01-26 | chills, weakness, fever, malaise, headache |
The next morning after my vaccine I went into work feeling a little achy and a slight headache then ...
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The next morning after my vaccine I went into work feeling a little achy and a slight headache then by 8:00am I felt like a train hit me, my body was chilling, shaking despite being in front of a heater, I had a low grade fever, my right side of my head hurt so incredibly bad like my right eye was going to explode, I then started vomiting. My boss came to help walk me outside because I didn?t even feel like it was me walking. I don?t remember walking out of work. I was there but ?not there?. I was not myself. I didn?t feel like i was in my body. I had to have my husband come get me from work, I slept most the rest of the day and night. Now I?m on day 2 and my joints still ache, my head hurts so bad, I am so tired I either am asleep on the couch or in bed. I have no energy. It takes everything I have to move just to go to the bathroom.
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| 39 | 2021-01-26 | headache |
diarrhea at 3pm same day of vaccine till Saturday night. Friday night Pain to arm/injection site ar...
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diarrhea at 3pm same day of vaccine till Saturday night. Friday night Pain to arm/injection site around 10pm. Took Tylenol. Had slight pain to forehead around 8pm started to bruise. Saturday woke up with slight pain to arm/left side of neck. Bruise larger today. Saturday evening swollen. Lots of pain and trouble turn head. Left side neck/shoulder area pain. Applied ice/took Advil. At times hard to move arm, neck. bone pain by injection site. Now had pain from elbow to neck area, and shoulder on left arm for about 5 days now. At times pain feels like my bones hurt in those areas. Still swollen with bruising. Using pain meds ever 4 hours. And placing hot/cold packs with little relief.
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| 39 | 2021-01-26 | fatigue, headache |
frontal and occipital headaches; hot flashes; exhaustion; This is a spontaneous report from a contac...
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frontal and occipital headaches; hot flashes; exhaustion; This is a spontaneous report from a contactable Nurse (patient). A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EH9899), on 11Jan2021 07:45 at SINGLE DOSE in Left arm for COVID-19 immunisation. Facility type vaccine was Hospital. Medical history included irritable bowel syndrome (IBS) , anxiety and depression. No other vaccine in four weeks. Concomitant medication in two weeks included buspirone, escitalopram. The patient previously received first dose of BNT162B2 (lot number=EH9899), on 21Dec2020 10:00 AM, at SINGLE DOSE in Left arm for COVID-19 immunisation. The patient experienced Continued frontal and occipital headaches on day 2 with no relief from Tylenol, hot flashes, and exhaustion, all on 12Jan2021 02:00 AM. The outcome was Not recovered. No treatment for hot flashes, and exhaustion. No COVID prior vaccination. Covid test post vaccination included Nasal Swab on 12Jan2021 with result of Negative.
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| 39 | 2021-01-27 | headache, throat irritation |
39 yo female was noted ~40 minutes after vaccine to appear flushed. Her face, neck and upper arms we...
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39 yo female was noted ~40 minutes after vaccine to appear flushed. Her face, neck and upper arms were red. Upon questioning she reported she felt hot and itchy. Upon request she removed her jacket. Vital signs normal. She self-administered 25 mg of Benadryl. About 10 minutes later she reported developing a headache but otherwise reported some improvement in feeling hot and her facial/arm redness improved. She was originally given discharge instructions including home precautions and released to self, however a few minutes after leaving the patient walked back into the vaccination site and reported itching in throat with clearing throat. Patient was administered epinephrine 0.3mg IM and transferred to ER via EMS.
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| 39 | 2021-01-27 | headache |
Numbness around my mouth and my jaws wants to lock up like headache; Numbness around my mouth and my...
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Numbness around my mouth and my jaws wants to lock up like headache; Numbness around my mouth and my jaws wants to lock up like headache; Numbness around my mouth and my jaws wants to lock up like headache; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK4176), via an unspecified route of administration on 08Jan2021 at a single dose for covid-19 immunisation. Medical history included anxiety and some depression. Concomitant medication included sertraline hydrochloride (ZOLOFT) for anxiety and some depression, clonazepam for anxiety when it gets extreme. On an unspecified date in Jan2021, the patient experienced numbness around her mouth and her jaws wants to lock up like headache. The patient received ibuprofen, Tylenol and Advil as treatment for the event. The patient is due to receive second dose on 29Jan2021. The outcome of the events was unknown.
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| 39 | 2021-01-28 | headache, shortness of breath |
10 hrs after I received 1st dose of Pfizer I started feeling my heart beating rapidly and hard. I w...
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10 hrs after I received 1st dose of Pfizer I started feeling my heart beating rapidly and hard. I was short of breath and had nausea and a headache. This lasted for 1.5 hrs. then I laid down. As I was falling asleep I couldn't shake a scary "vision: I was having of myself like my eyes turning bright blue and electricity going through my body and my body ascending into the air. I had nightmares all night. I have never had hallucinations or whatever that was. And nightmares are rare for me. I woke up fine on day 2, just a stiff sore arm. Day 3 I was fine. Day 4 I am developing an itchy, bumpy, rash on my right arm at site of injection and around it. I reported this online on my health chart and will go in if I keep getting strange reactions.
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| 39 | 2021-01-28 | chills, fever, shortness of breath |
Fever, chills and shortness of breath occurred approximately 23 hours after administration. Went to ...
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Fever, chills and shortness of breath occurred approximately 23 hours after administration. Went to ED and was released to home.
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| 39 | 2021-01-28 | dizziness |
Had COVID December 19, 2020. Had 1st dose Pfizer on 1/6 and 3 hrs after had heart palpitations, dizz...
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Had COVID December 19, 2020. Had 1st dose Pfizer on 1/6 and 3 hrs after had heart palpitations, dizzy, HR 110-115. Lasted for 48 hours intermittently. 1/29 15 minutes after 2nd dose was dizzy. @ 1120 B/P 110/79 sats 100%, HR 67, @1126 B/P 107/80, HR 72. Stayed for 40 minutes and left feeling fine. Takes no meds, In 2002 had GI Ulcers and was treated and Allergic to Proton Pump Inhibitors- hives, heart palpitations, generalized swelling, dyspnea
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| 39 | 2021-01-28 | dizziness, throat swelling |
Patient complained of right sided throat swelling that started 15 minutes after receiving vaccinatio...
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Patient complained of right sided throat swelling that started 15 minutes after receiving vaccination. She also reported dizziness and nausea. She denies rash, hives, shortness of breath, tongue swelling, lip swelling, and any other symptoms. Patient received 50mg of Benadryl and 50mg of Solu Medrol upon arrival to ED which improved her symptoms.
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| 39 | 2021-01-28 | fatigue |
Tiredness; painful swollen lymph nodes/lymph nodes on base of her neck started to become swollen and...
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Tiredness; painful swollen lymph nodes/lymph nodes on base of her neck started to become swollen and tender; injection site soreness; painful swollen lymph nodes/Lymph nodes on base of my neck started to become swollen and tender; kind of a side effect it was worst; my right deltoid is really very sore and my neck has really become sore.; my right deltoid is really very sore and my neck has really become sore.; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Brand=Pfizer; lot number: EL3248) via an unspecified route of administration at right arm on 13Jan2021 at 09:15 AM at a single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. No other vaccine in four weeks. Other medications in two weeks included hydrochlorothiazide/losartan potassium (LOSARTAN/HYDROCHLOROTHIAZIDE), pantoprazole sodium sesquihydrate (PROTONIX), multivitamins/plain (reported as MVI), biotin, docusate sodium (COLACE), Adde (to be clarified). The patient was not pregnant. Facility type vaccine was at Hospital. No COVID prior vaccination. No COVID tested post vaccination. The patient experienced adverse events included tiredness, painful swollen lymph nodes, injection site soreness; all with start date on 13Jan2021 and with outcome of not resolved. No treatment received for events. It was also reported right deltoid had been sore, lymph nodes on base of her neck started to become swollen and tender; kind of a side effect it was worst, and neck had really become sore; all on 13Jan2021 and with outcome of unknown. The patient stated she had the vaccine on 13th and her right deltoid had been sore. Yesterday (15Jan2021) her lymph nodes on base of my neck started to become swollen and tender, she knew it's a kind of a side effect but it was worst today than it was yesterday and she just wanted to know how long those side effect last because her right deltoid was really very sore and her neck had really become sore.
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| 39 | 2021-01-28 | headache, chills, fatigue |
fatigue; Pain at injection site; chills; body aches; headache; neck pain; joint pain; nausea; This i...
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fatigue; Pain at injection site; chills; body aches; headache; neck pain; joint pain; nausea; This is a spontaneous report from a non-contactable nurse (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 13Jan2021 09:45 at single dose in left arm for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient had no covid prior vaccination and no covid tested post vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248), via an unspecified route of administration on 23Dec2020 14:45 at single dose in left arm for COVID-19 immunization. The patient experienced pain at injection site, chills, body aches, headache, neck pain, joint pain, nausea, fatigue on 14Jan2021 02:00. The outcome of the events was recovered in Jan2021. The patient did not receive treatment for the events. No follow-up attempts are possible. No further information is expected.
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| 39 | 2021-01-31 | dehydration |
Pfizer-BioNTech COVID- 19 Vaccine Patient experienced nausea and palpitation approximately 2 hours ...
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Pfizer-BioNTech COVID- 19 Vaccine Patient experienced nausea and palpitation approximately 2 hours post COVID-19 vaccine dose #2. Presented to emergency department and found to have new onset atrial fibrillation with rapid ventricular rate (pulse 155), and dehydration. Patient treated with metoprolol 5 mg IV and aspirin 325 mg orally, and subsequently converted to normal sinus rhythm. Patient admitted for observation and discharged with resolution of symptoms on 1/29/2021.
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| 39 | 2021-02-01 | fever | Reported feeling achy and fever of 101.2F. |
| 39 | 2021-02-03 | fatigue, malaise, fever, chills, headache | Headache Fever, chills, malaise, fatigue Narrative: |
| 39 | 2021-02-03 | discomfort |
I have a lot of muscle pain in my left arm and my shoulder blade, I can't sleep very well because of...
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I have a lot of muscle pain in my left arm and my shoulder blade, I can't sleep very well because of the pain, I have taken ibuprofen few times but it calms me down for a few hours, yes I can lift my arm and move it but I feel pain and discomfort all the time.
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| 39 | 2021-02-04 | weakness, fatigue, sweating, chills, fever |
severe fatigue; chills/rigors; fever; myalgia; global weakness; sweating; nausea; This is a spontane...
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severe fatigue; chills/rigors; fever; myalgia; global weakness; sweating; nausea; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 06:45 at single dose (vaccine location=right arm) for covid-19 immunisation. The patient medical history was not reported. No known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received first dose of BNT162B2 on unspecified date at single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. The patient experienced severe fatigue, chills, fever, rigors, myalgia, global weakness, sweating and nausea on 21Jan2021 07:00 PM. It was unknown if treatment received for events. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 39 | 2021-02-07 | throat irritation |
Patient is a 39 y.o. female presenting to ED with itchy tongue and throat which occurred 1 hour afte...
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Patient is a 39 y.o. female presenting to ED with itchy tongue and throat which occurred 1 hour after second dose of COVID-19 patient received vaccination this morning. Patient states symptoms started an hour and a half after vaccine administration. Patient denies rash or swelling. Patient received 50 mg of Benadryl for presentation. Patient will be discharged and instructed to follow up with primary care doctor in 1-2 days and return to the ED if symptoms worsen. Symptoms believed to be from allergic reaction, nausea. Pt received atarax, pepcid, zofran, decadron.. Patient will be discharged with atarax, epipen. Pt has no oral swelling on repeat exam.. Patient understands and agrees with plan.
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| 39 | 2021-02-07 | fever, dizziness |
cellulitis in arm; Dizzy head; sore; a few lymph nodes reacted; This is a spontaneous report from a ...
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cellulitis in arm; Dizzy head; sore; a few lymph nodes reacted; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if patient was pregnant. The patient received the first dose of BNT162B2 (lot number: EL0140) on 28Dec2020 for covid-19 immunization. On an unknown date in Jan2021, the patient experienced Dizzy head and sore. Then injection site swelling and was hot to the touch and a few lymph nodes reacted. Two days of 102+ fever, diagnosis of cellulitis in arm. Antibiotics received for cellulitis. Adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 39 | 2021-02-08 | headache |
Patient is a 39-year-old white female with a PMH of depression, anxiety, migraine and chronic sinusi...
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Patient is a 39-year-old white female with a PMH of depression, anxiety, migraine and chronic sinusitis. She has NKDA. Her medications prior to event included alprazolam 0.25mg Qday, citalopram 20mg, 1 and ½ tabs Qday, Topamax 25mg, 3 tabs Qday and Zyrtec 10mg Qday. She was administered her first dose of the Pfizer COVID vaccine on 1/21/21 at 1:30pm. She presented to the hospital on 1/22/21 @ 9:45am with acute onset of right sided weakness (she is a teacher who collapsed in her classroom without LOC) and was found to have a intraparenchymal hematoma (IPH) in the left posterior paramedian frontal lobe measuring up to 2.9 x 1.8 x 3.4cm with surrounding vasogenic edema and mild local mass effect with no underlying mass lesion or vascular malformation on MRI. She stated that she has had intermittent headaches over the last few weeks not similar to her prior migraines, although with no neuro deficits. She was also noted to have a urine tox screen positive for amphetamines. There is a confirmatory test pending. She was discharged to acute rehab on 1/25/21. Patient is still recovering from the adverse event. She did not receive any other vaccines within a month prior to the event.
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| 39 | 2021-02-09 | throat pain, skin warm, fever, weakness |
Began with fever, tonsillitis, sore throat, sinus drainage, muscle aches. Then on Saturday night the...
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Began with fever, tonsillitis, sore throat, sinus drainage, muscle aches. Then on Saturday night the body aches were progressively worse and concentrated on left side of body. Joints were affected including left wlbow, wrist, shoulder. Hot viral rash appeared on arm right above left elbow that became painful with swelling and erythema. In Sunday through the following Wednesday, joint pain continued to worsen and settle in additional joints including first 2 metacarpal bones of both hands almost like arthritic pain. Fingers and joints red and swollen. Pain and swelling next settled in toes of both feet, right side elbow, shoulder and knee. On Monday following vaccine I called employee health and they advised me to come and take covid test. I described symptoms and was told they were side effects of the vaccine and to follow up with a doctor if it continues. My covid test was negative. On the following Thursday I went to urgent care and described my persisting symptoms. I was prescribed a methylprednisolone pack and hydroxyzine. I was told to use naproxen as needed. Yesterday the urgent care sent a check up message. I am still experiencing joint pain although the intensity has decreased but it is still significant pain that is disabling my grip and strengrh overall. The joint pain is mostly just in my upper extremities, hands, fingers and shoulders now consistently. The np prescribed a 10 day pack of meloxicam to try and help minimize the pain.
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| 39 | 2021-02-11 | shortness of breath, headache |
I got a strange vision/hallucination; rapid and hard heartbeat; shortness of breath; nausea; headach...
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I got a strange vision/hallucination; rapid and hard heartbeat; shortness of breath; nausea; headache; had nightmares all night; stiff, sore arm; stiff, sore arm; my arm has a bumpy, red mild rash at and around injection site; my arm has a bumpy, red mild rash at and around injection site; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), via an unspecified route of administration on 26Jan2021 at 14:45 (at the age of 39 years) as a single dose in the right arm for COVID-19 vaccination. Medical history included fatty liver. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications were not reported. The patient reported that on 27Jan2021 at 12:30 AM, approximately ten hours after the vaccine, the patient experienced a rapid and hard heartbeat, shortness of breath, nausea and headache. These lasted for one and one half hours. As she lay down falling asleep she got a strange vision/hallucination (this had never happened to her before) of her eyes turning lightning blue and her body rising up in the bed. She stated that she does not take medications or drugs and does not have a history of mental illness. She could not shake the vision. She fell asleep and had nightmares all night and nightmares are rare for her. One day two she woke up fine just a stiff, sore arm. On day three her arm has a bumpy, red mild rash at and around injection site. The patient did not receive any treatment for the events. Lab data included a COVID SARS CoV-2 positive test on an unspecified date. The clinical outcomes of hallucination, heart rate increased, shortness of breath, nausea, headache, nightmares, pain in arm, limb stiffness and vaccination site rash were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 39 | 2021-02-11 | chills, fever, fatigue |
cold extremities; fever; chills; fatigue; rheumatoid arthritis; This is a spontaneous report from a ...
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cold extremities; fever; chills; fatigue; rheumatoid arthritis; This is a spontaneous report from a non-contactable physician. A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. Historical Vaccine included received first dose of BNT162B2 intramuscular at the age of 39-year-old on 16Dec2020 at single dose for COVID-19 immunization and did fine. The patient did fine after first dose, after second dose had 36 hours of fever and chills. Covid test negative. Several weeks later she developed fatigue and cold extremities. She was found to have elevated CCP (Cyclic Citrullinated Peptide) antibodies, dx (diagnosis) rheumatoid arthritis. All events occurred on 04Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment received for the events included medication for pain, specialist referral. There was no other vaccine received in four weeks. The patient was no pregnant. The patient had no COVID prior vaccination. Covid test (Nasal Swab) post vaccination was Negative. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the time association and drug's safety profile, the events fever, chills, fatigue, and cold extremities are possibly related to suspect vaccine BNT162B2 administration. The event rheumatoid arthritis is more likely underlying/intercurrent condition, unrelated to suspect vaccine BNT162B2 injection given the product's safety profile and the pathophysiology of rheumatoid arthritis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 39 | 2021-02-15 | fever, weakness |
1/21/21 pt started experiencing fever about 3:30 PM, went to Urgent care received rapid COVID test w...
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1/21/21 pt started experiencing fever about 3:30 PM, went to Urgent care received rapid COVID test which was negative, 1/22/21 still has fever drive thru at hospital covid drive thru pt had PCR and it was also negative, went back to same drive thru on 1/24/21 and had another PCR which was negative, 1/25/21 urgent care visit, pt was tested for flu-Negative, lab work was done which showed CBC all counts were low resulted in ER visit, admitted 1/25/21 afternoon with panside apnea and sepsis and patient stayed in hospital for 9 days 2/2/21 pt was released to go home. Lots of labs and test were done while patient was inpatient, Pt is still weak and has no energy.
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| 39 | 2021-02-16 | shortness of breath, throat irritation |
Anaphylaxis: After my second dose of the vaccine within 3-5 minutes I stared feeling swelling of th...
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Anaphylaxis: After my second dose of the vaccine within 3-5 minutes I stared feeling swelling of the thong, itchy throat, head, neck, sob. I immediately reported my symptoms to the MD that was in the room monitoring the recent vaccinated employees. Immediately he administered 50mg of Benadryl, 20mg of Pepcid, and salbutamol. I was rushed to the ED and stayed there for couple of hours headed back to my unit and then sent home by my manager.
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| 39 | 2021-02-17 | shortness of breath, headache |
01/09/21, 25 minutes after I got my 2nd dose, I felt heart palpitation. I my heart rate was 109 at s...
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01/09/21, 25 minutes after I got my 2nd dose, I felt heart palpitation. I my heart rate was 109 at sitting. I feel my heart beats stronger than normal. my heart palpitation didn't improve overnight. 01/10/21 I feel shortness of breath with talking and walking. My chest hurts. My head hurst. I call my hospital and talked to an RN urgent line. She suggested me to go to Urgent Care or ER. I went to Urgent Care at 1500 that day. At check in my blood pressure was 160/110 (my normal BP is around 120/90 or less) heart rate was 112. EKG was done, result no concern. Urgent Care Doctor sent me home with no medication. He said what I experienced is the reaction of my body with the Covid vaccine. He told me to go to ER if my symptoms get worse. I went and see my primary doctor ( bloods tests was done ) and Cardiologist after with EKG and ECHO done. I was off from work during that time. I feel back to normal after 10 days.
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| 39 | 2021-02-17 | chills | Throat tight, hard to swallow, extreme dry mouth, chills, shaking, anxiety |
| 39 | 2021-02-18 | sweating, chills |
The patient was admitted to the hospital on February 10, 2021 for evaluation of jaundice. This is a...
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The patient was admitted to the hospital on February 10, 2021 for evaluation of jaundice. This is a healthcare worker (direct patient care) and she received the first dose of Covid 19 vaccine in January 13 2021, then subsequently developed some abnormalities of the liver enzymes and thrombocytopenia. Because of this, her second vaccine was held. She also subsequently noticed scleral jaundice. She reports that it was 5 days since the COVID-19 vaccine on January 13 when she developed a rash which was present in the legs anterior abdomen and arms. Then 8 days after the vaccine, she developed a different rash on top of the original which was less petechial and more maculopapular. The rash is pruriginous, its been intermittently worsening and improving. She had no fever associated with the rash, although she reports that the day before admission February 9, she had some chills and sweats. She had some mild abdominal pain and cramps. No prior history of hepatitis. She also developed a petechial rash predominantly in the lower extremities. Results of ancillary studies showed that her AST is currently (02/12/21) 196 ALT of 61, her bilirubin total was 7.9 with a direct of 5.5, and on admission her AST was 183 ALT 40, with a total bilirubin of 14. Her platelet count on admission was 111, currently is 93. She has some mild microcytic anemia and no leukopenia and in the differential she has increased monocytosis. Her viral hepatitis serology panel shows hepatitis a IgM that is negative hepatitis B surface antigen and core antibody negative, hepatitis B surface antibody positive consistent with previous vaccination, and hepatitis C antibody negative. COVID-19 antigen was negative on admission 2/10/2021 she reports that she had a Covid PCR done in her office 5 days or so before admission that was also negative. She has been seen by our GI who evaluated her liver abnormalities. Imaging studies including a CT scan of 2/10/2021 showed chronic changes in the colon that could be consistent with inflammatory process such as ulcerative colitis, and a diffuse heterogeneous enhancement of the liver with nodularity that could be consistent with cirrhosis. She has a splenic varices and gastric varices which would make the diagnosis of cirrhosis certainly possible. An MRI of her abdomen on 2/11/2021 shows confirmation of the cirrhotic changes in the liver biliary dilatation or gallbladder abnormalities. There is evidence of portal hypertension. He also had a liver ultrasound that shows findings consistent with possible cirrhosis, including splenomegaly, hepatomegaly, and GB sludge. Alpha 1 antitrypsin, LKM antimitochondrial and anti-smooth muscle antibodies are negative. ANA and ANCA are pending. CMV and EBV PCR are pending. Given the unclear underlying etiology of her liver abnormalities, she had a liver biopsy. Result-Suggestive of NASH and confirms F4 cirrhosis. The patient was a started on Cipro and Flagyl empirically because of the findings on the colon suggestive of possible cholangitis. She has normal renal function. She has had no tick bites, no exposure to animals, no external factors consistent with atopic dermatitis or allergic type of rash. She reports that before admission, she had normal platelets about 1 or 2 years ago when she was tested, as well as normal liver function test. She reports that she has had some mild epistaxis as well as bleeding from her lips. She has some anorexia, she has had some looser stools but has been clear without obvious blood and she has had no hematuria. EGD on 15FEB2021- mild portal hypertensive gastropathy. Low risk esophageal varices. Labwork 15FEB2021- AST 173/ALT 64/Alk Phos 235/Plt 109/ Discharged on 02/15/2021 to home with plans for follow-up with GI and PCP. Prescribed Prednisone with taper off after 28 days. Follow-up appointment has not yet occurred as of the day this report is submitted(2/19/2021).
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| 39 | 2021-02-21 | chills |
3 days after vaccine I woke up with nausea, upset stomach. Symptoms resolved within 6 hours. 1 week...
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3 days after vaccine I woke up with nausea, upset stomach. Symptoms resolved within 6 hours. 1 week after vaccine, woke up at 3:00am with nausea and heat wave/chills, resolved within an hour
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| 39 | 2021-02-22 | chills, headache, malaise, fever |
Developed headache, chills within 10 hours after receiving second shot. Developed high grade fever w...
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Developed headache, chills within 10 hours after receiving second shot. Developed high grade fever within 24 hours, peak 102.5 F. Temperature started dropping a little bit within 48 hours, but still feeling very ill. Could not fall asleep for two consecutive nights. Had to take Tylenol twice to reduce the pain and fever on the third day. Temperature was brought back to normal on the fourth day. Had to take a sick leave.
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| 39 | 2021-02-22 | headache, nerve pain |
Headache for 2 days Body aches for 3 days Striking Nerve pain in my keloid under right breast after...
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Headache for 2 days Body aches for 3 days Striking Nerve pain in my keloid under right breast after first injection and second injection Body aches for 3 days Nauseous day 3 Dizzy day 2 and 3 Hives/itchy rash started day 2 and currently still have itching rash all over body.
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| 39 | 2021-02-22 | fever, chills, headache, malaise |
Pain at injection site, immediate but worsened w time, mild the next day. Nausea, chills, malaise, ...
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Pain at injection site, immediate but worsened w time, mild the next day. Nausea, chills, malaise, muscle and joint pain-started 15 hours after vaccine and lasted about 4-5 hours Fever up to 101.2- after nausea mostly resolved, lasted overnight Headache -24 hours
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| 39 | 2021-02-22 | fatigue, chills | Very minor chills, fatigue and muscle aches for about 3 hours. |
| 39 | 2021-02-23 | throat irritation, skin warm |
1 Welt/hive (redness, hot, itching, some raised area in center). Mild scratchy throat but unable to ...
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1 Welt/hive (redness, hot, itching, some raised area in center). Mild scratchy throat but unable to tell if from thirst from 45 min drive with no fluids or from vaccine. Observed for 30 min instead of standard 15. Given bottled water to drink. Released to work. Symptoms lasted about an hour from vaccination.
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| 39 | 2021-02-23 | throat irritation |
metallic taste in mouth; itchy throat that felt constricted; itchy throat that felt constricted; Thi...
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metallic taste in mouth; itchy throat that felt constricted; itchy throat that felt constricted; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142) intramuscular on the left arm on 30Dec2020 10:30 at a single dose for COVID-19 immunization. Medical history included pre-diabetes and known allergies: Penicillin. Concomitant medication included escitalopram oxalate (LEXAPRO). Immediately after the 1st dose on 30Dec2020, the patient experienced metallic taste in mouth followed by itchy throat that felt constricted. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown.
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| 39 | 2021-02-25 | throat irritation |
convulsing uncontrollably; stroke; rash; chest felt really heavy like someone was sitting on it; her...
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convulsing uncontrollably; stroke; rash; chest felt really heavy like someone was sitting on it; her throat felt like it was on fire; shaking uncontrollably/ arms and legs were shaking; Her speech was slurred, she could not communicate; Stuttering; dysphagia; tongue was falling to the side/mile was droopy on the right side/right arm- she would try to move it but it would not go/right leg was almost paralyzed; This is a spontaneous report from a contactable consumer (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 09Feb2021 18:10 at a single dose for COVID-19 immunization. The patient had no relevant medical history. She was healthy and takes no medications. The patient got the vaccine Tuesday night at 6:10 PM. She waited in the parking lot where she got it, which was through (School Name). She had a severe reaction and had to receive an Epi Pen. This reaction occurred maybe 10 minutes after she got it. She had not left the parking lot yet, so it was prior to the 15 minutes. She broke out in a rash, her chest felt really heavy like someone was sitting on it, like an elephant, and her throat felt like it was on fire which is what is started as, then it went to her ears. From there, it escalated. She had gotten out of her car and took her sweatshirt off, she thought she was just hot. As soon as she got back in the car and as soon as she got in she started convulsing uncontrollably and shaking uncontrollably. Two ladies she works with had parked next two her on both sides and they noticed this and went to get the emergency squad. She did not lose consciousness. She could still hear everything but her arms and legs were shaking, and her right leg was shaking and stuck. The emergency squad had to help her out of the car. The ambulance gave her an Epi Pen injection and the squad took her to the hospital. Her speech was slurred, she could not communicate. She was stuttering the same thing over and over. She had a CAT scan with contrast and the stroke team decided she needed TPA - the stoke medication. They administered that and admitted her to the hospital Tuesday night. Wednesday she had an MRI, echocardiogram and another CAT scan and they released her to come home last night. She is still having lingering effects. Her speech is back. Her arm movement is back. The reason they treated her as a stroke patient, they said, is because when they told her to stick her tongue out, she had dysphagia - her tongue was falling to the side, and her smile was droopy on the right side. Her right arm- she would try to move it but it would not go. And her right leg too. She could do everything on her left side and nothing on her right side. She was conscious and could hear but could not get anything to work. After receiving the TPA, Wednesday when she woke up, she was being checked on every 30 minutes throughout the night, she was able to speak and communicate. She will still stutter and have slow words but it is way better and she can communicate. Her right arm is able to move and she can use it but her fine motor is hard. Like writing stuff is a challenge. She also has a walker. Her right leg is almost paralyzed, it drags beside her as she walks. She can move but has to really concentrate to get going. She has not reached out to her doctor yet. She was admitted to the hospital and had a bunch of tests done. The Epi Pen gave her stroke like symptoms. They were not sure in the hospital if it was actually a stroke based on her 2 MRI's and CAT scans. It did not look like a stroke from those but they think that the Epi Pen and the stress it puts into your body made her body shut down. Which the Epi Pen they said can cause stroke like symptoms. They were unsure as they have seen multiple things with the vaccine come in over the last few weeks. They told her she would need to work on the therapies out-patient. She will have to have PT/OT for lingering effects she was suffering from. Outcome of events was recovered with sequelae.
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| 39 | 2021-02-28 | headache |
Itchy neck, arms, lower half of face; Hives on both arms.; Burning headache; This is a spontaneous r...
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Itchy neck, arms, lower half of face; Hives on both arms.; Burning headache; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL8982), via an unspecified route of administration in the right arm on 27Jan2021 08:45 at a single dose for covid-19 immunization. Medical history included hypothyroid, allergies to nausea medication and COVID 19. Concomitant medication included levothyroxine. On 27Jan2021 12:00, the patient experienced itchy neck, arms, lower half of face., hives on both arms and burning headache. The patient did not receive treatment for the events. The events were assessed non-serious. The outcome of the events was not recovered.
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| 39 | 2021-02-28 | fever, chills |
developed sharp left chest pain, fever, chills. Felt better with acetaminophen. On 2/27/2021 left...
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developed sharp left chest pain, fever, chills. Felt better with acetaminophen. On 2/27/2021 left chest pain returned and was so severe caused hospital ED visit and hospital admission
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| 39 | 2021-02-28 | fatigue |
patient with myelitis transverse received Pfizer Covid 19 vaccine; patient with myelitis transverse ...
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patient with myelitis transverse received Pfizer Covid 19 vaccine; patient with myelitis transverse received Pfizer Covid 19 vaccine; Paresthesias to bilateral hands to elbows, right foot/leg; brain fog; fatigue; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK-5730; expiration date: unknown) at 39-year-old age of vaccination intramuscularly in the left arm on 26Dec2020 11:30 at a single dose for covid-19 immunization. Medical history included myelitis transverse from 2015 to an unknown date and depression. The patient has no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive other vaccine in four weeks but has other medications in two weeks. It was reported that the patient with myelitis transverse received Pfizer Covid 19 vaccine on 26Dec2020. On Dec2020, the patient had paresthesias to bilateral hands to elbows, right foot/leg with brain fog and fatigue. Symptoms appeared approximately 12-18hrs after injection. There was no treatment receive for the adverse events. The events resolved 48 hours after. The adverse events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab (sars-cov-2 test) with the result of negative on 22Jan2021. The outcome of the events was recovered on Dec2020.
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| 39 | 2021-03-04 | head discomfort, fatigue, malaise |
Heavy headed; Sore; so tired that could only sleep; Felt unwell; Extreme tiredness/so tired that cou...
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Heavy headed; Sore; so tired that could only sleep; Felt unwell; Extreme tiredness/so tired that could only sleep; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL8982), via an unspecified route of administration in the left arm on 29Jan2021, at 14:15 as single dose for covid-19 immunization. Medical history included allergy to mangos from an unknown date. The patient felt unwell on 01Feb2021 with outcome of not recovered; extreme tiredness/so tired that could only sleep on 01Feb2021 with outcome of not recovered; heavy headed on 02Feb2021 with outcome of not recovered; sore on 02Feb2021 with outcome of not recovered. The events were reported as non-serious as no treatment was given for them. Prior to vaccination, no diagnosis of COVID-19 was noted, and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
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| 39 | 2021-03-07 | throat swelling |
did not have full anaphylaxis; a sense of her throat swelling; hives; This is a spontaneous report f...
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did not have full anaphylaxis; a sense of her throat swelling; hives; This is a spontaneous report from a contactable physician. A 39-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced "a sense of her throat swelling" and hives 1 hour after the vaccination occurred. The patient received 1 dose of Benadryl and Tylenol and "felt ok." The physician commented that the patient did not have full anaphylaxis and was asking if it would be safe for the patient to receive the second dose of the vaccine at the time of report. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 39 | 2021-03-18 | headache |
Debilitating headache; nausea; vomiting; ringing in the ears; L eye drooping; numbness and tingling ...
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Debilitating headache; nausea; vomiting; ringing in the ears; L eye drooping; numbness and tingling of lips; numbness and tingling of lips; trembling of R side of body; abnormal/change in gait; change in vision; hypertension; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number and Expiration date was unknown), first dose via an unspecified route of administration on an unspecified date, second dose via intramuscularly in right arm on 16Jan2021 15:30; both at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included depression, MTHFR (methylenetetrahydrofolate reductase), latex allergy. Concomitant medications included venlafaxine, L-methylfolate; the patient received both the drugs within 2 weeks of vaccination. The patient previously took fluoxetine, citalopram and experienced known allergies for both the drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. The patient experienced debilitating headache, nausea, vomiting, ringing in the ears, L eye drooping, numbness and tingling of lips, trembling of R side of body, abnormal/change in gait, change in vision, hypertension on 25Jan2021 06:00. On 01Feb2021, the patient underwent lab test and procedure included nasal swab/ COVID-19 by PCR: Negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was treated with IV Dexamethazone, Diphenhydramine, ketorolac, promethazine for all the events. The outcome of the events was not recovered. Information on the Lot/Batch number has been requested.; Sender's Comments: On the basis of the available information, the reported events debilitating headache, nausea, vomiting, ringing in the ears, L eye drooping, numbness and tingling of lips, trembling of R side of body, abnormal/change in gait, change in vision, hypertension would seem most likely related to intercurrent and/or underlying medical condition and concomitant medication, which is not related to bnt162b2. This case will be reassessed when additional information becomes available. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 39 | 2021-03-22 | fatigue, migraine, chills, headache |
Headache/Sharp pain across the forehead; chills; body aches; tiredness; severe migraine; This is a s...
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Headache/Sharp pain across the forehead; chills; body aches; tiredness; severe migraine; This is a spontaneous report from a contactable nurse, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 04Feb2021 at 14:45 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history included depression-anxiety and birth control use; the patient had no known allergies. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. Concomitant medications included vilazodone hydrochloride (VIIBRYD), drospirenone/ethinylestradiol betadex clathrate (YAZ) for birth control, clonazepam (KLONOPIN). The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 04Feb2021 at 15:00 (also reported as within 3 minutes post vaccination), the patient experienced headache as a sharp pain across the forehead. On 04Feb2021 at 15:00, the patient also experienced chills, body aches and tiredness that lasted 24 hours. The headache remained 6 days post vaccination as a severe migraine, as of an unspecified date in Feb2021, for which no medications worked. The patient iced, applied heat to the area, dark room, no sound for 2 days and finally was relieved with acupuncture. This headache was like no headache the patient had ever had and she had come very close to an emergency room visit but realized it was from the vaccine. The events "Headache/Sharp pain across the forehead" and severe migraine resulted in a healthcare professional visit and the patient was treated for these events with acupuncture. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "Headache/Sharp pain across the forehead" and severe migraine was resolving; chills, body aches and tiredness were resolved on 05Feb2021 at 15:00. Information on the lot/batch number has been requested.
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| 39 | 2021-03-30 | shortness of breath |
Anaphylactic reaction (I could not swallow, I was short of breath, I got 2 bruises on my face, nause...
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Anaphylactic reaction (I could not swallow, I was short of breath, I got 2 bruises on my face, nausea, tachycardia) at the first dose of the Pfizer vaccine, which I was treated immediately in the emergency room with Epinephrine, Benadryl, Decadron y Albuterol. I was discharged the same day. I was treated in observation at hospital.
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